Clinical Research Associate
2 Musick Irvine, CA 92618 US
Orange County based medical device manufacturer is hiring a Remote Sr. Clinical Research Associate.
Candidate must be located in California.
The Clinical Research Associate designs, plans and conducts 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.
- Under the direction of the Manager, 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 duties as assigned by supervisor
- Knowledge of FDA regulatory requirements related to the conduct of clinical studies.
- Experience in Cardiovascular or Peripheral medical devices
- 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
- Bachelors degree in a scientific discipline, RN or BSN degree or equivalent
- Minimum of 3 years experience with a Clinical trial
- Experience with Medical Devices is preferred
Meet Your Recruiter
As Branch Manager, Alexis Cabero focuses on identifying talent for a variety of industries including medical devices, administrative support, customer service, engineering, and human resources. Graduating from The University of California, Irvine with a B.A. in Arts and Digital Media, Alexis’ recruiting career began in 2014 while staffing for assisted living facilities, where she matched passionate healthcare professionals to provide personal non-medical care for home care clients. Alexis is passionate about helping others recognize their potential, and does so by using a thorough discovery process with her candidates to better understand what areas they excel in and providing opportunities exclusive to Marquee Staffing.
While out of office, Alexis enjoys spending her free time with family and her five dogs.