17 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 one of the most prestigious research organizations in the world. We are currently seeking a **Clinical Protocol Coordinator - NIH - Bethesda, MD** to work onsite with the National Institutes of Health in **Bethesda, MD** .

This is a long-term contract position which offers:

+ Competitive salary with comprehensive benefit package

+ Tremendous growth opportunity

+ Opportunity to work at NIH, the world's foremost medical research center

+ Learn more about what Kelly can do for you at

TASKS. The contractor shall:

**Protocol navigation and regulatory writing**

+ Provide clinical trials regulatory support through the NINDS Clinical Trials Unit (CTU) for the NINDS Intramural Research Program, including specific assigned groups.

+ Work with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, problem reports, including all necessary forms.

+ Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents.

+ Review and ensure protocols and informed consents meet regulatory requirements and are written in a compatible format with the guidelines.

+ Work with research teams and NINDS Clinical Trials Unit (CTU) staff to prepare submissions to the appropriate regulatory bodies (e.g. Institutional Review Board, Data and Safety Monitoring Entity, Radiation Safety Committee, among others).

+ Protect and ensure the safety of patients on research protocols through reporting of toxicities, trends in protocol results, and other concerns to the Principle Investigator( PI) and Medically Responsible Investigator (if not the PI).

+ Collaborate with staff on IND and IDE safety, clinical study reports and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports.

+ Manage, track and coordinate regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development, through the protocol lifecycle, to study closures.

+ Maintain all regulatory trial documentation including maintaining a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs and safety reports

+ Work with PI and associated research staff on the coordination and scheduling of monitoring and auditing visits by various regulatory bodies.

+ Organize regulatory protocol meetings and/or reports, as well as attend other research team staff meetings; interact closely with the research clinical team and other staff involved in protocol management; guide the protocol navigation process.

**Program support as protocol navigator**

+ Work with the NINDS Clinical Trials Unit (CTU) and NINDS staff on the development and preparation of standard operating procedures (SOPs) pertaining to protocol navigation and regulatory writing for the NINDS Intramural Research Program.

+ Prepare draft documents for senior staff review.

+ Attend in-person meetings located at the NIH campus in Bethesda including weekly CTU staff meetings, protocol development meetings, research coordinator forum meetings, as well as regular research team meetings.

+ Initiate and oversee revisions to documents as indicated in corrective and preventive action plans.

+ Collaborate with NIH clinical research scientists, Principal Investigators, Research Coordinators, Protocol Navigators, CTU-staff, and safety, regulatory, and monitoring entities.

+ Coordinate with other offices (e.g., Office of Human Subjects Research Protections, Office of Regulatory Support and Compliance, NINDS and NIH offices involved in communication) to integrate and ensure consistency of new/revised documents with policies.

+ Attend knowledge based activities to maintain a current clinical trial and Good Clinical Practice (GCP) knowledge base, in order to serve as an expert resource to the client in a regularly changing field.

REQUIREMENTS. The contractor must have:

+ Masters degree in Life Sciences or other related discipline; three (3) years of specialized experience plus a Bachelors degree is equivalent to a Masters degree.

+ Minimum of three (3) years of experience in a related field.

+ Expertise in the fundamentals of clinical trials.

+ Experience in a clinical research setting with protocols and clinical trials, such as protocol navigation/clinical research regulatory support or other related field (such as quality assurance monitoring; human research subject protection work).

+ Knowledge of regulatory requirements, FDA regulations (specifically IND regulations), Good Clinical Practices (GCPs), international guidelines, and other guidelines for clinical research, including the requirements of the institutional review board (IRB).

+ Knowledge of medical and research ethics, including the ability to ensure participant confidentiality and privacy.

+ Experience interacting with the FDA, IRBs, and other regulatory bodies in order to make all required regulatory submission and address questions/stipulations.

+ Experience with Contract Research Organizations (CROs) and pharmaceutical companies.

+ Experience related to clinical trial operations (e.g., development of Case Report Forms [CRFs]/electronic CRFs [eCRFs]), regulatory submission, patient scheduling and communications).

+ Experience with electronic data-management including proficiency in navigating clinical trials databases as well as other platforms including MS Excel, etc.

+ Strong communications skills, both oral and written, including the ability to convert scientific text into lay language for participant documents such as advertisements and informed consent documents.

+ Excellent analytical, organizational and time management skills.

+ Able to independently prioritize multiple tasks and projects.

+ Ability to work in a clinical research setting both independently and within a team.

+ Ability to perform project management functions, including delegation of tasks and ensuring deliverables are completed within a pre-specified timeframe.

+ Ability to read and understand complex clinical trial documents including scientific and medical terminology, and to implement the requirements of those documents.

The ideal candidate would have:

+ Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP).

+ Experience with Contract Research Organizations (CROs) and pharmaceutical companies.

+ Experience related to clinical trial operations (e.g., development of Case Report Forms [CRFs]/electronic CRFs [eCRFs]), regulatory submission, patient scheduling and communications).


Note that the phone number for our NIH branch is not listed. Due to the high volume of inquiries, we regret that we cannot accept phone calls. All qualified candidates will be contacted.

**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** ****

Kelly connects talented people to companies in need of their skills in areas including Science, Engineering, Education, Office, Contact Center, Light Industrial, and more. Were always thinking about whats next in the evolving world of work, and we help people ditch the script on old ways of thinking and embrace the value of all workstyles in the workplace. We directly employ nearly 500,000 people around the world, and we connect thousands more with work through our global network of talent suppliers and partners in our outsourcing and consulting practice.

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.
Posted: 2020-05-08 Expires: 2020-06-08

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Clinical Protocol Coordinator - NIH - Bethesda, MD

Kelly Services
Bethesda, MD 20814

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