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Clinical Research Support Services

About our services .

The Clinical Research Support Office is a highly productive, cost-effective research service program that provides support across the lifecycle of a clinical research study. Our staff has expertise in implementing, conducting and monitoring clinical research studies, providing services that benefit both novice and experienced clinical researchers.

Research Navigation

We provide support across the lifecycle of clinical research through expert research navigators, who help investigators operationally launch their studies, as well as offer services investigators need to run efficient, safe and high quality clinical research and trials. Please contact us directly to get started with a Research Navigator or visit our Clinical Research Support Office internal site (log in required) for more information.

To reach out to us directly, please contact:

Shannen Nelson RN, MSN, CCRP, CCRC  Director, Operations, Clinical Research Support Office  Ph: 323-361-8685 | Email: [email protected]   or  Sharon Tang, BS, CCRC  Associate Director, Operations, Clinical Research Support Office  Ph: 323-361-7299 | Email: [email protected]

Clinical Research Coordinator Pool

Our dynamic pool of clinical research coordinators (CRCs) support research studies across the clinical divisions of Children’s Hospital Los Angeles. The CRCs are centrally managed and trained, certified by internationally recognized certification programs for clinical research professionals (CCRP or CCRC), and collectively provide a broad range of knowledge and expertise about conducting pediatric clinical research studies and trials at the hospital. Depending on the complexity of a study protocol, a CRC will be allocated based on experience to meet the demands of implementing the study while remaining sensitive to a project’s budgetary parameters.  They are available on a fee-for-service basis to join your study team to help implement and conduct all aspects of a study from start-up to closeout.

Regulatory and IRB Support

Regulatory support is critical for any research study or clinical research, especially when it involves children. Each study requires rigorous institutional and federal regulatory review and documentation, including approval by the Institutional Review Board (IRB). Our Research Regulatory Support & Recruitment Specialist provides the research community at CHLA with support and guidance, as well as assistance in coordinating regulatory affairs for clinical trials and research studies.

For guidance & regulatory assistance on the policies & procedures regarding research & clinical trials at CHLA - CONTACT: [email protected]  

Education & Training

Our staff provides ongoing clinical research education and training to researchers and staff throughout the hospital. This includes monthly seminars, online resources and 1-on-1 trainings with topics covering the lifecycle of clinical research, including; IRB applications, study start up, clinicaltrials.gov registration, IND/IDE regulations, consenting participants and much more. 

For guidance & training for clinical research coordinators and research assistants on conducting research & clinical trials at CHLA - CONTACT: Andrea Smith, CCRP - Education Specialist, Clinical Trials Unit (CTU) Supervisor,  Ph: 323-361-6302 [email protected]

Recruitment Planning & the Clinical Research Study Directory

Having volunteers participate in research studies and clinical trials is critical to our research efforts, which is why we’ve created a CHLA Research Study Directory. Check out chla.org/researchstudies and let patients and parents know how they too can impact the lives of children. Volunteer opportunities are available for healthy children as well as those with certain conditions. 

For assistance with recruitment strategies, tools, templates and to get your study listed on the website CONTACT: [email protected]

Clinical Trials Unit

Our Clinical Trials Unit (CTU) is a program of the Southern California Clinical and Translational Science Institute. The CTU is located on the first floor in the main hospital building, in a 1,625 square foot outpatient facility, alongside the Children’s Health Imaging Research Program with four dedicated patient care areas for research participant evaluations and interventions, as well as a research laboratory for specimen processing. The CTU provides the infrastructure necessary to assist investigators in performing clinical research studies with outpatient and inpatient research visits. We successfully service multiple CHLA divisions and roughly 100 research protocols. The success of our division is a direct result of our hard work and high standards.  We welcome and encourage investigators to contact  the CTU early in the process of initiating (preferably during study start-up) his/her research study by contacting the CTU directly. This will allow for the investigator to know what to expect with the operations and budget of his/her study.

