Contract – Clinical Research Associate
SF Bay, California
This position will assist in the design, planning and implementation of clinical studies including, but not limited to, coordination of clinical study activities to ensure compliance with the protocol, Good Clinical Practice (GCP), government regulations, and overall clinical objectives.
- Daily activities will vary depending on the phase of the clinical study. Receive minimal to no instructions on routine work, and general instructions on new assignments.
- Interact with the contract research organization (CRO) personnel, investigators, and study sites to ensure clinical studies are performed in compliance with the protocol, GCPs, government regulations, and overall clinical objectives.
- Coordinate key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out.
- Verify study data on source documentation and case report forms (CRFs) to ensure compliance with the study protocol, GCPs, and Standard Operating Procedures (SOPs). Identify and resolve data discrepancies.
- Conduct on-site monitoring visits as needed, including site qualification, initiation, interim, co-monitoring with CRO, and close-out visits. Prepare and review site visit reports.
- Assist in generating clinical documents including, but not limited to, informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
- Assist in the evaluation and selection of sites and CROs, and organize study meetings (investigator meeting, steering committee meeting, CRO kick-off meetings, vendor calls, ).
- Intermediate knowledge of FDA and ICH regulatory requirements.
- May assist in preparing clinical study reports.
- May participate in project team meetings.
- Support the organization in maintaining a work environment that fosters learning, open communication, collaboration, integration, and teamwork.
- Other duties as assigned.
- BS, RN/PA, BSN degree or equivalent, and at least 3 years of industry clinical research experience. Half of this experience may be in-house and/or field experience gained through contract research organizations.
- Experience in one or more of the following therapeutic areas: inflammatory disease and/or infectious disease. Vaccine and/or NDA or BLA filing experience a plus.
- Good knowledge of GCPs, ICH, and FDA regulatory requirements governing human clinical trials.
- Demonstrated ability in critical thinking, problem-solving, and sound judgment.
- Excellent communication and interpersonal skills.
- Computer proficiency.
Personal attributes include:
- Integrity and flexibility
- Good organizational skills
- Excellent attention to detail
- Ability to prioritize and handle multiple tasks simultaneously
- A practical approach to clinical and regulatory processes
- Good judgment and decision-making experience
- Action and goal-oriented
- Collaborative and team-oriented