Clinical Trial Research Coordinator I
4 weeks ago
We are seeking a highly motivated Clinical Trial Research Coordinator I to join our team at Kaiser Permanente. As a novice level position, this role will assist in the operational and administrative research support of our clinical trials. Under the clinical direction of the Principal Investigator, you will work closely with our research staff to ensure the successful conduct of multiple FDA-regulated clinical trials.
Key Responsibilities:
- Compliance Ensure compliance with KPNC IRB Standard Operating Procedures (SOP) and document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures.
- Study Implementation Maintain the security and confidentiality of participants' data. Assist with scheduling participants for study assessments/visits, required tests, and paperwork preparation.
- Assist with obtaining medical records and test results for all projects/participants. Perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines.
- Provide ongoing informed consent process by coordinating current consent documents. Collect and document research data in a timely manner, and report the information to the appropriate licensed staff member and PI for assessment.
- Assist in maintaining research charts and site regulatory files. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol.
- Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial.
- Leadership and Communication Communicate compliance and operational needs with internal and external parties, PI, KPNC Clinical Trials Operations Leader or designee, and KPNC Office(s) of Clinical Trial Compliance on an ongoing basis.
- Education and Training Participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development.
- Quality Improvement Perform routine quality control activities and assist with quality improvement initiatives.
- Systems and Infrastructure Adhere to departmental policies and procedures to ensure confidentiality, privacy, and security of clinical research interactions and participant information.
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