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Clinical Research Protocol Specialist
4 months ago
Clinical Research Protocol Specialist
Job ID: req3939
Employee Type: exempt full-time
Division: Clinical Monitoring Research Program
Facility: Rockville: Fishers Ln
Location: 5601 Fishers Ln, Rockville, MD 20852 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.
PROGRAM DESCRIPTION
Within Leidos Biomedical Research Inc., the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives. CMRPD’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health (NIH) researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects.. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRPD’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale.
This position in the CMRPD/Regulatory Compliance and Human Subjects Protection Program (RCHSPP) provides protocol navigation support to the National Institute of Allergy and Infectious Diseases (NIAID) Intramural Clinical Research Community, Division of Clinical Research (DCR), Office of Clinical Research Policy and Regulatory Oversight (OCRPRO).
KEY ROLES/RESPONSIBILITIES
As part of the Protocol Navigation/Protocol Development Program (PN/PDP), the Protocol Navigator II:
- Provides protocol development and implementation support for NIAID intramural research protocols conducted domestically and internationally
- Serves as the point-of-contact and project manager for an assigned portfolio of projects
- Orchestrates meetings with Principal Investigators (PIs) and other key research staff to identify the level of support needed, creating timelines and managing protocol start-up logistics
- Works directly with PIs and Medical Writers (MWs) 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
- Ensures activities are conducted in a logical and timely manner and in accordance with policies and guidelines
- Assists research staff in navigating requirements for protocol approval: completes submissions to approving bodies (e.g., scientific review, IRB, and radiation safety), coordinates with PIs and MWs to ensure stipulations are addressed appropriately and on-time, and tracks the required approvals necessary to initiate intramural research
- Provides advice and assistance in troubleshooting human subjects protection issues
- Works closely 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 PN/PDP team members
- Collaborates and communicates with other divisions and individuals (Regulatory Affairs, the Clinical Safety Office and site monitors) to: identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities, ensure protocol design safety issues are identified early, ensure required oversight is initiated and outlined in the protocol
- Performs work independently under the general guidance of the supervisor
- Attends virtual and in-person meetings at the NIH campus in Bethesda, Maryland
- This position is located in Rockville, Maryland. Remote work is possible
BASIC QUALIFICATIONS
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below:
- Possession of Bachelor’s degree in a field related to biomedical research, clinical trials, health from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) or four (4) years relevant experience in lieu of degree. Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of two (2) years of progressively responsible experience in biomedical research, including a minimum of one (1) year directly related to overseeing multiple concurrent projects/protocols
- Must be proficient in regulatory and human subjects protection standards related to clinical research development and initiation of protocols at clinical sites
- Knowledge of regulatory requirements and guidelines for facilitating clinical human subjects research, including Health and Human Services (HHS) regulations
- Familiarity with protocol and informed consent documents, and approvals needed to initiate a study
- Ability to work in a clinical research regulatory setting, both independently and within a team, to coordinate, negotiate and facilitate the program goals
- Ability to independently assess project needs, mitigate potential pitfalls, confer with experts, and communicate and initiate a plan of action
- Strong collaborative skills with ability to build relationships within multiple groups
- Must be detail-oriented and possess substantial organizational skills
- Ability to exercise sound judgment in prioritizing multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
- Ability to submit high quality deliverables in a professional environment under tight deadlines
- Ability to communicate effectively, orally and in writing, with non-technical and technical staff
- Proficiency in Microsoft Word including proficiency with track changes, MS Office
- Ability to obtain and maintain a security clearance
PREFERRED QUALIFICATIONS
Candidates with these desired skills will be given preferential consideration:
- Familiarity with therapeutic area of allergy and infectious diseases
- Previous study coordination and/or project management experience in clinical research
- Registered Nurse (RN)
Commitment to Diversity
All qualified applicants will receive consideration for employment without regard to sex, race, ethnicity, age, national origin, citizenship, religion, physical or mental disability, medical condition, genetic information, pregnancy, family structure, marital status, ancestry, domestic partner status, sexual orientation, gender identity or expression, veteran or military status, or any other basis prohibited by law. Leidos will also consider for employment qualified applicants with criminal histories consistent with relevant laws.
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