Clinical Trial Research Coordinator II- Vallejo

Job Summary:
The Clinical Trial Research Coordinator II (CTRC-II) is a position with demonstrated proficiency in coordinating clinical trial research tasks which, under the clinical direction of the Principal Investigator (PI), provides research, operational, and administrative support to the Kaiser Permanente Northern California (KPNC) PI and KPNC Clinical Trials Operations Director or designee, and other research staff conducting multiple FDA-regulated clinical trials. The CTRC-II is a hands-on position responsible for conducting the day-to-day activities of clinical trial project(s) under the supervision of the PI. The CTRC-II works more independently, assumes increased clinical trial responsibilities and requires periodic supervision.
This is a non-licensed position which works under the daily supervision of an experienced Clinical Trial Nurse, Clinical Trial Research Coordinator, and/or KFRI-designated, licensed clinical trial research staff member. This position must adhere to the positions scope of practice as outlined in the Major Responsibilities below. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants.
Essential Responsibilities:

- Compliance Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, 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 With supervision, prepare for inspections, audits and monitor visits.

- Study Implementation Maintain the security and confidentiality of participants paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol and/or IRB-approved telephone script, collect and document research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner. Coordinate and schedule participants for study assessments/visits, required tests, including visit specific lab kits and/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). With appropriate guidance, obtain and review medical records and test results of all project/study participants and abstract needed data per protocol requirements. With guidance from PI, complete case report forms (paper or electronic) and maintain a database program to track all study activity including study enrollment and consents. Respond to Sponsor to resolve data queries and delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions). Coordinate and prepare protocol specimens for shipping or storage in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Assist with participants long-term follow-up data collection. Assist PI and/or Clinical Trial Nurse, if applicable, with identifying, screening, and recruiting potential participants. Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage. With guidance, receive, disseminate and maintain study-related communications with internal and external parties involved with clinical trial protocols. Ensure that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. 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. With direction, maintain the site(s) study regulatory binder(s) and ensure that other study-specific documentation is maintained. Assist the Clinical Trial Nurse with quality assurance, training, abstracting and recording data. Coordinate space requirements for study-related equipment/supplies.

- Leadership and Communication With direction, communicate compliance and operational needs with internal and external parties, PI, Sponsor, Contract Research Organization (CRO), KPNC Clinical Trials Operations Director or designee, and KPNC Offices of Clinical Trial Compliance and Operations on an ongoing basis. If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with departmental and KP policies and procedures.

- Education and Training Work with an assigned mentor, as needed, for training and resource questions. With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested. Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested.

- Quality Improvement With direction, perform routine quality control activities with direction 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, and responsible use of operational research databases in compliance with KP policies. Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and procedures. Maintain systems and resources to effectively communicate with and obtain required IRB documentation.

- Staff Supervision No supervisory responsibilities.

- General Perform job functions according to the factors listed below under Job Criteria. Other duties as assigned by appropriate management.