CenterWatch

Keep the discussion going--join our JobWatch Group on LinkedIn!

Sign In
 [New User? Sign Up]
Mobile Version

RN Clinical Research Coordinator

Sutter Health


Location:
San Mateo, California
Date:
04/10/2018
2018-04-102018-05-10
Categories:
  • Clinical Operations
Sutter Health
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Description
The Clinical Research Coordinator (CRC) participates in all areas of planning, coordinating, implementing and summarizing clinical studies, including study feasibility, regulatory and IRB follow-up. The CRC also assists in the development of other specific research projects presented to, managed, or developed by Mill Peninsula Health Services (MPHS). This individual works with staff in the implementation of all research studies; provide training; project leadership; quality control oversight gathers and transcribes data onto case report forms; maintains regulatory paperwork; preserves the investigational product, laboratory supplies, and other study related items; and maintains database records and reports as needed. The CRC may initiate protocol design and development as well as statistical analysis for investigator-initiated research protocols and will also make suggestions for workload assignments for the Clinical Research Coordinators (CRC) and coordinates pre-qualification, site initiation visits and performs other studies start-up logistics as well as tracks overall department enrollment; helps to ensure operations in accordance with policies and procedures. The CRC acts as an advisor for ensuring that proper training competencies have been accomplished and that overall workload can be managed safely and accurately. The CRC advises the leadership of all resource allocation, data management issues, and new study opportunities by facilitating effective, timely reporting, either at scheduled protocol review meetings or via one-on-one meetings and performs other duties as assigned. The CRC will also serve on-site leader to coordinate with other MPHS departments and physician practices on a day-to-day basis, and as appropriate. In addition and upon request, the CRC will provide input into the performance and evaluations of other staff within MPHS.This is an exempt position that may require overnight travel and weekend assignments.

Critical and Analytical Thinking
  • Manages and oversees individual study protocol procedures and requirements as defined in the research study protocol.
  • Collaborates in protocol review in analyzing study feasibility.
Communication
  • Functions as a leader of the research team, communicating with other team members for the efficient management of studies.
  • Prepares and maintains clinical trial regulatory documents.
  • Submits SAEs, IND safety reports and progress reports on time to assure continuing human subject protection and project approval as required by the IRB guidelines and applicable regulatory agencies.
Technical Skills
  • Completes case report forms as required by individual sponsor protocols and coordinates sponsor monitoring visits with timely resolution of sponsor queries.
  • Provides source documentation and patient records as required.

Qualifications
 
CA RN Lic
CRC (Or obtainable within 6 months of employment)
3 years Clinical Trials and/or other research experience required.
Previous experience in patient care setting.
Knowledge of research process and specialty required.
Demonstrated knowledge of participation in a multi-disciplinary team is required
Extensive medical terminology and knowledge required; computer and clerical skills required; Extensive and excellent organizational skills, as well as the ability to communicate effectively, are required.
Thorough knowledge and understanding of FDA and HHS regulations protecting human subjects in research, including GCP/ ICH guidelines, is required.

Primary Location: California, Peninsula/South Bay and Santa Cruz, San Mateo
Organization: Mills-Peninsula Health Services
Employee Status: Regular
Benefits: Yes
Position Status: Exempt
Union: No
Job Shift: Day
Shift Hours: 8 Hour Shift
Days of the Week Scheduled: Monday-Friday
Weekend Requirements: None
Schedule: Full Time
Hrs Per 2wk Pay Period: 80
Powered ByLogo