Supports Clinical Research Associates with site start-up, maintenance, and close-out activities; creates and maintains regulatory and subject binders; performs quality control of study documents for GDP and regulatory compliance; manages study supplies; prepares documentation, reports, and presentations; coordinates meetings and distributes minutes; provides on-site visit support and other incidental duties.
Job Title: Coordinator, Clinical Affairs
Supervisor/Manager Title: Director, Clinical Affairs
Job Description Summary: Supports Clinical Research Associates (CRAs) to manage specific activities related to clinical projects.
Job Responsibilities:- Participate in site start-up, maintenance, and close-out activities (e.g. tracking site progress, creating regulatory and subject binders, investigate discrepancies, etc.)
- Provides support to CRAs who are conducting site visits, as needed.
- Serves as quality control for study-related documents and is accountable for content accuracy to ensure compliance with GDP, US and OUS regulations, and internal company procedures
- Maintains organization, preparation and ordering of supplies required for clinical studies.
- Provides support to CRAs for preparing documentation, reports, and presentations.
- Coordinates study-related meetings, as needed.
- Minute taker and distributor
- Other incidental duties
- Requires a Bachelor’s degree in related field
- High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently.
- Good computer skills in usage of MS Office Suite
- Strict attention to detail
- Good written and verbal communication skills
- Must be able to work in a team environment
- Adhere to all company rules and requirements
JenaValve Technology Irvine, California, USA Office
4 Cromwell, Suite 100, Irvine, CA, United States, 92618
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