If you are thinking of performing a research study or need support & guidance for an ongoing study CONTACT: Lauren Rowley, MBA, BSN, RN, PHN, BMTCN – Associate Director, Clinical Trials, Phone: 323-208-2603 , Email: [email protected]

Research Nurses

Our dedicated research nurses conduct protocol-specific activities such as detailed assessments, venipuncture, IV insertion, EKGs, patient monitoring, vital signs, patient teaching, medication administration (oral, nasal, subcutaneous injections, and intramuscular injections), PK sampling, drug and pregnancy testing, STI testing, oral glucose tolerance tests, and more. Our nurses are available in the CTU and can also travel to clinics as needed to facilitate patient participation.

For more information about the CTU and Nursing support CONTACT: Lauren Rowley, MBA, BSN, RN, PHN, BMTCN – Associate Director, Clinical Trials, Phone: 323-208-2603 , Email: [email protected]  

Research Studies

Children’s Hospital Los Angeles is a premiere destination to host clinical research studies. Please refer to this PDF about clinical research at CHLA for more information.

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Clinical Research Support Services News

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Research Support Services

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Our Mission 

The mission of the Research Support Services office is to assist investigators in navigating the complex human research process at Vanderbilt University.  Research Services Consultants, experienced professionals in conducting research or Institutional Review Board activities, provide guidance in the following areas:

  • Study organization
  • IRB navigation
  • Protocol development
  • Preparation of study related documents
  • Funding and contractual agreements
  • Overall program advisory (IMPACTT)

Research Services Consultants (RSC) are available to provide individualized consultation, by telephone, email or in person on a variety of research related topics.

Vanderbilt Institute for Clinical and Translational Research (VICTR)

Research Support Services is one of the many resources available through VICTR, which is Vanderbilt's virtual home for clinical and translational research. Supported by the Office of Research and the National Institutes of Health (NIH) sponsored Clinical and Translational Science Award (CTSA), the mission of the institute is to transform the way ideas and research discoveries make their way from origin to pateint care. 

StarBRITE , launched in October 2007, is an interactive system that provides one stop shopping for research needs.  You can find a variety of different resources such as Pilot Funding, REDCap, ResearchMatch, BioVU, Clinical Research Immersion Boot Camp and much more.  Note: Access is limited to individuals with a VUMC ID. External users who would like to learn more about VICTR and it's resources can visit our VICTR public website . 

Research Support Services 2525 West End Ave., 6th Fl. Nashville, TN 37203-8820

RSS Hotline: (615)-322-7343

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Clinical Trial Support Through Comprehensive Services, Robust Trial Data, Enhanced Collaboration, Impactful Results

Guide the journey for patients, sites, sponsors, and CROs with Scout’s tailored service offerings and white-glove attention to detail.

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Increase engagement and boost retention with clinical trial support in travel, payments, and more to help patients stick with it.

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Keep your people on the same page with a reliable, 24/7 resource for consistent, high-quality training.

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Innovation in service, unparalleled attention to detail. This is what it really means to Scout out your study.

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Making the complex easier. Scout’s honor.

We empower the life sciences with services that support ease and efficiency. Go beyond just getting things done: We’re about streamlining processes, saving time and resources, and enhancing the experience from start to finish.

People. First. Solutions.

Better treatments and healthier tomorrows start with smooth-running studies. We help increase collaboration, minimize attrition, and help everyone involved go the distance for more robust clinical trials.

Keep Your Trial On Track

From patient logistics to site education and everything along the way, all of our services are geared with the same goal in mind: Keep your study moving in order to get new drugs and therapies to market and help more people. Simple as that.

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Pat Bingham established Meeting Protocol, the company which would eventually become Scout, in 1995. Discover how where we’ve been informs where we’re going.

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SCOUT'S STRATEGIES FOR OPTIMIZING CLINICAL TRIALS IN FRANCE

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MEETING DIVERSE NEEDS IN GLOBAL CLINICAL TRIALS

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HYBRID SOLUTIONS FOR NAVIGATING THE CROWDSTRIKE OUTAGE

Chart the course to success.

