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Clinical Research Associate II

Stony Brook University


Location:
Stony Brook, New York
Date:
11/30/2017
2017-11-302017-12-30
Job Status:
Full Time
Categories:
  • Clinical Operations
Stony Brook University
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  • Research Salary

Job Details

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. 

 

Preferred Qualifications:

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

Stony Brook University is 100% tobacco-free starting January 1, 2016. See our policy and learn more at stonybrook.edu/tobaccofree.

About Stony Brook: 
Long Island’s premier academic medical center, Stony Brook Medicine represents Stony Brook University’s entire medical enterprise and integrates all of Stony Brook’s health-related initiatives: education, research and patient care. It encompasses Stony Brook University Hospital, Stony Brook Children’s Hospital, the six Health Sciences schools — Dental Medicine, Health Technology and Management, Pharmaceutical Sciences, Medicine, Nursing and Social Welfare — as well as the major centers and institutes, programs and more than 50 community-based healthcare settings throughout Suffolk County. With 603 beds, Stony Brook University Hospital serves as Suffolk County’s only tertiary care center and Regional Trauma Center. Stony Brook Children’s, with more than 160 pediatric specialists, offers the most advanced pediatric specialty care in the region.

Equal Opportunity Employer, females, minorities, disabled, veterans

If you need a disability related accommodation, please call the University Human Resource Services Department at (631) 632- 6161 or the University Hospital Human Resources Department at (631) 444-4700. In accordance with the Title II Crime Awareness and Security Act, a copy of our crime statistics is available upon request by calling (631) 632- 6350. It can also be viewed on line at the University Police website at http://www.stonybrook.edu/police

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