Clinical Research Associate
2 weeks ago
Immediate need for a Clinical Research Associate in Carpinteria, CA with a biotech company. Must have strong TMF and/or Veeva TMF. Must also be willing to work on site 2-3 days per week.
Summary:
The Clinical Research Associate (CRA) will support successful and timely start-up and completion of clinical trials and be a key member of the Organization of Chief Medical Officer (OCMO) Global Clinical Affairs team. This will include oversight and management of assigned study(ies) associated investigator sites and monitoring activities. The CRA will monitor clinical trials in accordance with Good Clinical Practice (GCP), Agilent procedures, and all applicable regulations. The CRA works closely with the Clinical Trial Manager (CTM) and/or lead CRA to ensure all monitoring activities are conducted according to study requirements and Monitoring Plan. The CRA reports to a manager of clinical operations and has no direct reports.
Primary Responsibilities (all levels):
- Performs all study monitoring visits and completes supporting visit reports, including applicable visits such as site/investigator qualification, site initiation, interim monitoring, remote monitoring, and close-out visits
- Trains investigator(s) and site staff on study protocol and all relevant study procedures
- Support study start-up, conduct, and closeout activities. May assist in developing study-related plans and documents including clinical protocol, clinical brochures/IFUs, development of CRFs, reviewing informed consent forms, monitoring plan, etc. May coordinate IRB/EC approvals
- Functions independently in the field and interacts professionally with all levels of medical and scientific professionals
- Identify early on any unsatisfactory results, operations or specific problems and take immediate action to appropriate groups including escalating and assisting in resolving any study related issues that arise during study conduct
- Assures adherence to GCP, study protocol, procedures, all applicable requirements, and regulations throughout the study monitoring visits. Responsible for implementing and maintaining the effectiveness of the quality system
- Collect and review site regulatory and essential documents for accuracy and completion. Maintain the study Trial Master File (TMF)/or eTMF and ensure the Investigator Site Files (ISFs) are current and maintained
- Perform Source Data Verification (SDV) and data cleaning in accordance with study monitoring plan. Reviewing all study logs and documentation ensuring audit trail and chain of custody is maintained
- Performs Investigation Use Only (IUO) or Research Use Only (RUO) inventory and accountability, in accordance with study monitoring plan. Facilitates return or destruction of any unused IUO/RUO material as required
- Serve as the primary point of contact for assigned sites and works with sites to resolve data queries and monitoring findings. Maintains accurate and timely communications with sites and ensures records are filed in TMF/ISF
- Ensures TMF/ISF is audit ready. Assists with site audit(s) and site quality management activities, as needed. Tracks site progress against contractual agreements
- Contribute to organizational and departmental process development, improvement, and implementation
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