Imperial Receives Platinum Award for Clinical Trial Video! Learn more

Study and site print materials, clinical trial translation management, ancillary trial supplies and equipment, clinical trial patient engagement, cro-centered services.

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What We Do For Clinical Trial Services

Imperial’s clinical trial services take on every one of your study's challenges, from study startup and site technology support to reclamation and disposition, and everything in between. Your goals are ours, and that means your study is in the right hands.

Site tools and materials for study management, data collection, and patient engagement have long been an Imperial specialty. With the creative team and the printing operation at a single company, you will experience streamlined precision unavailable elsewhere. And we are experts at crossing the finish line: We create, print, fulfill, and distribute more than 50,000 shipments annually into over 100 countries for our clients. 

Our team provides translation services into more than 130 languages and dialects. Translators are vetted, in-country, experienced professionals, ensuring the highest quality and accurate translations. Excellence is our passion: Imperial Translation Services’ quality management system is certified to the ISO 9001:2015 standard.

We do more than procure – our team manages expiry, technology programming, repackaging, and all related activities to maximize protocol compliance. Working hand in hand with your teams, we research the most effective in-country solutions for your study.  And we specialize in getting your supplies and equipment to their destination, including countries that are international red-tape challenges.

Imperial gives you evidence-based global support services for subject recruitment and retention based on decades of experience. Our award-winning creative services and messaging solutions are proven to drive study interest and obtain results in the patient, caregiver, and medical communities.

After more than a decade of working with clinical research organizations, we’ve developed clinical research support services tailored to help CROs achieve greater efficiency and trial success.

A La Carte or Comprehensive Services

Imperial can support your needs, whether you’re looking for start-to-finish site management or specific clinical trial support services, including study and site materials, ancillary supplies and equipment, clinical translation management, and patient engagement.

Below are additional details of the specific areas where Imperial will help with your clinical trial.

Study Startup

We utilize 40+ years of clinical trial experience to review your study’s protocol. We look at target areas, patient populations and demographics, along with the protocol’s unique attributes and requirements. A comprehensive study-specific plan is derived that meets your unique ancillary supply and equipment needs. Startup services include:

  • Budget management
  • Investigator meeting supplies and materials
  • High-quality translation services
  • Physician, site, and patient engagement materials
  • Supply procurement
  • Supplies delivery
  • Equipment calibration compliance
  • Storage and global allocation as needed by sites
  • Labeling and packaging
  • Site staff training

Cutting through international red tape is our specialty. We get your supplies to their global destinations on time through exclusive digital platforms and resources to stay on top of ever-changing compliance regulations, including:

  • Sales tax compliance
  • Licensing for medical devices, textiles, dangerous goods
  • Reporting on improvement
  • Importer of record services

Ongoing Management

Our highly skilled project managers will help you keep your study on track with ongoing evaluations to anticipate future requirements. We are also skilled at stepping anywhere into your timeline for rescue situations. We specialize in patient recruitment, even when your study is not meeting enrollment. And we’re the best at procuring the right supplies and getting them to their international destinations. Management services include:

  • Sunshine Act reporting
  • Regulatory reporting
  • Inventory management
  • Supply and resupply
  • Equipment maintenance, repair, and demand planning

Study Closeout

Our team will help you wrap up all details and materials, including documentation, reporting, products, accountability, inventories, and review. Our expertise includes:

  • Legal compliance
  • Reconciliation
  • Store and reuse
  • Tax qualifying donations
  • Confidential disposal/destruction
  • Distribution of final patient data to sites

Meet Your Study Goals Without the Hassle

Combine 6-8 suppliers into one and simplify life for your study operations teams.

Master the 5 Key Processes for Ancillary Supplies and Equipment Procurement

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Download our brand new ebook to assess real-world examples of how applying a systematic, structured approach can reduce costs, save time, mitigate risks, and improve study effectiveness.

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Research Support Portals

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What research gets submitted to DF/HCC; Education; Onboarding; Policies and Requirements

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Submitting new studies and managing ongoing studies in treatment-based (clinical) research.

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Submitting new non-treatment/non-clinical studies, and managing ongoing studies.

