Clinical Research Associate II
Clinical Research Associate II-1702772
Required Qualifications: (As Evidenced by an Attached Resume)
Bachelors degree in Nursing. Licensed to practice as a RN in NYS. Five years of full time progressively responsible management experience with a demonstrated ability in budget planning and HR management.
Previous work experience in an academic health care setting, experience with NIH grants, clinical trials and industry sponsored research. Knowledge of the IRB and regulatory processes. Additional years of related research experience in Cardio-Metabolic health. Proficiency with MS Office. Certified Clinical Research Coordinator (CCRC).
Brief Description of Duties:
The Clinical Research Associate II will ensure that the Heart Institute is maximizing its ability to enroll patients, review applications submitted to the IRB and develop recruitment and retention plans to keep participants. The incumbent will possess excellent interpersonal skills and team building skills with a solid understanding of the organizational dynamic.
- Review study protocols for feasibility and work with associated clinical departments/units (Investigational Drug Service, Laboratory Services, scheduling and registration as well as different multi-departmental disease health care teams) to ensure the Heart Institute is maximizing its ability to enroll patients into trials.
- Responsible for new, continuing review, and all amendments to IRB applications submitted to the Office of Research Compliance, regulatory agencies and sponsors.
- Develop and initiate clinical policies and procedures to ensure high quality compliance for protocols. Development of recruitment and retention plans for individual clinical trials. Screen, recruit subjects and complete case report forms.
- Ensure all necessary testing and consents are completed prior to study according to protocol, ensure study compliance with institution and federal guidelines as required.
- Work directly with the office of Clinical Trials with budget development for all clinical trials. Assist in the preparation of presentations and publications.
- Act as a liaison with sponsors, cooperative groups, regulatory agencies, clinical departments and departmental staff. Internally audit, monitor and maintain patient medical records during the study.
- Travel to investigator meetings and provide updates to sponsors, investigators and the IRB
- Other duties as assigned.
Special Notes: FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption
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Official Job Title: Clinical Research Associate II
Job Field: Research Professional / Technical
Primary Location: US-NY-Stony Brook
Department/Hiring Area: Medicine - Cardiology-The Research Foundation for The State University of New York at Stony Brook
Schedule: Full-time Day Shift 8:30am - 5:00pmMedicine - Cardiology-The Research Foundation for The State University of New York at Stony Brook
Posting Start Date: Oct 3, 2017
Posting End Date: Oct 17, 2017, 11:59:00 PM
Salary: $70,000-$80,000 / Annual @ 1.0 FTE. CWE
Salary Grade: E99