San Francisco Bay Area, CA
Senior Clinical Research Associate
Sunnyvale, CA, US
The Senior Clinical Research Associate is a in-house based position that manages clinical studies by effectively coordinating the activities of study coordinators and teams ensuring compliance with study protocols, all applicable regulations and overall clinical objectives.
- Managing Study Master Files to assure quality of the documentation files and compliance with SOPs, GCP and ICH Guidelines.
- Collecting contracts, requesting/collecting relevant investigator/site documentation (i.e. Regulatory Docs, FDF, CV/ML).
- Develop, review and process core study documents thru document control document control process and relevant departmental processes, in support of study start-up and maintenance.
- Assist study teams with study start-up (e.g site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study.
- Ensure all regulatory documents and study supplies are maintained during the lifecycle of assigned clinical trials.
- Prepare and review of various study related tracking sheets to determine and report status of clinical trial documents (distribution, status, retrieval of such documents as protocol, IB, etc.)
- Perform budget negotiations and/or interact with internal legal team, as needed.
- Participate in the study budget process and invoice tracking for 3rd party CROs, Vendors, Consultants and Clinical Sites.
- Act as primary liaison for assigned CROs and Vendors to convey project information, answer questions and resolve issues in accordance with relevant study procedures.
- Comply with ICH/GCP guidelines, GDPR and patient data protection laws, applicable SOPs and Process Guidelines, and study requirements.
- Attend Investigator Meetings and study-specific training for assigned trials.
- Help mentor and develop new and junior team members.
- Perform other duties as needed.
- Bachelor’s Degree required
- 5+ years with clinical research experience at a medical device company.
- Must have at least 2-3 years of experience with inspection readiness.
- Have a strong attention to detail and ability to solve problems and clearly communicate issues.
- Ability to take initiative, be adaptable, and strive in a dynamic environment.
- Ability to work on multiple projects and multitask.
- Ability to work independently and as a team member.
- Positive and energetic attitude.
- Be flexible to travel up to 10-15%.