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DF/HCC Research Support Offices

These three offices support and maintain the resources, guidance, and systems and processes that you will find on this website. Find more information about each office, their key functions, and who to contact for help below.

For general DF/HCC contact information, click here .

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Updates & Events

August 27, 2024 –  ODQ

ClinicalTrials.gov Modernized PRS effective August 28, 2024

The ClinicalTrials.gov website will receive major modernizing updates beginning August 28th. To help facilitate this transition, ODQ has created a brief video walkthrough of the updated platform...

June 25, 2024 –  OHRS

DF/HCC Onboarding Webinars - New 2024 Sessions

The DF/HCC Education Working Group is excited to announce the continuation of our DF/HCC Onboarding Webinars! Read on for more information and to register for a session...

April 08, 2024

Pre-Submission Form - New!

Review details and guidance about the new Pre-Submission Form and process, required for all applicable new protocol submissions!

Masks Strongly Recommended but Not Required in Maryland, Starting Immediately

Due to the downward trend in respiratory viruses in Maryland, masking is no longer required but remains strongly recommended in Johns Hopkins Medicine clinical locations in Maryland. Read more .

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Understanding Clinical Trials

Clinical research: what is it.

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Your doctor may have said that you are eligible for a clinical trial, or you may have seen an ad for a clinical research study. What is clinical research, and is it right for you?

Clinical research is the comprehensive study of the safety and effectiveness of the most promising advances in patient care. Clinical research is different than laboratory research. It involves people who volunteer to help us better understand medicine and health. Lab research generally does not involve people — although it helps us learn which new ideas may help people.

Every drug, device, tool, diagnostic test, technique and technology used in medicine today was once tested in volunteers who took part in clinical research studies.

At Johns Hopkins Medicine, we believe that clinical research is key to improve care for people in our community and around the world. Once you understand more about clinical research, you may appreciate why it’s important to participate — for yourself and the community.

What Are the Types of Clinical Research?

There are two main kinds of clinical research:

Observational Studies

Observational studies are studies that aim to identify and analyze patterns in medical data or in biological samples, such as tissue or blood provided by study participants.

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Clinical Trials

Clinical trials, which are also called interventional studies, test the safety and effectiveness of medical interventions — such as medications, procedures and tools — in living people.

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Clinical research studies need people of every age, health status, race, gender, ethnicity and cultural background to participate. This will increase the chances that scientists and clinicians will develop treatments and procedures that are likely to be safe and work well in all people. Potential volunteers are carefully screened to ensure that they meet all of the requirements for any study before they begin. Most of the reasons people are not included in studies is because of concerns about safety.

Both healthy people and those with diagnosed medical conditions can take part in clinical research. Participation is always completely voluntary, and participants can leave a study at any time for any reason.

“The only way medical advancements can be made is if people volunteer to participate in clinical research. The research participant is just as necessary as the researcher in this partnership to advance health care.” Liz Martinez, Johns Hopkins Medicine Research Participant Advocate

Types of Research Studies

Within the two main kinds of clinical research, there are many types of studies. They vary based on the study goals, participants and other factors.

Biospecimen studies

Healthy volunteer studies.

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 Goals of Clinical Trials

Because every clinical trial is designed to answer one or more medical questions, different trials have different goals. Those goals include:

Treatment trials

Prevention trials, screening trials, phases of a clinical trial.

In general, a new drug needs to go through a series of four types of clinical trials. This helps researchers show that the medication is safe and effective. As a study moves through each phase, researchers learn more about a medication, including its risks and benefits.

Is the medication safe and what is the right dose?   Phase one trials involve small numbers of participants, often normal volunteers.

Does the new medication work and what are the side effects?   Phase two trials test the treatment or procedure on a larger number of participants. These participants usually have the condition or disease that the treatment is intended to remedy.

Is the new medication more effective than existing treatments?  Phase three trials have even more people enrolled. Some may get a placebo (a substance that has no medical effect) or an already approved treatment, so that the new medication can be compared to that treatment.

