Laboratory Compliance Coordinator - Surgical Critical Care Initiative - Military Veterans

at Henry M. Jackson Foundation

Bethesda, Maryland

Join the HJF Team!

HJF is seeking a Laboratory Compliance Coordinator to support the Surgical Critical Care Initiative (SC2i) located at the SC2i Office at 6720B Rockledge Drive in Bethesda, MD. This individual will also visit both Walter Reed National Military Medical Center and the Uniformed Services University in Bethesda, MD as needed. HJF provides scientific, technical, and programmatic support services to SC2i.

The Laboratory Compliance Coordinator is a member of the Regulatory and Laboratory Compliance team of the Surgical Critical Care Initiative (SC2i), a precision medicine center located at the Uniformed Services University of the Health Sciences, Bethesda, MD.

The incumbent will support the Regulatory and Laboratory Compliance team and ensure that SC2i laboratory operations conducted at the Uniformed Services University, the Walter Reed National Military Medical Center and the additional biorepository long term storage site at Surgery North remain compliant to Good Clinical Laboratory Practice guidelines and College of American Pathologists (CAP) requirements.

NOTE: As a U.S. Government contractor, all HJF employees are required to be fully vaccinated against COVID-19 by December 8, 2021. Proof of vaccination or an approved religious or medical accommodation will be required.

Responsibilities:
  1. Monitor Laboratory Compliance of the SC2i Quality Management Plan (QMP) and quality policies at USU-WR Surgery. (30%)
  2. Assist in reviewing and updating compliance policies and procedures as necessary. (20%)
  3. Assist in the identification of areas of compliance vulnerability and develop, implement, and monitor appropriate corrective and preventive actions (CAPAs). Assist in reviewing and updating compliance policies and procedures as necessary. (15%)
  4. Support the development, revision, and dissemination of laboratory procedures consistent with industry best practices. Standard Operating Procedure (SOP) development and implementation for both site and consortium. (15%)
  5. Support external and internal GCLP/CAP audits of the USU-WR laboratories. (10%)
  6. Assist in evaluation of Quality Management and Compliance Plan effectiveness. (10%)
  7. May perform other duties and responsibilities as assigned or directed by the supervisor. This may include attendance of and participation in required training for role.

Required Knowledge, Skills and Abilities: Experience in clinical research management, clinical trials, and cellular molecular biology (basic). Knowledge of standards such as ISO 9001, 13485, 17025, 21CFR820, 45CFR46, and ICH guidelines. Excellent communication and writing skills, interpersonal and organizational skills; must be a self-starter and be able to work independently; must be able to multi-task; ability to utilize computer applications packages, such as MS Word, Excel, PowerPoint, Access, FileMaker, Adobe Acrobat Pro, and E-mail.

Minimum Education: Bachelor's degree required for this position.

Minimum Experience/ Training Requirements: Minimum of 3-5 years of experience required for this position.

Work Environment: This position takes place in a typical office setting.

Work Arrangement: Hybrid; 3 days telework, 2 on-site.

Background/Security:Eligibility to obtain and maintain a Tier I investigation/Public Trust and a Common Access Card (CAC).

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.

Any qualifications to be considered as equivalents, in lieu of stated minimums, require the prior approval of the Chief Human Resources Officer.

Bethesda, Maryland

The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) is a global organization dedicated to advancing military medical research. 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.

The not-for-profit Foundation is authorized by Congress to support research at the Uniformed Services University of the Health Sciences (USU) and throughout military medicine. Since its founding in 1983, HJF has served as a vital link between the military medical community and its federal and private partners. The Foundation’s support and administrative capabilities allow military medical researchers and clinicians to maintain their scientific focus and to accomplish their research goals effectively and efficiently.

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