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University of Rochester Sr Human Subject Res Coord - 219337 in Rochester, New York

Sr Human Subject Res Coord Job ID 219337

Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening

Full Time 40 hours Grade 055 Neurology Movement Disorders

Schedule

8 AM-4:30 PM; OCC WKENDS

Responsibilities

Position Summary:

Oversees the operations of assigned division(s) clinical research including supervision of clinical research staff as assigned. Provides support to the Principal Investigator, Research Administration, and research study staff working as an integral part of the study team. Responsible for the coordination and oversight of regulatory compliance for assigned division(s). Creates recruitment, retention and outreach planning for assigned division(s) to grow and enhance the clinical research operations.

Typical Duties:

Management Activities

  • Manages and mentors the Research Coordinators across the division or department as assigned.Responsible for the hiring, training and supervision of the division(s) research study staff.Leads regular team meetings for research study staff and is responsible for ongoing professional development including annual performance evaluations.Serves as a resource to coordinators and supports work needs as necessary.

  • Evaluates manpower as it relates to the division(s) portfolio of clinical research studies. Determines appropriate personnel needs to support the various studies in the division(s). Manages time and effort of the coordinators on clinical research studies and monitors the studies’ financial data to reassign the staff accordingly.

  • Tracks and monitors metrics associated with study start up, recruitment, enrollment, protocol violations, adverse events, amendments, regulatory filings etc. for the division(s).Monitors the progression of all studies and initiates improvement action when needed.Prepares and presents routine reporting to division and departmental leadership.

  • Develops clinical research budgets in coordination with the Research Administration team.Provides data driven estimates related to time and effort, enrollment figures and rates, etc. to assist in appropriate budgeting for trials. Meets regularly and communicates with Administrators on research project operations and budgetary updates.

    Regulatory Compliance Activities

  • Oversees compliance with regulatory and institutional requirements and designs systems and processes to monitor and document routine audits for all divisional studies.Creates, implements and manages SOPs for regulatory documentation management and study files across the division. Ensures a high level of quality and compliance by identifying trends and issues and initiating corrective actions.

  • Monitors and reviews all study data through routine monitoring and establishment of controls and ongoing quality assurance.Collaborates with study coordinators, sponsors, and investigators to collect data and establish expectations of timely and accurate completion of case report forms.

  • Trains divisional coordinators on protocol procedures, new test/surveys, and other human subject research and sponsor requirements. Evaluates and monitors effectiveness of training and develops new training methods.Directs preparation of IRB submissions.

  • Keeps current with all federal, state, sponsor, and institutional policies, laws, SOP’s and guidelines.Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines.Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies for the purpose of implementing, managing and evaluating resulting study changes.

    Recruitment, Retention, & Outreach

  • Reviews all divisional protocols and inclusion/exclusion criteria along with Principal Investigator for feasibility analysis prior to clinical trial agreement execution.

  • Designs strategy for recruitment and retention of study participants for all studies across the division. Trains and educates divisional coordinators on the recruitment and retention plan and assists with executing plan.

  • Builds relationships with sponsors, advocacy groups, community and the institution to assist with strategic growth of the division’s research. Creates communications and materials to keep key stakeholders informed of divisional research activities. Develops educational materials for patients regarding ongoing studies and opportunities to participate.

  • Responsible for outreach and education including updates to various websites regarding active research, results, presentations, organization patient day events etc. across the division. Assists with data analysis and preparation of materials for publications.

    Qualifications:

    Bachelor’s degree and five years of experience in human subject research coordination; or an equivalent combination of education and experience. Previous supervisory experience preferred. Professional Research Coordinator Certification (SoCRA) Preferred. Knowledge of work processing and data analysis software preferred.

    How To Apply

All applicants must apply online.

EOE Minorities/Females/Protected Veterans/Disabled

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