Title: Clinical Trial Research Coordinator I
Location: Vallejo, CA
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 & administrative research support of the Kaiser Permanente Northern California (KPNC) PI & KPNC Clinical Trials Operations Director or designee, & 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, &/or KFRI-designated, licensed clinical trial research staff member. This position is also responsible for assisting in protecting the health, safety, & welfare of research participants.
Essential Functions:
- W/ guidance from PI, assists w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP) & document applications
- Adheres to Guideline for Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures
- Assists w/ preparation for inspections, audits, & monitoring visits
- Prepares packets for participants e.g., instructions, phone numbers, calendars, diaries, etc.
- Shipping of protocol specimens to the Sponsor lab in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines
- Directs issues requiring medical decision-making to the appropriate licensed staff member promptly
- Provides PI &/or Clinical Trial Nurse w/ the ongoing informed consent process by coordinating the current consent documents
- Documents research data & reports the information to the appropriate licensed staff member & PI for assessment
- Assists w/ data entry of study activity onto a case report form & maintains a database program to track all study activity
- Assists in ensuring that study-related, non-test article supplies are shipped & re-supplied according to protocol
- Assists in obtaining protocol specific regulatory documents including MDs/RNs licenses & CVs
- Supports the regulatory team in the maintenance of critical documents required to be maintained & provided to the Sponsor during the conduct of the trial
- Assists in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to long-term storage
- Communicates compliance & operational needs w/ internal & external parties, PI, KPNC Clinical Trials Operations Leader or designee, & KPNC Office(s) of Clinical Trial Compliance
- Participates in training & development activities to improve performance
- Works w/ an assigned mentor on a regular basis for training & resource questions
- Attends KP site-initiated meetings for protocol training including Sponsor-initiated meetings
- Participates as a member of the Clinical Trial Operations Team (CTOT) & attend meetings
- Adheres to departmental policies & procedures to ensure confidentiality, privacy, & security of clinical research interactions in compliance w/ KP policies
- Maintains systems & resources to effectively communicate w/ & obtain required IRB documentation
- No supervisory responsibilities
Secondary Functions:
-Responsible for assisting the Administrative Director for adult oncology clinical trials; monthly and quarterly meeting planning and set up, calendar maintenance, facilitate training for multiple sites/staff, supply ordering, assist with medical/nursing staff education; assist in ordering all protocol required items; preparation, collection, and shipment of all required protocol elements.
-Travel to other sites as needed for research activity/patient coverage.
-This job is in adult oncology. Home base will be Vallejo.
Qualifications:
Basic Qualifications:
- Minimum AA degree or 2 years of work experience in an ambulatory &/or acute health care setting required; LVN may be substituted for an AA degree
- Bachelor's degree or 1-year work experience
- Clinical trials experience preferred
- Willingness to obtain IATA/DOT certification
- Current BLS certification required
- Knowledge of GCP, federal, state, & local regulations including HIPAA & KP policies & procedures
- Must be proficient in electronic health systems & databases used in research environment & word-processing or willingness to learn within 3 months of hire
- Organizational & communication skills
- Written, verbal, & interpersonal communication skills
- Proficiency in medical terminology
- Attention to detail & accuracy
- Ability to manage multiple tasks
- Good prioritization & organizational skills
- Ability to be flexible & dependable
- Ability to work effectively on cross-functional teams
- Present professional manner & appearance
- Skill in administrative tasks i.e., filing, photocopying, faxing, etc
- Ability to work in a Labor Partnership environment
- Satisfies requirements for career advancement/maintenance as defined by the Clinical Trial Career Ladder Program
Preferred Qualifications:
- Minimum of 2-3 years experience as an administrative assistant.
- Medical background a plus.
- Ability to make and complete accurate and timely assessments.
- Demonstrated ability to work independently and cooperatively in multiple settings.
- Exhibited ability to set priorities and meet goals.
- Excellent verbal and written communication skills.
- Excellent documentation skills.
- Be flexible, organized, detail oriented and tenacious in follow-through.
- Possess the ability to work well under pressure.
- Computer skills in WORD, Excel and internet preferred.
- Willingand able to travel within the Northern California region with own dependable transportation.
- Willing to abide by Good Clinical Practice Guidelines and all FDA regulations.
++NOTE: This position iscontingent upon research funding. This job is in adult oncology. Home base will be Vallejo. Must be willing and able to travel within the Northern California region with own dependable transportation.++
