Laboratory Director - Hybrid (FT)
Full Time
Bethesda, MD 20889
Posted
Job description
Join the HJF Team!
The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
HJF is seeking a
Head of Laboratory/Repository Operations to support of the Department of Preventive Medicine and Biostatistics, The F. Edward Hébert School of Medicine, Uniformed Services University (USU), Infectous Disease Clinical Research Program (IDCRP) located in Bethesda, MD. They will be responsible for oversight and coordination of lab and repository-related protocol operations, quality management, and institutional liaison in support of the Infectious Disease Clinical Research Program (IDCRP) at the Uniformed Services University (USU). The incumbent is also responsible for oversight and advancement of optimization, standardization, and documentation of related clinical research processes and will provide expertise and guidance to IDCRP clinical research study teams for single and multicenter clinical study protocols, including FDA-regulated clinical trials. Also serves as Laboratory Manager to oversee an IDCRP lab in collaboration with one or more senior technicians or other staff handling most day to day management responsibilities. Supervised by the IDCRP Director, Center Operations.
Responsibilities:
- Oversees, leads, and ensures capabilities, efficiency, quality, and effectiveness of lab and repository-related protocol operations across the IDCRP, including standardization, documentation , preparation, and coordination execution of protocol-related lab/repository processes and quality assurance.
- Serves as an IDCRP Laboratory and Repository Senior Manager to oversee lab operations; works in collaboration with one or more senior technicians or other staff handling most day to day lab management responsibilities. Responsibilities include oversight of IDCRP and collaborating repository sites’ processing and storage, inventory and data provision, incoming and outgoing shipments, and QA; collaboration with IDCRP DCC to enhance specimen tracking and availability of inventory data with protocol data sets; and review of all protocols prior to SRB submission and site initiation to ensure appropriate lab and repository logistics, processes, and documentation; also oversees PCC and sites’ lab-related supply needs are met.
- Coordinates with other IDCRP component heads (Clinical Research Management, Data Operations, Quality Management/Regulatory Affairs, Site Operations, Program Management), protocol teams, and others to ensure effective research support, protocol execution, and lab/repository-related logistics.
- Provides expert guidance and input to Directors, Principal Investigators, component heads, and protocol teams regarding protocol design and efficiency, resource requirements, staffing, and other aspects of laboratory and repository-related clinical research operations.
- Oversees, identifies needs for, and ensures development, maintenance, availability, and training of site-related lab/repository-related research operations standard operating procedures (SOPs) and protocol-specific laboratory manuals of operations (LMOPs).
- Trains, and mentors junior staff to ensure and enhance their competence and effectiveness. Coordinates closely with other IDCRP laboratory staff, e.g. technicians, repository managers, their supervisors, and others as appropriate. May also provide advice and training to other Program staff; may directly supervise laboratory and other staff when appropriate.
- Travels to clinical study sites and participates in IDCRP, regulatory, scientific, and other meetings or trainings as required.
Required Knowledge, Skills and Abilities:
- Experience overseeing Operations of a large group, facility or laboratory.
- Prior experience as an Associate Lab Director or Manager that includes implementation of sponsored clinical trials.
- Extensive knowledge of laboratory and BioRepository operations to include specimen processing, shipping, and archival storage to protect sample integrity and to meet all regulatory and protocol requirements.
- In-depth knowledge of all aspects of processing blood and conforming to pre-analytical test requirements for serum, plasma, whole blood, PBMC and other clinical specimens.
- Good knowledge of GCLP, IATA, CAP and CLIA requirements.
- Excellent laboratory, technical and management skills.
Supervisory Responsibilities
- Direct Supervisor: Direct authority to make decisions on the following: employee hiring, disciplinary action, starting salaries and merit increases; conduct employee performance evaluations and directs work activities.
Physical Capabilities
- Ability to stand or sit at a computer for prolonged periods.
Qualifications:
Work Environment
- This position will take place primarily in a laboratory setting.
- This position offer a hybrid and remote option, preferably candidate local to the DC, Maryland and Virginia area.
Education and Experience
- Master's Degree.
- More than 10 years of experience.
All HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation will be required.
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, education and credentials, a criminal background check, and a department of motor vehicle (DMV) check if applicable. Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.
About Henry M. Jackson Foundation for the Advancement of Military Medicine:
HJF is a 501(c)(3) nonprofit organization dedicated to advancing military medicine. We serve military, medical, academic and government clients by administering, managing and supporting preeminent scientific programs that benefit members of the armed forces and civilians alike.Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. HJF's support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and accomplish their research goals.
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