Remote Regulatory Coordinator

2 weeks ago

Tigard OR, United States Kaiser Permanente Full time

This position is based in Portland, OR, and will by hybrid (onsite/remote).

The Clinical Trial Research Coordinator II (CTRC-II) is a position with demonstrated proficiency in coordinating clinical trial research 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 and supervisor. The CTRC-II works more independently, assumes increased clinical trial responsibilities, and requires periodic supervision. This is a non-licensed position which works in partnership with the Clinical Trial Nurse, Project Managers, and Investigators. This position is also responsible for assisting in protecting the health, safety, and welfare of research participants.

With guidance from PI, ensure compliance with KPNW 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.
- Maintain the security and confidentiality of participants paper or electronic data (e.g., Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.
- According to protocol and/or IRB-approved materials, collect and document research data and report the information to the appropriate licensed staff member and PI for assessment in a timely manner.
- 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.
- 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 consenting potential participants.
- 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.
- With direction, communicate compliance and operational needs with internal and external parties, Project Manager, PI, other research staff, Sponsor, Contract Research Organization (CRO), etc. 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.
- 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.
- With direction, perform routine quality control activities with direction and assist with quality improvement initiatives.
- 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. Minimum one (1) year of experience in clinical trials research OR a bachelors degree.

Associates degree or higher OR two (2) years of experience in a directly related field.
- License, Certification, Registration

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