Research Program Coordinator II-Addiction Institute Mount Sinai

 

Strength Through Diversity

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Roles & Responsibilities: 

Requirements: 

The Research Program Coordinator II supports program leadership and helps manage the activities and functions of the Clinical Trials Division of the Addiction Institute of Mount Sinai (AIMS) to ensure that goals and objectives specified for the program are accomplished in accordance with established priorities, time limitations, funding limitations or other specifications.    The Research Program Coordinator will provide a broad range of program management services for new and ongoing projects including:

Operational management of clinical trials:

• Maintain operational management of clinical research protocols.

• Oversees and manages the activities of clinical research coordinators, research assistants, and lab technicians, and provides leadership and direction for staff, setting an effective agenda to ensure that performance goals for clinical trials are met.

• Oversees daily operations and coordinates program activities through assigned staff; prioritizes and delegates work activities.

• Develops and independently implements new or revised program goals, strategies and objectives to sustain and grow programs and services for the Clinical Trials Division.

• Develops and schedules a program work plan and schedules in accordance with specifications, objectives, and funding limitations; 

• Assist in training staff and conduct of activities related to clinical research studies including tasks such as obtaining screening participants, informed consent, educating participants regarding study requirements, administering research tasks.

• Confers with and advises staff and others to provide technical advice, problem solving assistance, answers to questions and program goals and policy interpretations; refers to appropriate supervisor when unable to respond.

• Prepares periodic reports and records on program activities, progress, status or other special reports for management or outside agencies/funders.

• Reviews applications or other program documents to determine acceptance or make decisions pertaining to program.

• Interacts and maintains liaison with students, volunteers, faculty, staff and outside/community agencies or committees in facilitating program objectives. 

• Performs other related duties. 

• Supervise Research Coordinators, Lab Techs, and other new staff.

• Provide training on research processes and procedures.

• Develop SOPs for study start-up, procedures, close-out, and other policies (e.g., create instruction manuals for staff to follow, escalating issues if/when they are not resolved).

• Assist with oversight on budgets/funds and spending, including recommending sources/distribution.

• Assist with hiring and onboarding new personnel, including recruitment, outreach, and plenty of liaising with HR.

• Lead operational team meetings and be in-the-know about operational/administrative policy/procedural changes throughout Sinai.

• Attend some project meetings, mostly in the early stages, to help map out what regulatory forms need to be completed and when, as well as at what points new staff need training.

• Assist the Directors and Program Manager in other areas as needed.

Duties and Responsibilities         

• Operational Management of Clinical Trials: Manages the implementation of clinical research projects. Delivers broad oversight and direction to research coordinators and other study personnel during initial project set up and ensures study implementation plan follows the approved protocol. Coordinates technical trainings relative to program (e.g., data collection software). Reviews progress of projects regularly and guides research staff to proactively initiate appropriate actions to achieve studies target objectives. Acts as a resource to address issues related to participant accruals and advises research staff to ensure milestones adhere to project timeline. Organizes and leads regular project meetings to ensure completion of project activities within projected timelines and as outlined in study protocols. Communicates project status to Principal Investigators and other concerned parties.

• Regulatory: Assists with the development of new IRB submissions with research staff and oversees IRB amendments and renewals. Helps to maintain regulatory documentation and compliances with polices of NIH, DEA, FDA regulations. Prepares and responds to monitoring visits by internal and external monitors. Works with research associates in the resolution of all issues and assists in resolving complex processing problems. Maintains awareness of study regulatory status and works with research staff to ensure regu