Laboratory Compliance Coordinator - The Henry M. Jackson Foundation for the Advancement of Military Medicine
Bethesda, MD 20817-0000
About the Job
Join the HJF Team!
HJF is seeking a Laboratory Compliance Coordinator to assist in the compliance of HJF research programs with applicable Laboratory Compliance standards. The incumbent will support the Regulatory and Laboratory Compliance team and ensures that SC2i laboratory operations conducted at the Walter Reed National Military Medical Center and the Clinical Testing laboratory/biorepository at Surgery North (HJF headquarters) remain compliant with Good Clinical Laboratory Practice guidelines and College of American Pathologists (CAP) requirements.
This position will be in support of the Surgical Critical Care Initiative (SC2i). The Surgical Critical Care Initiative (SC2i), funded by the Department of Defense was established in 2013. SC2i is a Uniformed Services University center that leverages legacy information from service members, and critically ill civilian and military patients to develop biomarker-driven clinical decision support tools (CDSTs) with the goal of improving patient clinical outcomes and reducing costs across the injury/disease cycle.
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.
Responsibilities:- Monitor laboratory compliance with the SC2i Quality Management Plan (QMP) and quality policies at SC2i laboratories.
- Review and update compliance policies and procedures as needed.
- Identify areas of compliance vulnerability and develop, implement, and monitor appropriate corrective and preventive actions (CAPAs).
- Support the development, revision, and dissemination of laboratory procedures in alignment with industry best practices, including Standard Operating Procedure (SOP) development and implementation for both site and consortium.
- Support external and internal GCLP/CAP and CLIA/CLIP audits of SC2i laboratories.
- Assist in evaluating the effectiveness of the Quality Management and Compliance Plan.
- Perform other duties and responsibilities as assigned or directed by the supervisor, including attendance at and participation in required role-related training.
Education and Experience
- Bachelor’s Degree is required.
- Minimum of 3-5 years of experience required.
Required Knowledge, Skills and Abilities
- Knowledge of Good Clinical Laboratory Practice (GCLP) guidelines.
- Basic knowledge of the College of American Pathologists (CAP) Biorepository Accreditation Program and CAP Laboratory Accreditation Program.
- Basic understanding of CLIA/CLIP requirements.
- Experience and foundational knowledge in molecular biology, along with basic laboratory experience.
- Strong communication, writing, interpersonal, and organizational skills.
- Must be a self-starter, capable of working independently and multitasking effectively.
- Proficient in using computer applications, including MS Word, MS Excel, MS PowerPoint, MS Teams, Adobe Acrobat Pro, Google Drive, Google Meet, Google Docs, Zoom, and email platforms.
- Due to site requirements this position requires U.S. Citizenship as well as the ability to obtain and maintain a T1 Public Trust with CAC.
Physical Capabilities
- Ability to stand or sit at a computer for prolonged periods.
Work Environment
- This position will take place primarily in an office setting.
Compensation
- The annual salary range for this position is $64,200-$80,000. Actual salary will be determined based on experience, education, etc.
Benefits
- HJF offers a comprehensive suite of benefits focused on your health and well-being, from medical, dental, and vision coverage to health savings and retirement plans, and more.
Some HJF employees are required to be fully vaccinated against COVID-19. Proof of vaccination or an approved religious or medical accommodation may 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.