Job Summary:
The Clinical Trial Research Coordinator I (CTRC-I) is a novice level position which, under the clinical direction of the Principal Investigator (PI), assists in the operational and administrative research support of 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. 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, assist with ensuring 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, assist with preparation for inspections, audits and monitoring 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). Assist with scheduling participants for study assessments/visits, required tests including visit-specific laboratory kits and/or paperwork preparation. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.).

Assist with obtaining medical records and test results for all projects/participants. ith supervision and certification, perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.

Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, 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 the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).

Under specific direction, assist with data entry of study activity onto a case report form (paper or electronic), and maintain a database program to track all study activity (i.e., study enrollment and consents). Assist in maintaining research charts and site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses and CVs.

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. With supervision, assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.

Leadership and Communication With direction, 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. 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 With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Work with an assigned mentor on a regular basis for training and resource questions. 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 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.

Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees.

Basic Qualifications: Experience

Education

Associates degree or higher OR 2 years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted for an Associates degree)
High School Diploma or General Education Development (GED) required.

License, Certification, Registration

Additional Requirements:

Willingness to obtain IATA/DOT certification prior to start date.
Current BLS certification required prior to start date.
Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.
Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within 3 months of hire.
Demonstrate organizational and communication skills.
Demonstrate written, verbal, and interpersonal communication skills.
Demonstrate proficiency in medical terminology.
Demonstrate attention to detail and accuracy.
Ability to manage multiple tasks.
Demonstrate good prioritization and organizational skills.
Ability to be flexible and dependable.
Ability to work effectively on cross-functional teams.
Present professional manner and appearance.
Demonstrated skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).
Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
Must be able to work in a Labor Partnership environment.

Preferred Qualifications:

Clinical trials experience preferred.