Clinical Research Associate II

Required Qualifications (as evidenced by an attached resume):
Bachelor's degree (foreign equivalent or higher). Three (3) years of full-time clinical research experience. Must have, keep, and maintain the appropriate valid NYS Driver’s License; have a motor vehicle record which is free from major violations or a pattern of repeat violations. (***Out-of-State Applicants, see "Special Notes”).
Preferred Qualifications:
Four (4) or more years of full-time clinical research experience. Prior Research Coordinator experience. Research with anesthesia, pain and/or clinical trials. Experience working with medical terminology. Experience with IRB preparation and submissions.
Brief Description of Duties:
The Department of Anesthesiology seeks a Research Study Coordinator to ensure smooth, accurate progress of clinical trials and studies from the planning stage through completion and post-study closure in accordance with federal, state, sponsor and university guidelines and policies. The incumbent will work with the investigator, human subjects, the Institutional Review Broad, university and sponsor. This position entails working some early morning or evening hours. The desired applicant must be detail oriented and have excellent interpersonal communication, organizational, and computer skills.
Duties:

• Coordinate various research trials and studies and ensure compliance with federal, state, university, and sponsor guidelines.
• Report adverse events and serious adverse events to proper regulatory agencies (i.e. IRB, study sponsor, FDA) and conduct appropriate follow-though to resolution.
• Perform sophisticated testing of study subjects un accordance with research protocols.
• Supervise the work of other staff involved in clinical trials and coordinate all clinical studies in the department.
• Enroll, register, and screen patients for clinical research trials and studies.
• Compile materials for submission to IRB, CORIHS, and University Hospital for initial study review, renewals, and study closeouts.
• Help to create source documents for studies.
• Interact and correspond with various internal and external constituents including sponsors, cooperative groups, Institutional Review Boards and various regulatory agencies.
• Compile case report forms and coordinate all monitoring activities with sponsor(s).
• Enroll, register, and screen patients for clinical research trials and studies.
• Collect and submit clinical trial and study patient data.
• Perform various administrative duties which may include proper collections and shipment of lab samples, billing, budgeting, and contract administration.
• Maintenance of clinical research study supplies and drug accountability.
• May coordinate and execute grant application submissions and renewals.
• Depending on the nature of the project, the incumbent may perform patient care responsibilities relate to the study or clinical trial protocol.
• Other duties as assigned.

Special Notes:
The Research Foundation of SUNY is a private educational corporation. Employment is subject to the Research Foundation policies and procedures, sponsor guidelines and the availability of funding. FLSA Exempt position, not eligible for the overtime provisions of the FLSA. Minimum salary threshold must be met to maintain FLSA exemption.
Evening and weekend work will be required at times.
May be required to work outside of regularly scheduled hours on nights and/or weekends.
This role will require travel between satellite locations, at times, multiple sites in a day.
***Out-of-State Applicants: Please note as a condition of employment and in order for this position to be tendered, the successful incumbent will be required to provide evidence of a valid license and driving abstract from the state issuing the license within five business days of a conditional offer and must obtain a NYS driver's license within 30 days of start date.
For this position, we are unable to sponsor candidates for work visas.
Resume/CV and cover letter should be included with the online application.
Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning, and working environment. All qualified applicants will receive consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, familial status, sexual orientation, gender identity or expression, age, disability, genetic information, veteran status and all other protected classes under federal or state laws.
If you need a disability-related accommodation, please call the university Office of Equity and Access (OEA) at (631) 632-6280 or visit OEA.
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The starting salary range (or hiring range) to be offered for this position is noted below, it represents SBU’s good faith and reasonable estimate of the range of possible compensation at the time of posting.