Technical Subject Matter Expert - Blood Programs

Clinical Research Associate/Clinical Trial Monitor

The Clinical Research Associate/Clinical Trial Monitor will be located at Fort Detrick in Frederick, Maryland in support of a contract with the Office of Regulated Activities (ORA) under the U.S. Army Medical Research and Development Command (USAMRDC). ORA is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing medical products for the Warfighter. ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.

Responsibilities (listed are included but not limited to):

• Serve as a SME in the area of Blood and Blood Products, Blood Research, and other Combat Casualty Care Products or Devices to include traumatic hemorrhage, brain injury, hematology, and transfusion medicine.
• Provide top level technical expert support to WPAC and work closely with the advanced development team to support the DoD acquisition requirements for medical product development.
• Act as integral member of Integrated Product Teams (IPT) in support of medical product development and acquisition in the combat casualty care product portfolio.
• Actively involved in the review process of clinical protocols and associated clinical trial documents, various regulatory applications, DoD acquisition documentation and Food and Drug Administration (FDA) documentation.
• Perform highly specialized technical tasks including design and evaluation of non-clinical studies, clinical trial designs, review of non-clinical study reports, and technical inputs into the chemistry, manufacturing and controls of biologics, drugs and devices.
• Successfully communicate with personnel at various echelons through the use of effective interpersonal and communication skills.
• Support numerous efforts and effectively prioritize and multi-task requirements.
• Maintain current knowledge of relevant technology and industry developments.
• Participate in various meetings both internally and externally to the organization.
• Attend and participate in periodic site visits, off-site meetings and briefings, sub-working group meetings and investigator meetings.
• Participates in special projects as required.

Requirements:

• Masters' Degree in related scientific discipline; Ph.D. preferred.
• 6+ years of related experience.
• Experience in medical product development.
• Experience with various stages of FDA-regulated product development.
• US Citizen.
• Ability to obtain T1 (Public Trust) – NACI Clearance.
• Must be able to pass background and drug testing.
• Position may be flexible (remote work, hours, part-time/full-time) for the right person.

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