Clinical Research Associate
Required Qualifications (as evidenced by an attached resume): Bachelor's degree (foreign equivalent or higher). Two (2) years of full time progressively responsible experience working on clinical trials to include screening and consenting human subjects. Knowledge of regulatory requirements in human research.
Preferred Qualifications: Previous experience working on cardiology clinical trials. Experience completing web-based case report forms for industry sponsored research and completion of IRB documents. Proficiency in MS Office (Word, Excel, PowerPoint). CCRC – Certified Clinical Research Coordinator).
Brief Description of Duties: Working independently under general direction of the Principal Investigator the Clinical Research Associate performs tasks for complex studies. the incumbent ensures the smooth, accurate progress of the clinical trial from planning stage through trial completion and poststudy closure by working with the investigator, human subjects, Institutional Review Board, university and sponsor. The duties are as follows:
- Recruit, assess, enroll, screen, and schedule patients for eligibility in clinical cardiology research studies. Maintain database of participants. Review patient medical history using the EMR system to determine if patient is eligible for the study. Ensure all necessary testing and consents are completed prior to study according to protocol - ensure study compliance with institution and federal guidelines, as required.
- Ensure proper patient follow-up according to study protocol. Collect and compile clinical trial or study patient data. Maintain data for sponsor and investigator for research use as well as in presentations and publications. Assist in the preparation of presentation and publications. Develop and revise as necessary clinical research data forms.
- Maintain budgets, assist with grant preparation, submissions and renewals. Perform literature searches
- Liaison with sponsors, cooperative groups, regulating agencies, clinical departments and departmental staff. Monitor and maintain patient medical records during study. Prepare and distribute appropriate study information to patients.
- Ensure all technical, nursing and cardiology staff are educated on protocol of any given research study. Provide progress reports to investigator. Assist investigator with clinical trial related activities.
- May assist Principal Investigator with writing grants, grant submissions and renewals.
- Travel to investigator meetings and provide updates to sponsors, investigators and IRB.
- Other duties as assigned.
Stony Brook University has been tobacco free since 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 five Health Sciences schools — Dental Medicine, Health Technology and Management, Renaissance School of 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 180 pediatric specialists in 30 specialties, offers the most advanced pediatric specialty care in the region.
Stony Brook University/Research is an Equal Opportunity /Affirmative Action Employer. We encourage all to apply including individuals with disabilities and protected 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.
Visit our WHY WORK HERE page to learn about the total rewards we offer.
Job Field: Research Professional / Technical
Primary Location: US-NY-Stony Brook
Shift: Day Shift
Posting Start Date: Jul 9, 2019
Posting End Date: Jul 23, 2019, 10:59:00 PM