Clinical Trial Administrator

Employer
AGTC
Location
Alachua, Florida
Posted
Nov 02, 2017
Required Education
Bachelors Degree
Position Type
Full time

Applied Genetic Technologies Corporation (AGTC) is a clinical stage biotechnology company dedicated to developing novel gene therapies for ophthalmic diseases. AGTC is aggressively expanding and seeks a full-time Clinical Trial Administrator.

Reporting Relationship:

  • The Clinical Trial Administrator will report directly to the Chief Medical Officer.

Responsibilities:

Job responsibilities will include, but are not limited to, the following.

  • Serves as a member of the project team with the goal to contribute towards efficient management of clinical trials and as an office based secondary point of contact for sites during the course of the study in addition to providing phone coverage for travelling team members.
  • Assists Clinical Trial Managers in the production of study reports and updates.
  • Manages inventories for clinical trials supplies, including the tracking and shipment of investigational product.
  • Assists the project team with preparation and distribution of Clinical Trial documentation including; Manual of Procedures, Investigator Site Files, Pharmacy Manuals, Informed Consent Forms, Investigator Brochures and Protocols.
  • Develops and maintains the study specific investigator database.
  • Facilitates the study documents printing process, as applicable.
  • Develops and maintains good working relationships with investigators and study staff to promote AGTC’s high quality and ethical image.
  • Facilitates project meetings with respect to the preparation and distribution of materials and final meeting minutes, as well as the coordination of participants.
  • Assists with corporate administration activities according to need and availability.
  • Sets-up and maintain the Trial Master File in compliance with ICH GCP and AGTC SOPs and as per the Clinical Trial Manager guidance.
  • Liaise with AGTC departments/affiliates ensuring all study documentation is filed appropriately.

Requirements:

The successful candidate will meet the following requirements.

  • Bachelor’s degree (life sciences/health care field is a plus), or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities with a minimum of 2 years’ experience in clinical research.
  • Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements.

AGTC offers competitive compensation commensurate with education and experience.  AGTC is an EOE and maintains a drug-free workplace. Please click "Apply" or send CV or resume to:

Human Resources

Applied Genetic Technologies Corporation

14193 NW 119th Terrace, Suite #10

Alachua, FL 32615