Clinical Trials Medical Advisor & SME

Kapili Services, LLC; Frederick (MD); Presencial; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

Bering-Alaka`ina Holdings, LLC is seeking a Medical Advisor Support Specialist to provide expert clinical and regulatory support for our government customer at Fort Detrick, MD.

The role covers medical devices, diagnostics, drugs and biologics, site selection, protocol development, and collaboration across IPTs to ensure compliant trial execution.

Candidates should have a medical degree and at least four years of relevant experience, with the ability to navigate DoD and FDA requirements.

Formación

• Minimum four years of relevant experience.
• Expertise in medical devices, diagnostics, drugs, biologics, or other medical countermeasures.
• Expertise in developing the research strategy for clinical trials.
• Experience with site selection, site set-up, and subject recruitment/retention.
• Expertise in pharmaceutical quality/CMC.
• Knowledge of DoD acquisition processes related to clinical problems.

Responsabilidades

• Provide medical advisory support across clinical trial planning and execution.
• Assist in developing clinical protocols and trial documents.
• Provide SME input on regulatory strategy with DoD and DHA.
• Collaborate on site investigator selection and staff training issues.
• Support regulatory compliance with FDA and DoD requirements.
• Participate in IPT meetings, site visits, and program briefings.
• Review technical documents and regulatory submissions as requested.
• Provide expert reviews for preclinical/clinical data and publications.

Conocimientos

Medical devices

Clinical trials

Regulatory affairs

CMC knowledge

DoD processes

Site recruitment

Educación

Medical degree or equivalent

Descripción del empleo

Bering-Alaka`ina Holdings, LLC is seeking a Medical Advisor Support Specialist to provide expert clinical and regulatory support for our government customer at Fort Detrick, MD.

The role covers medical devices, diagnostics, drugs and biologics, site selection, protocol development, and collaboration across IPTs to ensure compliant trial execution.

Candidates should have a medical degree and at least four years of relevant experience, with the ability to navigate DoD and FDA requirements.