Job ID: req4093
Employee Type: exempt part-time
Division: Clinical Monitoring Research Program
Facility: Telework: US
Location: 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., operator of the Frederick National Laboratory for Cancer Research, the Clinical Monitoring Research Program Directorate (CMRPD) provides high-quality comprehensive and strategic operational support to high-profile domestic and international clinical research initiatives sponsored by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), and several other institutes within NIH. CMRPD’s ability to provide rapid responses and high-quality solutions, and to recruit and retain experts with a variety of backgrounds, allows the directorate to facilitate strategic support to the growing clinical research portfolios of NCI, NIAID, and other NIH divisions/offices/centers. CMRPD’s support services are aligned with the program’s mission to provide comprehensive clinical trials operations and program/project management services to advance scientific clinical research that complies with applicable regulations and guidelines, maintains data integrity, and protects human subjects. CMRPD services include clinical trials monitoring, regulatory affairs support, clinical safety oversight, protocol navigation/protocol development, and programmatic and project management support to facilitate the conduct of more than 400 Phase I, II, and III domestic and international trials annually. These trials investigate the prevention, diagnosis and treatment of cancer, influenza, HIV, infectious diseases and emerging health challenges like Ebola virus and COVID-19, heart, lung, and blood disorders, parasitic infections, and rare and neglected diseases. CMRPD’s collaborative approach to clinical research support and the expertise and dedication of staff to the continuation and success of CMRPD’s mission has contributed to improving the overall standards of public health on a global scale.
The Clinical Monitoring Research Program Directorate (CMRPD) provides specialized support for initiatives and special projects in support of the National Institute of Allergy and Infectious Diseases (NIAID) Division of Clinical Research (DCR). CMRPD is responsible for the management and oversight of NIAID clinical research studies related to COVID-19 and possibly other emerging and re-emerging infectious disease studies globally. The CMRPD, Clinical Safety Office (CSO) provides comprehensive clinical safety management and oversight support to the various clinical research initiatives of the NIAID, DCR.
Key Roles/Responsibilities
- Provides broadly based regulatory, ethical, GCP and medical evaluation of key documents including protocols, informed consent documents, and investigator brochures for proposed and ongoing clinical trials, as well as related administrative activities to help ensure efficient, effective, and compliant study conduct and safety oversight of drug, vaccine, biologic, diagnostic, and device research that includes FDA investigational drug (IND) and device (IDE) safety data monitoring, review, reporting, and related RCHSPP activities
- Works closely with study teams, government customer, and the RCHSPP regulatory and monitoring groups to facilitate timely, complete, accurate, and informative adverse event reporting to other regulatory and oversight entities such as FDA and IRBs
- Performs investigational product safety reviews and participates in the preparation of technical and regulatory documents
- Acts as the Sponsor Medical Monitor of record and provides medical safety monitoring for ongoing clinical trials conducted under the OCRPRO sponsorship
- Reviews and interprets clinical data on a real-time basis, including report review, teleconferences, and other activities in collaboration with the Principal Investigator or Data Management Center, if applicable, and makes recommendations and determinations as appropriate and required to help ensure the protection of study participants
- Reviews serious adverse event reports from clinical sites to determine if an Investigational New Drug (IND) Safety Report or an Unanticipated Adverse Device Effect Safety Report is needed
- In conjunction with responsible investigator, oversees and approves the preparation of safety information for reporting to regulatory bodies
- Ensures, in conjunction with Regulatory Affairs, compliance with regulatory reporting requirements for safety reporting in domestic and international clinical trials
- Assists with preparation of INDs and IND Annual Reports as they relate to clinical safety information
- Provides expert consultation, as appropriate, to Investigators and study teams on protocol procedures related to safety and compliance with regulations and guidance, including, but not limited to, population selection criteria and screening, safety testing, pausing and halting, blinding, DSMB and other safety oversight, communication of information and risks in plain language for informed consent, toxicity table selection, and rules governing protocol evaluation and reporting of serious adverse events, unanticipated problems, lab abnormalities, subject withdrawals, in accordance with regulatory requirements
- Serves on assigned project/product teams or sub teams to provide guidance regarding safety-related issues
- Provides representation and coverage for the Director of Clinical Safety and other Medical Monitor(s) as necessary to ensure smooth function and avoid gaps in oversight, and provides consultation, expertise, and clinical leadership as appropriate for clinical and non-clinical members
- This position is remote
Basic Qualifications
To be considered for this position, you must minimally meet the knowledge, skills, and abilities listed below: - Possession of a Doctoral degree (e.g. M.D., Pharm.D.) in a field related to biomedical research or life science from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). Foreign degrees must be evaluated for U.S. equivalency
- In addition to the education requirement, a minimum of five (5) years of relevant experience in drug safety within the pharmaceutical industry, academic facility, or clinical research involving allergy, infectious diseases, or other relevant field
- and significant relevant clinical and/or clinical research experience (e.g. 6 or more years of hospital based human subjects research and/or clinical practice, e.g., in critical care, infectious diseases or immunology, emergency medicine, or similar specialized field) may be applied at the discretion of the hiring manager in satisfaction of all or part of this requirement
- Knowledge of pharmacovigilance, clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation, and analysis
- Knowledge of FDA regulations, ICH/GCP guidelines, the NIH's Office of Human Research Protections regulations, and clinical trials research and management
- Ability to communicate effectively with the Sponsor or designee, clinical study staff and RCHSPP staff
- Ability to render decisions and policy interpretations, and provide guidance and leadership in the performance of complex planning, coordination, and evaluation of duties for a clinical trial project
- Ability to independently identify problems and effectively offer solutions to problems
- Ability to comprehend, integrate and interpret scientific and medical data from a variety of sources
- Excellent written and oral communication in clinical, scientific, and regulatory areas
- Ability to obtain and maintain a security clearance
Preferred Qualifications
Candidates with these desired skills will be given preferential consideration:
- Post graduate clinical research training
- Ability to present scientific information to both technical and non-technical audiences
- Experience in computer software packages including Microsoft applications
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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