Protocol Navigator Iii - Nhlbi (Remote)

Protocol Navigator III - NHLBI (remote)

Job ID: req3979
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.

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 of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRPD’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. 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. For the scientific advancement of clinical research, CMRPD services include comprehensive clinical trials monitoring, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. 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.

The Clinical Monitoring Research Program Directorate (CMRPD) provides investigators and other research staff with direct support for the development of National Heart, Lung, and Blood Institute (NHLBI) intramural clinical research protocols consistent with policies that govern human subject’s research.

KEY ROLES/RESPONSIBILITIES 

• Coordinates meetings with investigators and other key clinical research staff to identify required regulatory support
• Works directly with investigators and study team members on the development and revision of clinical research protocols and Informed Consent Forms (ICFs), and facilitates the activities of writing and regulatory review with bi-directional dialogue and feedback
• Assists the research study team with the preparation and serial submissions of Investigational New Drug (IND)/Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA)
• Facilitates the review process to obtain required regulatory, scientific and administrative approvals to initiate intramural research
• Coordinates with investigators and study team members to ensure stipulations from approving bodies (Scientific Review Committee, FDA, Institutional Review Board (IRB) and Radiation Safety Committee (RSC)) are addressed in a timely manner
• Tracks and provides assistance to prepare and submit protocol lifecycle requirement e.g., continuing review applications, ethics clearance submissions, protocol modification applications, applicable Data Safety Monitoring Board [DSMB] reports, FDA Annual Reports and FDA Change-In-Protocol submissions)
• Communicates as needed with off-site investigators and multi-center sites to ensure timely communication flow, reporting, and compliance with regulatory requirements
• Ensures activities are conducted in a timely manner and in accordance with NIH and NHLBI policies and guidelines, as well as applicable IND/IDE regulatory guidelines
• Facilitates the translation process of ICFs and protocol related documents and tracks the translated documents for internal version control
• Assists research staff in navigating research collaboration requirements (e.g. Reliance Agreement, Material Transfer Agreements (MTAs), Research Collaboration Agreements (RCAs)) and processes
• Maintains up-to-date record of completed tasks for client and Leidos Biomed/CMRPD reporting
• Ensures that training records, CVs, and licenses for all research staff listed on the delegation of authority log are complete, current, and filed in the regulatory file, as applicable
• Maintains study regulatory binders and interacts with internal as well as external monitors and auditors to ensure all regulatory documents are complete, up-to-date
• Attends regular virtual research study team meetings to discuss regulatory and reporting requirements/issues
• Keeps current with the latest developments in human subjects’ research protection regulations and bioethics policies, informing NHLBI staff, as applicable
• This position is remote with minimal travel to the NIH Clinical Center in Bethesda, Maryland

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 five (5) years of progressively responsible experience in biomedical research
  • Including four (4) years directly related to overseeing multiple concurrent trials
• Must be proficient in all functions of clinical research implementation processes and conduct
• Ability to work in a clinical research setting with multiple teams independently and within a team to facilitate efficient completion of study tasks. Knowledge of current regulatory requirements and guidelines for facilitating clinical human subjects research (including Department of Health and Human Services [DHHS] regulations)
• Experience with protocol and informed consent document development and preparation and the required approvals and documentations from inception to completion of a study
• Must be detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects while establishing timelines, tracking milestones, and dealing with shifting priorities
• Ability to submit quality documents under tight deadlines
• Proficiency in Microsoft Office
• Ability to communicate effectively, orally and in writing, with non-technical and technical staff
• Ability to obtain and maintain a security clearance

PREFERRED QUALIFICATIONS

Candidates with these desired skills will be given preferential consideration:

• 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
• Heart, Lung, and Blood disease research experience
• Knowledge of International Conference on Harmonization/Good Clinical Practices and DHHS regulations
• Knowledge of clinical trial design
• Navigation of protocol life cycle experience
• Knowledge of eCTD submissions to the FDA

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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