REGIONAL CRA

A top 10 pharmaceutical company is looking for a Regional CRA based out of the Southern Indiana/Louisville, KY area!!!

 

RESPONSIBILITES:

 

** MUST HAVE REGIONAL CRA EXPERIENCE ** -

- Delivery of high quality data according to agreed timelines and budget, ensuring adherence to international and local regulations and SOP standards.

 

- Participate in the site nomination process

 

- Assume ambassadorial role to facilitate communication between sites and line functions to increase value proposition to investigators.

 

- Facilitate preparation and collection of site level documents.

 

- Execute site initiation and training activities.

 

- Perform monitoring visits according to monitoring plan and author study monitoring reports.

 

- Manage site drug supply management.

 

- Resolve site level update of technical systems (ClinAdmin, EDC).

 

- Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).

 

- Manage recruitment implementing appropriate contingency plans as needed.

 

- Assure continual GCP, ICH and SOP compliance (Informed consent process, source data verification, AE and SAE reporting, IN, protocol, drug accountability etc.).

 

- Resolve deviations to standard by remedial action and training.

 

- Perform data query resolution process (both at Site and with Data Management).

 

- Execute site closeout activities.

 

- May act as local (or global) CRA Lead, as assigned.

 

- May act as a mentor to new associates for purposes of field training, as assigned.

 

REQUIREMENTS:

** MUST HAVE REGIONAL CRA EXPERIENCE ** -

 

- Basic medical and business knowledge.

 

- Understands and can apply knowledge of clinical trial designs to trial execution.

 

- Knowledge and experience in international standards (GCP/ICH), international (FDA, EMEA) and local regulations.

 

- Expertise in communication, managing multiple priorities and computer literacy

 

- Education: A degree in a scientific or health care discipline preferred.