The Clinical Trial Research Coordinator II (CTRC-II) is a non-licensed position w/ demonstrated proficiency in coordinating clinical trial research tasks, which, under the clinical direction of the Principal Investigator (PI), provides research, operational, & administrative support to the Kaiser Permanente Northern California (KPNC) PI & KPNC Clinical Trials Operations Director or designee, & other research staff conducting multiple FDA-regulated clinical trials. The CTRC-II is a hands-on position responsible for conducting the day-to-day activities of clinical trial project(s) under the supervision of the PI. The CTRC-II works more independently, assumes increased clinical trial responsibilities & requires periodic supervision. This position is also responsible for assisting in protecting the health, safety, & welfare of research participants.
Essential Functions:
- With 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
- 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
- Performs job functions according to the factors listed below under Job Criteria
- Other duties as assigned by appropriate management
Secondary Functions:
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, report adverse events, perform quality monitoring activities, and other duties as assigned.
Qualifications:
Basic Qualifications:
- One (1) year in clinical trials research required
- 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 IATA/DOT certification required
- Current BLS certification required
- Current ACRP or SoCRA certification preferred
- Satisfies requirements for career advancement as defined by the Clinical Trial Career Ladder Program
- Must be proficient in electronic health systems and data bases used in research environment and word-processing and database software 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
- Attention to detail and accuracy
- Ability to manage multiple tasks
- Demonstrate prioritization skills
- Demonstrate problem-solving skills
- Demonstrate project management skills
- Ability to be flexible and dependable
- Possess ability to work effectively on cross-functional teams
- Present professional manner and appearance
- Possess ability to abstract pertinent protocol data from medical record
- Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.)
- Knowledge of the principles, methods and procedures of basic medical and/or clinical research processes
- Knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations
- Knowledge of clinical trials research and research regulations, as well as clinical trial experience in a specific therapeutic area
- Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures
- Ability to work in a Labor Partnership environment
Preferred Qualifications:
- Bachelors degree, LVN, CCRC, CCRP or CCRA certified, data and quality management experience, clincial research, Pediatrics or Pediatric-Oncology experience a plus.
- Proficient in computer operations using Word and Excel.
- Current CPR, DOT/IATA certifications.
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.