Is the new medication effective and safe over the long term?   Phase four happens after the treatment or procedure has been approved. Information about patients who are receiving the treatment is gathered and studied to see if any new information is seen when given to a large number of patients.

“Johns Hopkins has a comprehensive system overseeing research that is audited by the FDA and the Association for Accreditation of Human Research Protection Programs to make certain all research participants voluntarily agreed to join a study and their safety was maximized.” Gail Daumit, M.D., M.H.S., Vice Dean for Clinical Investigation, Johns Hopkins University School of Medicine

Is It Safe to Participate in Clinical Research?

There are several steps in place to protect volunteers who take part in clinical research studies. Clinical Research is regulated by the federal government. In addition, the institutional review board (IRB) and Human Subjects Research Protection Program at each study location have many safeguards built in to each study to protect the safety and privacy of participants.

Clinical researchers are required by law to follow the safety rules outlined by each study's protocol. A protocol is a detailed plan of what researchers will do in during the study.

In the U.S., every study site's IRB — which is made up of both medical experts and members of the general public — must approve all clinical research. IRB members also review plans for all clinical studies. And, they make sure that research participants are protected from as much risk as possible.

Earning Your Trust

This was not always the case. Many people of color are wary of joining clinical research because of previous poor treatment of underrepresented minorities throughout the U.S. This includes medical research performed on enslaved people without their consent, or not giving treatment to Black men who participated in the Tuskegee Study of Untreated Syphilis in the Negro Male. Since the 1970s, numerous regulations have been in place to protect the rights of study participants.

Many clinical research studies are also supervised by a data and safety monitoring committee. This is a group made up of experts in the area being studied. These biomedical professionals regularly monitor clinical studies as they progress. If they discover or suspect any problems with a study, they immediately stop the trial. In addition, Johns Hopkins Medicine’s Research Participant Advocacy Group focuses on improving the experience of people who participate in clinical research.

Clinical research participants with concerns about anything related to the study they are taking part in should contact Johns Hopkins Medicine’s IRB or our Research Participant Advocacy Group .

Learn More About Clinical Research at Johns Hopkins Medicine

For information about clinical trial opportunities at Johns Hopkins Medicine, visit our trials site.

Video Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

Clinical Research for a Healthier Tomorrow: A Family Shares Their Story

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Clinical Research Administration

Regulatory compliance, support for your human subjects research projects.

Save time, reduce hassles and open your study quicker. CRS is a team of highly motivated individuals with significant expertise in human subjects research rules, regulations, best practices and operations. We provide guidance and support to our faculty and their teams.

Announcing: New Director of Clinical Research Administration

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AtlantClinical

Atlant Clinical is a strong multinational Contract Research Organization (CRO) offering a full range of clinical trial and relevant support services throughout the US, Europe, Russia, and Middle Asia. We are a highly professional team with extensive clinical experience (Phases I–IV) in over 15 therapeutic areas.

Our mission is to aid pharmaceutical and biotech companies with the delivery of new drugs and medical products to patients in the shortest time possible. We take pride in the utmost quality of service, transparency of operations, and full commitment to improving the lives of people around the world.

WIDE GEOGRAPHICAL COVERAGE

On the ground presence around the world

OPERATIONAL FLEXIBILITY

We’re always ready to tailor services directly to your needs

Impeccable service and quality across all of our operations

STUDY RESCUE

We’re prepared to step in if you need us – patient recruitment within tight timelines and unique study parameters

RISK-SHARING

We’re not just a CRO – We’re your partner

We are always glad to meet you at international and local exhibitions, conferences and forums dedicated to clinical trials.

OUR SERVICES

Established in 2007, our international CRO offers extensive experience and expertise in Phase I-IV clinical trials and a vast number of support services.

ATLANT CLINICAL AT A GLANCE

Atlant Clinical, a reliable and efficient provider of clinical research services in the USA, Europe, Meddle Asia and Baltic States.

We conduct trials ICH GCP guidelines, all applicable international and local regulations and legislation, and any requirements specific to the project. 

