Clinical Research Evaluation Supervisor

7 days left

Location
Silver Spring, MD
Posted
Mar 15, 2017
Closes
Apr 04, 2017
Industry
Research
Hours
Full Time
This position (Clinical Research Evaluation Unit Supervisor) is in support of the Department of Laboratory Diagnostics and Monitoring for the Military HIV Research Program.  

 

Responsibilities include, but are not limited to the following:

 

Manage, coordinate and execute clinical testing of sexually transmitted infections, blood borne infections and transfusion transmissible infections in support of clinical laboratory mission and research studies.

 

Oversight of US FDA Pre-Market Clinical Trials and other IRB approved clinical trials and non-clinical studies.

 

Support IRB submissions

 

Support development of Cooperative Research and Development Agreements (CRADAs) and Material Transfer Agreements (MTAs)

 

Provide support for internal, manufacturer (sponsor), CAP, and/or US FDA 483 regulatory audits

 

Serve as point of contact for manufacturer and sponsor study coordinators.

 

Provide regular project updates to Principal Investigators.

 

  

  Education Master's degree in Health or science related discipline

Qualifications 5 years of related experience including oversight of clinical trials.

 

  As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.