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Clinical Research Protocol Navigator III

Employer
Frederick National Laboratory for Cancer Research
Location
Bethesda, MD
Start date
Sep 21, 2022

View more

Discipline
Clinical, Clinical Research, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital
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Job Details

Clinical Research Protocol Navigator III

Job ID: req2784
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: NIH
Location: NIH Campus 9000 Rockville Pike, Bethesda, MD 20892 USA

The Frederick National Laboratory is a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) and operated by Leidos Biomedical Research, Inc.  The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.

Accountability, Compassion, Collaboration, Dedication, Integrity and Versatility; it's the FNL way.

KEY ROLES/RESPONSIBILITIES

  • Orchestrates meetings with investigators and other key medical staff to identify required support
  • Serves as the point-of-contact and project manager for an assigned portfolio of projects
  • Works with PIs and the research team on the design, plan, production, and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents
  • Works with research staff to navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinate with PIs and the research team to ensure stipulations are addressed appropriately and on-time; track the required approvals necessary to initiate and continue intramural research
  • Prepares program actions that do not go to the IRB such as data sharing plans, reliance agreements and technology transfer agreements
  • Provides consultation and assistance to complete protocol lifecycle requirements (e.g., continuing review applications, bioethics reviews, protocol amendments, applicable Data Safety Monitoring Board [DSMB] reviews), FDA Annual Reports, regulatory binder maintenance)
  • Provides advice and assistance in troubleshooting human subjects protection issues
  • Works with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with Protocol
  • Navigation (PN) and research team members
  • Assists the research study team with Investigational New Drug (IND)/Investigational Device Exemption (IDE) development and serial submissions to the U.S. Food and Drug Administration (FDA); assists research staff in navigating requirements for special circumstances
  • Works with the Office of Human Subjects Research Protection (OHSRP) to keep abreast of new guidance related to policy governing the conduct of research at the NIH Intramural Research Program, and to share relevant information with PN and research team members
  • Educates research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer
  • Ensures activities are conducted in a timely manner and in accordance with NIH policies and guidelines, as well as applicable IND/IDE regulatory guidelines
  • Attends NIDDK’s Quality Assurance Program meetings, including site initiation visits and offers guidance regarding protocol preparation
  • Identifies and makes recommendations to improve the processes, procedures and policies of the Office and assist in issuing guidance
  • Disseminates expertise and best practices related to Human Protections in clinical re-search through presentations, publications, and/or interactions with colleagues
  • Attends meetings of various HRPP groups within NIH
  • This position is located in Bethesda, Maryland 

BASIC QUALIFICATIONS

To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:

  • Possession of a bachelor’s degree from an accredited college or university according to the Council for Higher Education Accreditation (CHEA) in a field related to biomedical research, clinical trials, health. (Additional qualifying experience may be substituted for the required education)
  • Foreign degrees must be evaluated for U.S. equivalency
  • In addition to education requirements, a minimum of five (5) years of progressively responsible experience in biomedical research, including a minimum of four (4) year directly related to overseeing multiple concurrent projects that comprise diverse functions of clinical research implementation processes and conduct
  • Must be proficient in all functions of clinical research implementation processes and conduct
  • Ability to work in a clinical research setting both independently and within a team to coordinate, negotiate, and facilitate data and ensure documents are succinct
  • Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research (including
  • Department of Health and Human Services [DHHS] regulations)
  • Familiarity with protocol and informed consent documents and approvals needed to initiate a study
  • Ability to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
  • Ability to submit quality products under tight deadlines
  • Proficiency in Microsoft Office
  • Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects
  • Ability to communicate effectively, orally and in writing, with non-technical and technical staff
  • Must be able to obtain and maintain a security clearance
  • Proficient in protocol and informed consent writing
  • Knowledge of writing and submitting an investigational new device application

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

  • Familiarity with therapeutic area of diabetes, digestive and kidney disease
  • Familiarity with FDA regulatory requirements for IND and IDE; preferably those related to investigational biologic agents regulated by the FDA, and guidelines for facilitating clinical human subjects research
  • Knowledge of International Conference on Harmonization/Good Clinical Practices and DHHS regulations
  • Knowledge of clinical trial design
  • Navigation of protocol life cycle experience

Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)

#readytowork

Company

A rewarding career with global impact

Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.

Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.

We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.

Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.

Discover why joining the Frederick National Laboratory team could be the most important career step you take

 

 

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Find Us
Website
Phone
301-846-1000
Location
8560 Progress Drive
Frederick
MD
21701
United States
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