WHY ATLANT CLINICAL

With competition fierce and budgets tight, the world's leading pharmaceutical and biotechnology companies need a clinical  trials partner they can rely on. 

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This Brown Bag session discusses the institutional compliance responsibilities for clinical research contracts.

Watch this Brown Bag on myLearning .

Karen Roz,  Sr. Director of Research Administration, School of Medicine, Clinical Trials

Johns Hopkins University Research Administration

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Accell Clinical Research

When you absolutely have to recruit patients on time

Home 5 About Us

A DECADE OF SERVICE

2007 – opening of the clinical headquarters.

Accell is established as a clinical CRO providing Phase I – IV clinical study management services. The company serves as a reliable partner in completing clinical studies on time, and the first three Phase II oncology studies are initiated.

2008 – First European Oncology Project

Accell begins working in Europe on the first project with breast cancer patients, covering Sweden, Germany, France, Baltic countries, Russia and Ukraine.

2014 – Opening of a Regional Office in Ukraine

To provide regulatory services, Accell establishes a regional clinical office in Kiev, Ukraine. Our clients gain reliable access to a largely untapped patient population with the Accell's rigorous quality management practices applied.

2015 – US Business Office Moves to Virginia

Located near Charlottesville, VA, with easy access to Washington, D.C., Northern Virginia and Maryland, our Virginia office serves as a strong anchor for the outreach to East Coast biopharmaceutical industry.

2017 – Regional Office Opened in Latvia

Accell open a regional clinical office in Riga, Latvia to meet the demand for regulatory and pharmacovigilance services in the European Union. An Latvian office facilitates regulatory reporting in the European Union.

HANDS-ON FOUNDERS: A DIFFERENT LEVEL OF SUPPORT AND CONFIDENCE

Our journey started when working side-by-side on clinical studies we realized the tremendous financial waste created by study delays. All of the studies we worked on together had one thing in common: they could absolutely take no risk of running behind schedule. We saw first-hand that in our region the patients frequently received better care and treatment access within the clinical trial. This was hope for the cure for many. We knew we could promise both, our clients and the patients, better outcomes. So, we put together our heads, hands and hearts, and Accell Clinical Research was born. – Natalia Nayanova & Julia Kondakov, Founders

GLOBAL CHALLENGES IN CLINICAL TRIALS

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80% of all clinical trials fall behind schedule due to patient recruitment. 50% of sites enroll only 1 patient

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Nearly one-third of sites performing clinical trials never enroll a single patient

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Almost $2B spent on underperforming sites in 4 years by global pharma community

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Protocol complexity increases are proportional to enrollment rate decreases

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Natalia Nayanova, MD, MBA

Managing Member

Philip SIgalov, Director of Clinical Operations at Accell Clinical Research

Philip Sigalov, MD, PhD

Director of Clinical Operations

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Elena Gorelova

QC/QA Manager

We are here when you need us. Get in touch and let’s start something great together.

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Research Navigator

The CTSI Research Navigator provides counsel and direction regarding resources, processes, and expertise for conducting clinical and translational research at the University of Minnesota. 

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Clinical research practitioner - ophthalmic imaging technician, main area: research and development, grade: band 5, hours: full time, part time - 37.5 hours per week, job ref: 188-thq2290824, site: southampton general hospital, town: southampton, salary: £29,970 - £36,483 pa or pa pro rata, closing: 10/09/2024.

An exciting opportunity is now available at University Hospital Southampton NHSFT for a highly motivated Clinical Research practitioner to join our Ophthalmology Research delivery team.

You will join a friendly and enthusiastic team, working closely with the clinical MDT to lead the way to improved care and treatments alongside developing your career in Research Imaging. We run a 24/7 service, though most of your time will be spent working Monday to Friday office hours. 

Key Responsibilities 

You will lead in all aspects of Ophthalmic Imaging and provide specialist research and clinical care to research participants within the scope of your education and training. This includes identifying and approaching eligible patients, consenting patients, and supporting the delivery of study interventions and clinical investigations and the data collection required for the individual studies.

