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.
Essential Functions:
- With supervision, assist with preparation for inspections, audits and monitoring visits.
- Maintain the security and confidentiality of participants' paper or electronic data.
- 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.
- With 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 resupplied 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.
- 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.
- Assume other duties as directed.
Secondary Functions:
Screen and recruit patients for clinical trials. Perform study-related procedures such as completing case report forms, answering and completing data queries, collect and process study specimens per protocol instructions, schedule study subjects clinic visits, administer and collect study questionnaires, track study subjects using institution's tracking systems, and other duties as assigned. Candidate will be required to travel to other KP sites, and be flexible with schedules to accommodate study and staffing needs. Must have minimum of one year experience coordinating clinical trials.
Qualifications:
Basic Qualifications:
- Clinical trials experience preferred.
- Minimum AA degree or two (2) years of work experience in an ambulatory and/or acute health care setting required. LVN may be substituted for an AA degree.
- Bachelor's degree may be substituted for one (1) year of work experience.
- Current BLS certification required.
- Willingness to obtain IATA/DOT certification.
- Demonstrate proficiency in medical terminology.
- Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program.
- Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.
- Must be proficient in electronic health systems and databases used in research environment and word-processing or willingness to learn within three (3) months of hire.
- Demonstrate organizational and communication skills.
- Demonstrate written, verbal, and interpersonal communication skills.
- 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.
- Ability to work in a Labor Partnership environment.
Preferred Qualifications:
- Bachelors or Masters degree, CCRC or CCRA, database management experience, project management experience a plus.
- Proficient in computer operations using Word and Excel.
- Valid driver's license.
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.