Research Program Manager

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.

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.

Duties:

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
  
  
  
  

Other:

• 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

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 Non-Exempt position, eligible for the overtime provisions of the FLSA.

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.

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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.