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 position's 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.
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.
Secondary Functions: Primary responsibilities are to provide data management in a timely manner for patients on cancer trials including facilitating patient entry into programs and managing and collecting data for submission to research centers. Will manage all screening, active treatment and follow up data form submissions, x-rays, and pathology specimens for all protocols patients. Will assist in the oncologists- in ordering/scheduling specific protocol tests/appointments as directed by physician or research nurse. Will require travel by own reliable transportation to different centers and interactions with pharmacists, oncologists- surgeons, oncology nurses and patients to assist in patient enrollment and adherence to all research requirements. Maintain IRB regulatory material at the local site level. Coordinate adverse event/serious adverse event submissions to the IRB and sponsors. Prepare and assist in any required audits.
Basic Qualifications: Experience
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
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.