Assistant Director for Clinical Trials

Stony Brook University • Stony Brook, NY

9d • Onsite

About The Position

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 Director for Clinical Trials at Stony Brook School of Medicine.

Requirements

• Bachelor’s degree (foreign equivalent or higher)
• three (3) years of full-time experience in clinical research
• two (2) years of this working with sponsored clinical trials
• 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
• budget preparation and negotiation with the sponsor

Nice To Haves

• Master's degree (foreign equivalent or higher)
• Four (4) or more years of full-time experience in clinical research involving sponsored clinical trials
• Proficient in ONCOR Clinical Trials Management System
• Bilingual in Spanish

Responsibilities

• 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.
• Ensure 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.
• Budget development and negotiation for industry-funded clinical trials for SOM.
• Payment Terms negotiation with sponsors.
• Management of Clinical Conductor Clinical Trails Management System (CTMS). Creation of new studies and their negotiated budget
• Training of Study Coordinators on the use of the CTMS.
• Provide technical support to users of CTMS.
• Run monthly financial reports and queries for data entry.
• Study invoicing, payments, accounts reconciliation, and closeout.
• Oversees regulatory aspects of studies, such as IRB submission and ClinicalTrials.gov entries for research compliance.
• Day-to-Day study coordination, including patient recruitment and consent, study visits, collection, preparation, shipping of human samples, and data entry.
• Preparation of necessary documents, figures, and tables for research presentations, Data and Safety Monitoring Board meetings, and sponsor audits.
• Other Duties as assigned

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager