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29 days old

Clinical Protocol Coordinator - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814
Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Kelly Government Solutions offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with the leading medical research center in the world. We are seeking an experienced individual to work as a Clinical Protocol Coordinator at the National Institutes of Health in Bethesda, MD.


This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package


+ Optional health, vision, and dental plans


-Vacation leave as well as 10 paid federal holidays and 401K plan.

- Access to NIHs unparalleled resources and niche scientific initiatives


TASKS/SERVICES. The contractor shall:


+ Prepare regulatory submissions for approval to initiate clinical studies of investigational vaccines and monoclonal antibodies targeting HIV and emerging infections.

+ Conduct quality control reviews of IRB applications and all forms and documents included in the submission packets.

+ Ensure that advice and actions of VRC/CTP staff are consistent with NIAID, NIH, and DHHS goals and policy, as well as with applicable statutes, regulations, rules, and directives of the NIH IRB.

+ Use information technology/telecommunication systems for data management and document control.

+ Work in conjunction with the research nurse and the monitoring staff to schedule and attend monitoring visits for VRC protocols and to resolve and address findings generated during the visit.

+ Prepare regulatory files for monitoring activities and interface with site monitors who conduct reviews of VRC regulatory files.

+ Maintain the electronic and paper regulatory binders for the VRC Clinic site as well as VRC Sponsor oversight.

+ Responsible for the administration, coordination, and management of the CTP activities related to the NIH Institutional Review Board (IRB) and the IRBs integrated research information system (iRIS).

+ Analyze and interpret regulations, policies and procedures and provide oral and written explanations and advice.

+ Assist in ensuring that all VRC/CTP scientists and clinicians involved in human subject research are educated in policies and procedures governing such research by means of information memos, compliance with required computer-based training, and dissemination of new information obtained by attendance at workshops and seminars.

+ Create, distribute, and track all IRB submissions in support of the VRC clinical trials activities. Logs all items in the tracking software used by VRC

+ Distribute IRB memoranda to Principal Investigator and other appropriate CTP staff. Provide input on timelines and plans for VRC activities related to regulatory reviews.

+ Review investigators responses to IRB stipulations for completeness and makes recommendations regarding the adequacy of the response.

+ Design and modify forms, letters, and memoranda to guide initial and continuing review of protocols, to maintain efficient operations within the CTP, and to avoid delay or impediment to VRC clinical research. Monitor the flow of documents in and out of the office in conformance with strict deadlines of the NIH IRB.

+ Track studies and communicates with investigators concerning the status and requirements for continuing reviews.

+ Serve as a resource concerning procedures and regulations for initial IRB submission and continuing review of clinical protocols. Informs potential investigators and advises them of the documentation and approvals they will need to initiate a clinical study, based on the type, location, and complexity of the protocol.

+ Attend meetings of the CTP as well as the meetings related to the NIH IRB and works with clinical and regulatory staff to update policies and procedures.

+ Maintain current knowledge of policies and regulations from the DHHS, FDA, OHRP, HSR, NIAID, and NIH for the implementation of clinical studies.

+ Provide input to the development and updating of CTP protocol manuals that are used as a reference for the conduct of clinical trials. Interpret, synthesize, and clarify relevant changes or proposals in NIH or VRC regulatory policy or procedures and standing policies.

+ Manage oversite of all the required trainings for CTP staff members as well as required medical licenses, Curriculum Vitaes and trainings for the clinical staff. Ensure that trainings are current and remind staff when renewal is required.


REQUIREMENTS. The contractor must have:


+ Masters degree in Life Sciences or other related discipline. Two (2) years of specialized experience plus a BA/BS degree is equivalent to a Masters degree.

+ Minimum of two (2) years of experience in a related field. Expertise in the fundamentals of clinical trials.

+ Experience in clinical data management and monitoring, database operations and analysis. Familiarity with IRB requirements.


**PLEASE APPLY ONLINE**

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.


Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you arent contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.


As a specialty talent company, Kelly is committed to doing the right thing for our talent and clients . We stand up for equity, inclusion, fair treatment, and opportunity for all as these build the foundation of our Talent Promise. With a focus on safety, value, well-being, investment, and opportunity, Kellys Talent Promise confirms our commitment to those in search of a better way to work and live and to help discover whats next.


It is obvious things are different than they were just a few months ago. Kelly is at the forefront of ensuring the safety of our employees in this new working environment. Be well and stay strong.


**Why Kelly** **** **?**


Looking to connect with premier government agencies or the top 25 federal government contractors? Kelly Government offers a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technical, professional, and administrative support roles. Our experts will find you the opportunity that fits your schedule and interests and handle the details of transferring and processing all levels of security clearances. Its just another way we make the job search work for you.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-08-18 Expires: 2021-09-18

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Clinical Protocol Coordinator - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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