Join the HJF Team!
HJF is seeking a Lead Clinical Research Manager (PAIVED) to support the Infectious Disease Clinical Research Program (IDCRP) located in Rockville, MD. HJF provides scientific, technical and programmatic support services to IDCRP.
This position participates as a senior team member of the Infectious Disease Clinical Research Program (IDCRP) supporting the acute respiratory infections (ARI) research area, namely IDCRP-87-9915 Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD (PAIVED).
The Lead CRM will play a central planning and coordinating role in the implementation and management of clinical research protocols at existing and prospective IDCRP research sites and will oversee all PAIVED clinical operation-related activities at MTFs within the Department of Defense medical treatment facilities (MTFs) network in the US and abroad.
As the primary protocol operations and resource manager for PAIVED, the Lead Clinical Research Manager:
- Interacts regularly with clinical investigators, clinical site managers and coordinators, regulatory and safety monitoring staff, laboratory personnel, data coordination center personnel, data analysts, biostatisticians, program chiefs, program managers and administrative staff.
- Is responsible for resource planning, administrative oversight, asset management and research execution at IDCRP start-up sites in the US and abroad. Focuses on setting sound operational, financial and regulatory foundations.
- Provides technical advice to senior leaders on issues of manpower utilization, work flow, operational efficiency and productivity. Identifies operational challenges and their solutions.
- Serves as senior clinical research manager (CRM) and deputy to the ARI research area director.
- Conducts site feasibility studies.
- Is adept at change management.
- Effectively delegates to and supervises protocol-specific tasks of study personnel.
- Has formal supervisory duties (e.g., approval of time, training, etc.).
- Assists with the execution of analysis plans for primary and secondary study objectives.
- Responsible for development/tracking of protocol performance metrics.
- Coordinates with program managers of the IDCRP Program Coordination Center to prepare grant/funding applications, develop contracts with vendors, write progress reports for sponsors, contributes to the development and modifications of study budgets and is responsible for budget compliance, and track various aspects of the program related to research administration (e.g., personnel management, development and oversight of project budgets, etc.).
- Reviews new concepts, protocols and sub-studies and assists in the selection of appropriate study design, and is delegated with other Research Area portfolio responsibilities/tasks as appropriate.
- Works independently with little to no direction from lead researcher(s).
- Other duties as required.
Required Knowledge, Skills, and Abilities:
- Knowledge of federal and local regulations and policies pertinent to research involving human subjects.
- Clinical research professional with extensive experience in managing multi-site clinical trials/protocols, from start up to close out, and mentoring/ supervising clinical research personnel.
- Proficiency in developing operations budgets and contracting temporary clinical staff.
- Must be an independent, a self-starter, with experience conducting site assessments, developing manpower and workflow plans, and operationalizing and implementing clinical protocols at new sites.
- Expertise in rapidly developing new professional relationships in order to obtain Key Stakeholder, IRB, site, and clinic approvals in a timely manner.
- Exceptional attention to detail and organizational skills necessary to manage administrative aspects of DoD Research studies.
- Resilience under pressure as demonstrated through efficiently onboarding and training new research personnel, completing and managing study documents, and developing feasible study timelines.
- Ability to travel to Military Treatment Facilities (MTFs) to develop key site relationships, obtain study document signatures, attend/present at MTF leadership briefings as applicable, as well as onboard and train new study staff. Travel may range up to 60% depending on the study phase, with increased travel occurring during the study start-up phase.
- 2+ years “exposure” conducting health science research in the DoD or USG (essential).
- Experience in the design and conduct of clinical trials and epidemiologic studies.
- Prior experience in a clinical research environment.
- Knowledge of biomedical sciences and clinical research.
- Familiarity with clinical research methods, including studies utilizing randomized controlled trial, cohort, case- control, and case-series designs.
- Experience with utilization of electronic medical records preferred.
- Background in microbiology and infectious disease epidemiology preferred.
- Prior supervision, training, and mentorship of study personnel preferred.
- Knowledge of PCs including MS Word, Excel, and PowerPoint.
- Ability to use and train others on project management software.
- Ability to communicate effectively in written and oral form.
- Excellent verbal, written and interpersonal skills.
- Ability to effectively communicate research findings in presentations and publications.
- Ability to establish goals and agendas.
- Prior presentation and publication record preferred.
- 2+ years of experience with DoD IRB and DoD research agreement requirements (preferred).
- Occasional travel may be required.
Minimum Education/Training Requirements: Master’s degree in Epidemiology, Public Health or related field; Professional CCRC and CCRP certification (preferred).
Minimum Experience: 6 or more years of clinical research experience, including at least 5 years in a clinical research management position; educational experience (RN, MPH, or similar) may substitute for a portion of this.
Supervisory Responsibilities/Controls: Prior supervisory and mentoring experience preferred.
Background: Must be able to obtain a Department of Defense Common Access Card. This process includes a background investigation that consists of a Federal Bureau of Investigation (FBI) fingerprint check and a National Agency Check with Written Inquiries (NACI) check.
Employment with HJF is contingent upon successful completion of a background check, which may include, but is not limited to, contacting your professional references, verification of previous employment, addresses, education, and credentials, a criminal background check, drug screening, and a department of motor vehicle (DMV) check.
HJF is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.