REQUIRED QUALIFICATIONS (AS EVIDENCED BY AN ATTACHED RESUME):

Master’s degree (foreign equivalent or higher) and three (3) years of full-time experience in clinical research with two (2) years of this working with sponsored clinical trials. In lieu of a Master’s degree, a Bachelor’s degree (foreign equivalent or higher) plus five (5) years of full-time experience in clinical research with two (2) years of this working with sponsored clinical trials may be considered. Administrative and managerial experience working with research projects and clinical trials involving an external sponsor. Supervisory experience to include supervising research coordinators. Experience working with research protocols and budget preparation and negotiation with the sponsor.

PREFERRED QUALIFICATIONS:

Four (4) or more years of full-time experience in clinical research involving sponsored clinical trials.

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BRIEF DESCRIPTION OF DUTIES:

The incumbent directs the day-to-day operations of the Clinical Research Core, developing, managing, and evaluating all administrative and financial policies and procedures of the office. Responsible for developing position descriptions, hiring, training, supervising, performing yearly reviews, etc. Provides expertise, training, and mentoring to research staff, not limited to Investigators and Study Coordinators. Facilitates study start up (budget development, contract negotiation, administrative approvals, etc.), as well as manages financial aspects of industry-funded clinical trials for a number of departments within the SOM. Establishes collaborative processes and shared resources among other SUNY campuses with the goal of identifying common needs. Reports directly to the Associate Vice Dean for Research Operations at Stony Brook School of Medicine.

STAFF/PERSONNEL RESPONSIBILITIES:

• Sets strategic goals for the Clinical Research Core (CRC) for review by Vice Dean for Research
• Supervises day to day operations of the Clinical Research Core (CRC)
• Supervises CRC staff, providing specific work assignments to staff in order to facilitate research at SBU, performing QA on assigned work, carrying out performance programs reviews and evaluations, managing time off requests, etc.
• Ensures that policies and procedures are adhered to.
• Trains and mentors staff (PI’s, department Administrators, Study Coordinators, etc.) on research related practices.
• Facilitates educational research training to study coordinators throughout the year (The Coordinator Training and Mentorship Group-CTMS

FINANCIAL RESPONSIBILITIES:

• Sets fiscal goals annually for CRC and is responsible for all financial aspects of the CRC, monitoring cost center, billing, recharges, purchasing, and expenditures.
• Budget development and negotiation for industry-funded clinical trials for SOM.
• Payment Terms negotiation with sponsors.
• Management of Clinical Conductor Clinical Trials Management System (CTMS). Creation of new studies and their negotiated budgets.
• Training of Study Coordinators on the use of the CTMS
• Provide technical support to users of the CTMS
• Run monthly financial reports and queries for data entry
• Study invoicing, payments, accounts reconciliation, and closeout