Laboratory technician/clinical trials assistant with documented experience in execution of US FDA Pre-Market Application (PMA) Clinical Trials in support of vaccine and therapeutic trials for HIV; STI; BBI; TTI; Leishmania; and pathogens of US Military and National interest.
Responsibilities may include the following:
Administration and management of all regulatory documentation supporting PMA trials;
Assist in the generation; receipt and filing of required study documentation; including but not limited to study logs; study binders; and regulatory documents according to applicable SOPs.
May perform assays to quantify disease progression or vaccine efficacy
May maintains reagent and consumable supplies needed to conduct laboratory experiments. Facilitates the necessary administrative and logistic processes to order and receive materials.
Prepares technical reports; summaries; and protocols. Maintains clear and accurate laboratory records; inventories and logbooks.
Bachelors degree in a scientific discipline
2 to 4 years of laboratory experience
Documented experience in execution of US FDA Pre-Market Application (PMA) Clinical Trials in support of vaccine and therapeutic 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.
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