Job Description
Supports and works closely with the Principal Investigator and Clinical Nurses to administratively coordinate protocol implementation for multiple research studies. CRC conducts day-to day activities of multiple studies with respect to compliance, regulatory, recruitment, study site initiation, monitoring and close out throughout the course of the research trials. The CRC follows protocol, institutional and regulatory requirements to assure accuracy of the study procedures being conducted.
Qualifications
Education & Training: Associate's degree in related field and Certified Clinical Research Professional (CCRP) or another research specific certification is strongly preferred.
Work Orientation & Experience: At least three (3) years' experience in clinical research with at least one (1) year of oncology research experience is strongly preferred. Knowledge of oncology clinical trials, pharmaceutical trials, federal regulations, IRB submissions and regulatory requirements. EPIC experience preferred.
Skills & Abilities:
Ability to:
(a) organize data management and regulatory aspects of clinical research activity,
(b) handle multiple priorities,
(c) work independently and take initiative in achieving expected results.
Demonstrate skills in:
(d) monitoring IRB and FDA clinical research policies and standards,
(e) making effective decisions,
(f) problem-solving,
(g) crisis management,
(h) verbal and written patient and staff educational presentations,
(i) organizing work, setting priorities, meeting deadlines,
(j) attention to detail and follow through,
(k) effective negotiation,
(l) working with physicians and multiple-specialty team members to obtain clinical data as required by the protocol,
(m) ability to work successfully with diverse types of individuals,
(n) is computer literate with proficiency in word processing, Excel, and data management software,
(o) ability to understand and use scientific/medical terminology and research theory in both oral and written communications.
(p) Skill in statistical interpretation and data analysis using statistical software as well as spreadsheet and database software applications.
