Assistant Director for Clinical Trials

Stony Brook University is committed to excellence in diversity and the creation of an inclusive learning and working environment.

About the Role

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. Reports directly to the Associate Director for Clinical Trials at Stony Brook School of Medicine.

Responsibilities

• Develops, manages, and evaluates administrative and financial policies and procedures for the Clinical Research Core.
• Develops position descriptions, hires, trains, supervises, and performs yearly reviews for staff.
• Provides expertise, training, and mentoring to research staff, including Investigators and Study Coordinators.
• Facilitates study start-up, including budget development, contract negotiation, and administrative approvals.
• Manages financial aspects of industry-funded clinical trials for multiple departments within the School of Medicine (SOM).
• Establishes collaborative processes and shared resources among other SUNY campuses to identify common needs.

Staff/Personnel Responsibilities

• Supervises Clinical Research Coordinator (CRC) staff, assigns work, performs quality assurance, and manages performance reviews and evaluations.
• Ensures adherence to policies and procedures.
• Trains and mentors staff, including Principal Investigators (PIs), department administrators, and Study Coordinators, on research-related practices.
• Facilitates educational research training for study coordinators throughout the year.

Financial Responsibilities

• Develops and negotiates budgets for industry-funded clinical trials.
• Negotiates payment terms with sponsors.
• Manages the Clinical Conductor Clinical Trials Management System (CTMS), including creation of new studies and their budgets.
• Trains Study Coordinators on the use of CTMS and provides technical support to users.
• Runs monthly financial reports, handles study invoicing, payments, accounts reconciliation, and closeout.

Study Coordination and Compliance

• Oversees regulatory aspects of studies, including IRB submission and ClinicalTrials.gov entries for research compliance.
• Coordinates day-to-day study activities, including patient recruitment and consent, study visits, collection, preparation, and shipping of human samples, and data entry.
• Prepares documents, figures, and tables for research presentations, Data and Safety Monitoring Board meetings, and sponsor audits.

Requirements

• Bachelor’s degree (foreign equivalent or higher) plus three (3) years of full-time experience in clinical research, with two (2) years working with sponsored clinical trials.
• Administrative and managerial experience with research projects and clinical trials involving an external sponsor.
• Supervisory experience, including supervising research coordinators.
• Experience working with research protocols and budget preparation and negotiation with sponsors.

Preferred Qualifications

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

Benefits

Visit the WHY WORK HERE page to learn about the total rewards offered.

Pay

Starting salary range: $85,000–$100,000.

Schedule

Full-time. FLSA exempt position, not eligible for overtime provisions. This is an essential position and may require reporting to work or remaining at work during emergencies, even if classes are canceled or the campus operates on limited operations.

For this position, we are unable to sponsor candidates for work visas.