You will take on the responsibility for managing and coordinating delegated research studies; you will be guided and mentored by our experienced senior research nurses and Allied Health Professionals to develop within your role in providing gold-standard care to our patients.

Working in clinical research, protecting the patient from harm and maintaining their rights is essential and may involve acting as a patient advocate.

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Alberta Health Services

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Administrative Support II - Clinical Trials Assistant, Lung Group

🔍 edmonton zone, edmonton, cross cancer institute, your opportunity:.

The Clinical Trials Assistant (CTA) is a multi-skilled position that supports various CTU staff including project managers, research nurses and coordinators within a team, or several teams, and is a key administrative liaison and support for several projects. Responsibilities include helping to organize and complete various regulatory tasks associated with the initiation or maintenance of clinical trials conducted under Good Clinical Practices, as well as data entry completion for patient follow-up and survival. They help set up study patient and monitoring visits, complete meeting and appointment bookings, archive documents, organize study & lab supplies, and ensure the completeness or delivery of relevant documentation. The incumbent must demonstrate the ability to recognize and maintain confidential information, have highly developed organizational skills, and keen attention to detail. They will also multi-task effectively in a busy area with multiple interruptions and competing demands and have good problem solving and communication skills. They can work cooperatively and professionally with clinical trials staff and physicians. Lastly, they are able to function both independently and as a team member in a fast paced, dynamic office environment. This position will support our Lung team primarily but may assist or be reassigned to other groups as needed within the Unit.

Description:

As an Administrative Support II, you will require administrative or specialized skills and knowledge to support procedures, practices and initiatives within a department or program.

  • Recovery Alberta: N
  • Classification: Administrative Support II
  • Union: AUPE GSS
  • Unit and Program: Clinical Trials Unit, Cancer Care
  • Primary Location: Cross Cancer Institute
  • Location Details: As Per Location
  • Multi-Site: Not Applicable
  • Posting End Date: 09-SEP-2024
  • Employee Class: Regular Full Time
  • Date Available: 14-OCT-2024
  • Hours per Shift: 7.75
  • Length of Shift in weeks: 2
  • Shifts per cycle: 10
  • Shift Pattern: Days
  • Days Off: Saturday/Sunday
  • Minimum Salary: $21.30
  • Maximum Salary: $25.89
  • Vehicle Requirement: Not Applicable

Completion of Grade 12 or equivalent.

Post-secondary education, in a health-related field preferred (equivalent combinations of related education and experience will be considered). 1-2 years’ experience in a clinical trials/research setting, and an understanding of clinical trial start-up, processes, documents and prior data entry experience. (Preference given to candidates with prior clinical trials experience or training.). Excellent computer skills; must be proficient in Microsoft Outlook, Word, Excel and Adobe Acrobat programs. Ability to multi-task effectively in a busy area with multiple interruptions and competing deadlines and demands. Prior experience working with databases and knowledge of document management systems. Must be able to lift and transport large volumes of charts, binders, lab kits, boxes, etc., to various areas on a regular basis, and push/pull loaded carts. Physical demands of the job include sitting for extended periods, lifting and transporting office/medical supplies and equipment weighing up to 40 lbs., and using repetitive motions, lifting, bending, reaching and standing for prolonged periods. To ensure your skills and qualifications are considered please attach a resume and cover letter with your application.

Experience completing or maintaining clinical trials documentation and supplies. Prior experience with databases or document management systems. Training in Good Clinical Practice, ICH and Health Canada Regulatory requirements.

Please note:

All postings close at 23:59 MT of the posting end date indicated.

Security Screening:

A satisfactory criminal record check and/or Vulnerable Sector Search is required prior to your first day of work. Additionally, all employees have an ongoing duty to disclose any charges or convictions that may occur during their employment with AHS.

clinical research support services

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Home   >   Researcher Resources  >  Clinical Research Quality (CRQ) > CRQ ClinicalTrials.gov Support Services

CRQ ClinicalTrials.gov Support Services

Clinical Research Quality (CRQ) provides support to Stanford investigators and staff who need to submit information to the ClinicalTrials.gov registry and results databank.

