CT Reg Specialist II Job in Oakland, California Us
The Clinical Trial Regulatory Specialist II (CTRS-II) is a position w/ demonstrated proficiency which, under the direction of the KPNC clinical trials administrative mgmt or designee Principal Investigator (PI), provides regulatory document support to the KP Northern California (KPNC) PI research site(s) conducting multiple FDA-regulated or other clinical trials.
The CTRS-II has demonstrated proficiency in providing operational support for Sponsor and IRB regulatory compliance. The CTRS-II works independently and assumes increased responsibilities.
This position is also responsible for assisting in protecting the health, safety, and welfare of research participants. This is a non-licensed position which must adhere to the position's scope of practice as outlined in the Major Responsibilities below.
Essential Functions: W/ guidance from PI KPNC Clinical Trials Compliance Director, assist w/ ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP)
- Adhere to Guideline for Good Clinical Practice (GCP), federal, state, local regulations, KP policies procedures
- Assure all site documents including SOPs administrative files are maintained in audit condition
- Assist w/ internal external audits quality assurance activities including monitoring visits, audits inspections
- Support the cost effective aspects of the clinical trial
- Prepare IRB documents:
- Assist the PI other staff in the preparation, submission, maintenance of study-related regulatory documents
- W/ direction from PI prepare annual, interim final KPNC IRB reports
- Maintain licensure documentation including MD/RN licenses CVs
- Maintain training education documentation for research personnel
- Obtain regulatory certifications including KP laboratory state licenses, current laboratory certifications normal reference ranges
- W/ direction from PI, communicate w/ the Sponsor regarding study document regulatory file including scheduling conducting Sponsor-initiated monitor visits following-up on outstanding items
- Coordinate w/ the PI internal/external parties regarding the collection maintenance of regulatory IRB other documentation procedures
- Perform data entry into a database program to track pertinent study
- Maintain all study-related legal financial documents in separate confidential regulatory file
- Assist in study closure activities
- Act as liaison w/ internal/external parties regarding regulatory document activities.
- W/ direction, facilitate communication of regulatory documents requirements for multiple FDA-regulated or other clinical trials
- Participate as a member of the (CTOT) team attend meetings
- Assist w/ training of new hires
- Perform quality control activities assist w/ initiatives
- Adhere to departmental to ensure confidentiality, privacy security of clinical research interactions participant information, responsible use of operational research databases in compliance w/ KP policies
- Adhere to policies procedures to support high-quality implementation conduct of clinical trials, assure maintenance of research
- Maintain systems to effectively communicate w/ obtain required IRB documentation
- Participate w/ PI(s) clinical trials to identify prioritize the development of clinical trials' systems infrastructure to maintain research quality compliance of regulatory files at clinical trial sites
Qualifications:
Basic Qualifications: - 3 years effective project mgmt experience in clinical trials research or human subjects protections required.
- Bachelor's degree may be substituted for 1 year work experience.
- Minimum AA degree.
- RAC certification will be considered.
- CIP, CIM, ACRP or SOCRA certification required.
- Must be proficient in electronic health systems databases used in research environment, word-processing spreadsheets.
- Demonstrate proficiency in medical terminology.
- Demonstrate written, verbal, interpersonal communication skills.
- Attention to detail accuracy.
- Ability to effectively manage multiple tasks w/ strict timelines.
- Demonstrate prioritization organizational skills.
- Problem solving skills.
- Ability to be flexible dependable.
- Possess ability to work effectively on cross-functional teams.
- Present professional manner appearance.
- Comprehensive knowledge of the principles, methods procedures of basic medical /or clinical research processes.
- Comprehensive knowledge understanding of human research protection regulations, policies, procedures, standards as applied to IRB compliance operations.
- Comprehensive knowledge of GCP, federal, state, local regulations including HIPAA KP policies procedures.