Address
Form of work
SalaryOverview:
Design, plan and conduct Clinical Research trials by effectively coordinating the activities of study coordinators and investigators and by ensuring compliance with study protocols, FDA and International regulations, IRB and/or Ethics committees requirements and overall clinical objectives.
Responsibilities: - Under the direction of the Director, Clinical Affairs, implement Clinical Research projects.
- Oversee patient screening and enrollment at assigned clinical study sites.
- Monitor ongoing compliance to study protocols.
- Work with investigators to quickly and effectively resolve discrepancies.
- Review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation.
- Perform site training to ensure compliance to the Investigation Plan.
- Develop materials for clinical training sessions.
- Coordinate meetings with site coordinators and investigators.
- Identify and prepare written reports as required.
- Ensure accurate inventory of investigative devices.
- Regularly recognize problems and recommend corrective and preventive action.
- Supports development of the Design and Process FMEA.
- Identifies hazards and mitigating risk associated with identified hazards in Design and Process FMEA and determining severity of the harms associated with identified hazards.
- Evaluates product history data based on customer complaint records, results of controlled investigations and published literature for the device or similar devices, if applicable.
- Attend relevant scientific and/or medical meetings.
- 30 to 50% travel.
- Normally receives no instructions on routine work, general instructions on new assignments.
- Perform other duries as assigned by supervisor
- Knowledge of FDA regulatory requirements related to the conduct of clinical studies.
- Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
- Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Education:
- Bachelors degree in a scientific discipline, RN or BSN degree or equivalent
Experience:
- Minimum of 3 years experience with a Clinical trial
- Experience with Medical Devices is preferred
Compensation:
$65K-$95K
