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Senior Clinical Research Coordinator

Sutter Health

This is a Full-time position in Berkeley, CA posted June 10, 2021.

Position Overview:

Under the supervision of the Clinical Research Services Supervisor, the Senior Clinical Research Coordinator (SCRC) participates in all areas of planning, coordinating, implementing and summarizing clinical studies, including study feasibility, regulatory and IRB follow-up.The SCRC also assists in the development of other specific research projects presented to, managed, or developed by the Research and Education Institute (REDI).This individual works with staff in the implementation of all research studies; gathers and transcribes data onto case report forms; maintains regulatory paperwork; preserves investigational product, laboratory supplies and other study related items; and maintains database records and reports as needed.

The SCRC 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 study start up logistics as well as tracks overall department enrollment; helps to ensure operations in accordance with policies and procedures.

The SCRC acts as an advisor for CRC(s) ensuring that proper training competencies have been accomplished and that overall workload can be managed safely and accurately.

The SCRC advises the Research Supervisor and 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 SCRC will also serve as the REDI Comprehensive Cancer Center (CCC) Research Program on-site leader to coordinate with other CCC departments and physician practices on a day-to-day basis, and as appropriate.

In addition and upon request, the SCRC will provide input into the performance and evaluations of other staff within the REDI CCC Research Program.

Qualifications:

Education: Bachelor’s degree or equivalent experience in a related field preferred.

Experience: 3 years Clinical Trials and/or other research experience required.Previous experience in patient care setting required

Certifications: Achievement of certification as CCRC
– clinical research coordinator certification required or obtained within 6 months of entering this position.SoCRA or ACRP Certification valid.

Skills & Knowledge:

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.

Basic understanding of safeguarding confidential information is required.Must be able to speak, read, write and understand the English language.

Ability to design and develop research protocols and provide basic statistical support and analysis as needed.

Strong organizational skills are needed to coordinate studies and manage study subjects.Ability to collect and interpret data, establish facts and draw valid conclusions.

Ability to write final research reports and submit results for conference presentations and/or publication, if desired by project team.

Oversee completion of lab and other test procedures; coordinate lab and specimen submission, packaging and shipping as needed

This position may regularly work, store, prepare, receive, unpack, transport, dispose of, or administer drug(s) identified as hazardous, or potentially hazardous, by the National Institute for Occupational Safety and Health (NIOSH) for purposes of USP 800.
Organization: Alta Bates Summit Medical Center
Employee Status: Regular
Benefits: Yes
Position Status: Non-Exempt
Union: No
Job Shift: Day/Evening
Shift Hours: 8 Hour Shift
Days of the Week Scheduled: Monday-Friday
Weekend Requirements: Other
Schedule: Full Time
Hrs Per 2wk Pay Period: 80
Applications Accepted: All Applications Accepted

Sutter Health Affiliates are equal opportunity employers EOE/M/F/Disability/Veterans
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