Assistant Director for Clinical Trials Job Stony Brook area,New York USA,Research/Development

Job Description – Assistant Director for Clinical Trials (2602399)

Assistant Director for Clinical Trials

Required Qualifications (as evidenced by an attached resume):

Bachelor’s degree (foreign equivalent or higher) plus three (3) years of full-time experience in clinical research with 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 and budget preparation and negotiation with the sponsor.

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.
Proficient in ONCOR Clinical Trials Management System.
Bilingual in Spanish.

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 Director for Clinical Trials at Stony Brook School of Medicine.

Duties:

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.

Other:

Oversees regulatory aspects of studies, such as IRB submission and Clinical Trials.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

(No details provided)

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.

Essential Position:

Essential Position: This has been designated as an essential position based on the duties of the job and the functions performed. Positions that are designated as such may be required to report to work/remain at work even if classes are canceled, and the campus is working on limited operations in an emergency.

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

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…