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The Clinical Research Coordinator is responsible for management of Research Studies and Clinical Research Data management.
Research: Under the supervision of the Clinical Research Manager and/or Physician, the Clinical Research Coordinator (CRC) participates in all areas of planning, coordinating and implementing clinical research studies, including regulatory, data collection and entry, and IRB follow-up. The CRC also assists in the development of other specific research projects presented to, managed, or developed by the SVMHS Clinical Research Department. Specific responsibilities include: gathering and transcribing data into Case Report Forms, maintaining regulatory paperwork, preservation of investigational product, laboratory supplies and other study-related items; and maintaining database records and reports as needed. The CRC may provide training, project leadership, and quality control oversight of entry level research coordinators. The CRC will be capable of coordinating clinical trials in any target therapeutic area, with a particular focus on cardiovascular and oncology clinical trials.
Data Management: This individual will be responsible for assisting in the management of studies such as cancer studies sponsored by the NCI, e.g. Eastern Cooperative Oncology Group and others. The CRC assures effective data screening and management necessary to support external data registry submission, monitoring and evaluation functions, physician data, and review functions for the hospital. Disseminates information as needed in accordance with established HIPAA guidelines.
This position requires a thorough understanding of management of information, and the ability to interact with a wide variety of ethnically diverse people, including patients, their families, physicians, financial staff, clinical staff and information systems. Utilizes clinical knowledge and assessment skills to identify and screen potential research patients using established criteria. Enrolls and maintains records of all clinical research patients.
Education: A minimum of a bachelor's degree required.
Licensure: Certified Clinical Research Coordinator (CCRC) by the Association of Clinical Research Professionals (ACRP) or by the Society for Clinical Research Associates (SoCRA) required. New hires/transfers have four (4) years from date of hire/transfer to obtain CCRC certification. Current BLS/Healthcare Provider status as per American Heart Association standards required. New Hires/Transfers have a 6-month grace period to obtain BLS certification and must continually remain current. Current CITI Training certificate of completion required. Current IATA approved course on Shipping & Handling of Dangerous Goods required. New hires/transfers have a 3-month grace period from date of hire/transfer to obtain CITI and Shipping & Handling of Dangerous Goods certifications and must continually remain current.
Experience: Minimum 3-5 years of clinical trial experience, preferably working with patients on the site side of clinical trials (as opposed to industry). One year of experience managing research and/or data projects preferred. Experience in data entry and ability to work in multiple proprietary programs preferred.
The hourly rate for this position is $30.17 - $36.20. The range displayed on this job posting reflects the target for new hire salaries for this position.
Job Specifications: Union: Non-Affiliated Work Shift: Day Shift FTE: 1.0 Scheduled Hours: 40
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