Biodefense Regulated Laboratory Scientist
Clinical Research Management - Frederick, MD

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Growing and well-respected biomedical (clinical, basic and applied) research firm has openings at USAMRIID . If you are passionate about research, and are looking for a firm that shares your passion, and provides competitive salaries with a strong benefits package, join the ClinicalRM team.

We are currently seeking a Biodefense Regulated Laboratory Scientist for the Frederick, Maryland area.

RESPONSIBILITIES:

  • Carry out regulated studies.
  • Support a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization & validation.
  • Analytical support includes HPLC analysis and pharmacokinetic analyse.
  • Develops standard operating procedures (SOPs) study-specific procedures (SSP), etc. to ensure compliance with Good Laboratory Practices (GLP) regulation.
  • Review protocols, study plans, and associated documentation to support research and development projects under GLP for products regulated by the Food and Drug Administration (FDA).
  • Organizes and tabulates laboratory records and resulting data to ensure complete study files.
  • Analyzes data and prepares reports for submission to FDA.
  • Assists investigators to ensure that PI written reports are in compliance with appropriate standards, e.g., 21 CFR regulations.
  • Assist principal investigators in developing documentation packages from laboratory studies that can support investigational and new drug applications (IND/NDA).
  • Work effort contributes to an array of FDA regulatory documents e.g., Master File, IND/IDE, NDA/PMA, 510 (k) notification.
  • Impart and shares knowledge through in-lab training and side-by-side work for the transmittal of regulatory concepts, practices, and procedures.
  • Perform laboratory quality management activities for supported customers to the required quality standard, e.g., ISO Guide 34, CLIA88, GLP.
  • Supports analytical method validation studies to support use in FDA-regulated studies.
  • Supports medical or advanced animal research, including Animal Rule Studies, by assisting GLP compliant studies of investigational specimens from these studies.
  • Supports SIP Program by assisting GLP compliant studies for potency testing of clinical research materials. Supports product release testing (potency, identity, stability) for cGMP manufactured materials.
  • Ensures that integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials.
  • Performs light duties and other related duties as required and assigned.
  • MINIMUM QUALIFICATIONS:

  • Required Experience (Number of years) at time of hire: at least 8 years’ experience in biomedical research or equivalent experience
  • Required Education or Credentials: M.S. in a biomedical science (preferred) PhD with limited experience (min 2 yrs) is acceptable, but not preferred.
  • Must be able to work independently following a brief period of specific technical training.


  • Qualified candidates will receive consideration for employment without regard to race, color, religion, sex, or national origin. Candidates for positions under ClinicalRM’s contracts with the Department of Defense (DoD) will be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency. Such investigations may include criminal records and credit history checks.

    ClinicalRM is an Affirmative Action-Equal Opportunity Employer

    www.clinicalrm.com

    “NorthCoast 99” Best Places to Work recipient

    About this company
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    ClinicalRM is a Contract Research Organization supporting government and commercial clinical research for biologics, drugs, and devices.