Clinical Research Associate- Lowell, MA

SUMMARY:

Responsible for tracking all ongoing clinicals assigned to him/her. Responsible for contacting clinical trial site offices to verify or request follow-up data for all patients enrolled in the clinical protocol. Assist the Regulatory Affairs Mgr. in performing the duties of that position (such as organizing investigator’s brochures, labeling).

ESSENTIAL FUNCTIONS:

The incumbent may be required to perform all or a combination of the following essential functions as determined by business necessity.
1. Record Keeping: Set up and maintain record keeping system. Track patient follow-up schedules. Summarize and report clinical status.
2. Follow-up: Review and follow-up all patients enrolled in assigned clinical studies, through the use of the telephone and visits to hospitals and surgical offices.
3. Planning: Assist the Regulatory Affairs Supervisor and other BVSD personnel in planning clinical studies.
4. Budget: Schedule travel and assist in selecting clinical participants in such a way as to maximize the use of available funding.

NON-ESSENTIAL FUNCTIONS:

In addition to the essential functions listed above, the incumbent may be required to perform other non-essential functions. Employees are required to follow any other job-related instructions and to perform any other job-related duties requested by their supervisor.

QUALIFICATIONS:
§ College graduate, preferably in bioengineering or science discipline.
§ Associates degree with equivalent years of additional experience is acceptable.
§ Biological or medical background helpful.
§ Two to three years of clinical trials experience is required for this position.
§ Must be well-organized, self-starting, have good verbal and written communication skills.