NIH Hierarchy:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Roles/Responsibilities:
- Establish, implement and maintain standardized processes and assess performance to make recommendations for improvement.
- Develop and maintain progress tracking systems for action items and follow up to ensure timely reply or action.
- Prepare technical reports, abstracts, presentations and program correspondence concerning assigned projects through research and analysis of information relevant to government policy, regulations and other relevant data and monitor all assigned programs for compliance.
- Provide project management support with planning and development of project schedules and deliverables, tracking project milestones, managing timelines, preparing status reports and monitoring progress ensuring adherence to deadlines.
- Recommend corrective plans to alleviate significant deviations from research priorities, protocols, staffing, budgets and schedules.
- Communicate with protocol regulatory bodies including the IRB and facilitate communication among the collaborating groups.
- Facilitate communication through all levels of staff by functioning as a liaison between internal departments, senior management, and the customer.
- Serve as leader/mentor to administrative staff and prepare employee performance evaluations.
- Serve as the central contact with users for all questions and problems related to program administration and collaborations as they relate to clinical research projects related to the ongoing work scope.
- Attend weekly meetings to discuss upcoming events, tasks, special projects and implementation plans.
- Develop and implement procedures/programs to ensure effective and efficient business and operational processes.
- Identify potential bottlenecks in the upcoming development process and work with all team members and senior management to resolve them.
- Manage clinical research activities including those pertaining to laboratory and clinical activities, regulatory compliance and clinical trials management (domestic, international, DoD), international collaborations, biostatistician support and biodefense initiatives including logistical details surrounding these projects.
- Manage clinical and translational projects through the interaction with the junior clinical investigators, clinical trials program specialist, clinical trials study coordinator, and data management center.
- Monitor adherence to federal regulations as they relate to protocol development and implementation.
- Provide assistance in measuring, monitoring, problem solving, and reporting of research, operational and business issues.
- Track, plan and implement monitoring/regulatory projects associated with government clinical protocols.
- Have significant responsibility for safety surveillance, providing medical leadership for the safety oversight of study products (e.g., biologics, diagnostics and devices) including investigational drug safety, data and safety monitoring, serving as the Sponsor representative on safety oversight committees, and related CCR activities.
- Work closely with study teams, government customer, and the OSRO regulatory and monitoring groups to facilitate timely, complete, accurate, and informative adverse event reporting to the 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. Ensures, in conjunction with the OSRO, compliance with regulatory reporting requirements for safety reporting in clinical trials.
- 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 (SAE) reports 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.
- Oversees the collection and reporting of adverse events and SAE’s and compliance with SAEs for regulatory reporting requirements, including the reconciliation of SAE data for IND annual reports.
- 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.
- Provides representation and coverage for 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 of the CCR OSRO.
- Responsible for the management and specifically the oversight of scientific/medical contributions of the CCR OSRO and all pharmacovigilance activities including managing the review of draft protocols, informed consents and other protocol documents.
- As needed or in collaboration with other medical monitors, reviews and interprets clinical data on a real-time basis in collaboration with the Principal Investigator (PI) or Data Management Center, if applicable, to determine the safety of the study product being evaluated.
- Collaborates with senior managers within the CCR Office of the Clinical Director, Office of Sponsor and Regulatory Oversight , and CCR Principal Investigators in the implementation and execution of the protocol development and execution.
Minimum Requirements:
- A Doctorate of Medicine (M.D.) degree, preferred to have advanced education in a field related to biomedical research or oncology.
- Minimum seven (7) years of relevant experience in clinical research, medical affairs, drug safety within the pharmaceutical industry or Government equivalent.
- Knowledge of pharmacovigilance, FDA and International clinical safety regulations and guidelines, and clinical research trials methodology, design, implementation and analysis.
- Must have experience managing complex programs or large production units.
- Knowledge of FDA regulations, International Counsel on Harmonization (ICH) GCP guidelines, the DHHS Office of Human Research Protections (OHRP) regulations, NIH policies pertaining to clinical research, and clinical trials research and management.
- Preferably understanding of other international regulations for drug safety evaluations. and working knowledge of MedDRA.
Location:
- Candidates residing in the DC / Baltimore metro area is preferred.
- Remote / telework candidates may be considered but candidates must be willing to travel to the NIH’s main campus in the DC metro area at their own expense, approximately six (6) times a year (approximately every two months), for a 1 to 2 day duration, at dates dictated by NCI. Candidates may be required to travel to NIH at their own expense for several days during their first week of employment. For remote/telework candidates, it is preferred that candidates reside within a 4-hour drive or 3-hour train ride.