Request CRQ services

Log into the ClinicalTrials.gov Protocol Registration & Results System

CRQ ClinicalTrials.gov Support Resources

Users now land on PRS Beta when logging in

Determine registration and results reporting requirements:
Most requirements apply to clinical trials

Determine who is responsible for ClinicalTrials.gov activities:

Understand when initial registration, updates, and results are expected:

Publishers require registration prior to enrollment of any participant; they also expect a to be included in the registration.

(ICMJE: International Committee of Medical Journal Editors)

Speed your entry and avoid ClinicalTrials.gov QC Review comments.

Includes definitions, tips, and Stanford-specific information

Results resources: use them to plan ahead, and at the time of results submission.

For most federally funded trials, a copy of the blank ICF must be posted any time after the trial is closed to recruitment, but no later than 60 days after the last study visit by any subject.

Includes specific instructions for when and how to post a blank ICF to ClinicalTrials.gov (or Regulations.gov)

How to create study documents that can be uploaded to ClinicalTrials.gov

How to create a (required in grant applications for NIH-funded clinical trials).

ClinicalTrials.gov information is downloaded nightly and used to populate the Stanford Clinical Trials website.

See ClinicalTrials.gov Regulations, Policy, and References

INVITRO is a provider of full Central laboratory services and Clinical trial management services for Phase I-IV.

INVITRO Laboratory also performs Local laboratory services for International clinical trials. Because of our broad experience and specialized expertise, we’re in unique position to support safety laboratory tests as an alternative to the different site bases.

clinical research support services

Local laboratory services are offered for Russia, Belarus and Kazakhstan

INVITRO Clinical Research can use its own Courier logistics service for pick-up and delivery of samples to the laboratory.

Due to the absence of custom between these countries, we are one of the small groups of organization with the capability and expertise to conduct Laboratory services and development projects for either local or global clinical trials.

All the tests for Clinical trials are performed in the Moscow laboratory.

It is stocked with high-tech equipment and located in a space of 3 500 sqm including:

  • 365 work days per year, including monitoring and registration of biological samples around the clock
  • Quality assurance of laboratory services in accordance with ISO 9001, ISO 15189 certificates
  • Validated methodologies, logistical and data management support, reliable and flexible reporting systems and cohesive quality control, which are critical to meet the requirements of your organization and regulatory agencies.

Our Project teams perform ongoing monitoring and proactive communications to provide high-quality outcomes. Protocol specifications are built in during database setup to provide customized reports and sophisticated result flagging for monitoring. Our secure Internet-based, remote data access system allows members of the project team to review lab results in real time. INVITRO scientists, technologists and project managers can assist with protocol development to provide the most appropriate tests for each study, and all INVITRO staff is trained and certified accordingly. INVITRO Laboratory offers the flexibility required for quick and customized responses to unique client needs for any size project.

We strongly believe that a collaborative relationship between INVITRO Laboratory and Clinical Investigators is fundamental study success.

We provide:

  • Design of study-specific manual
  • Lab Kit manufacturing in accordance with GLP requirements
  • Study-specific requisition forms and courier documents
  • Biomaterial transportation in compliance with IATA requirements
  • Telephone assistance
  • Specimen handling
  • Long-Term Storage and frozen specimen tracking
  • Personal Account of clinical trials – an opportunity to use a tool that allows you to monitor the results of laboratory research, query, order a courier and lab kits online and have access to laboratory documents and project -specific documents

INVITRO clinical research

  • Patient service
  • Project Management
  • Request for proposal

Invitro Clinical Research

INVITRO Clinical Research has supported clinical study teams at pharma companies and CROs facing the challenges of recruiting study subjects

www.invitro-cr.com

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    CRQ ClinicalTrials.gov. Support Services. Clinical Research Quality (CRQ) provides support to Stanford investigators and staff who need to submit information to the ClinicalTrials.gov registry and results databank. Request CRQ services. Log into the ClinicalTrials.gov Protocol Registration & Results System.

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