What are the responsibilities and job description for the Clinical Trial Research Coordinator I position at Kaiser Permanente?
- ComplianceSupport & comply w/ the Principles of Responsibility (Kaiser Permanente Code of Conduct). W/ guidance from PI, assist w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures. W/ supervision, assist w/ preparation for inspections, audits & monitoring visits.
- Study Implementation: Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist w/ 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 w/ obtaining medical records & test results for all projects/participants. w/ supervision & certification, perform packaging & shipping of protocol specimens to the Sponsor lab in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.
- Provide PI and/or Clinical Trial Nurse w/ the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, collect & document research data in a timely manner, & report the information to the appropriate licensed staff member & PI for assessment. Assist in the collection of protocol-required data w/ timely & accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).
- Under specific direction, assist w/ data entry of study activity onto a case report form (paper or electronic), & maintain a database program to track all study activity (i.e., study enrollment & consents). Assist in maintaining research charts & site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped & re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses & CVs.
- Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance & storage of critical documents required to be maintained & provided to the Sponsor during the conduct of the trial. W/ supervision, assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage.
- This job description is not all encompassing.
Qualifications:
Basic Qualifications:
Experience
- N/A.
Education
- Associate's degree or higher OR two (2) years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted for an Associate's degree)
- High School Diploma or General Education Development (GED) required.
License, Certification, Registration
- N/A.
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.
