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Site Operations Manager

Full Time
Michigan
Posted 4 weeks ago

Responsible for management and organization and conduct of all research sites.

Clinical Site Operations Manager role and responsibilities:

  • Accountable for meeting accrual metrics (actual vs. targeted enrollment) and leads to ensure timely, and efficient initiation and completion of all clinical trials.
  • For recruitment, provide leadership of EMR-review teams and functions to ensure optimal research participant recruitment for all research teams.
  • Obtain site EMR access for all necessary research staff.
  • Coordinate with the CRCs on the recruitment efforts.
  • Manages all duties necessary for effective and compliant clinical research study coordination for multiple therapeutic areas, including planning, organizing, and managing all activities related to clinical research operations and execution of timelines.
  • Maintains awareness of overall development in the field of clinical research and ensures that staff remains current on clinical monitoring developments.
  • Maintains an awareness of company policies to effectively represent the company perspective to clinical staff.
  • Collaborates with other department and/or functional groups to ensure consistency of processes.
  • Supports management in assuring professionalism and adherence to company principles of Customer Service and Company Culture.
  • Supports implementation of new company initiatives in terms of process improvement or new technology related to clinical research.
  • Directly or indirectly supervise study staff by ensuring compliance and address any employee compliance issue or concerns as needed.
  • Demonstrate ability to lead by example and to encourage team members to seek solutions.
  • Review and revision of departmental SOPs, working practices, and policies.
  • Development of strategic departmental goals which correlate with corporate goals and formalize departmental action plans to meet those goals.
  • Process Improvement Plans and other special projects as required by the department.
  • Develops strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
  • Assist with required study startup training, documentation, start-up tasks and timelines on assigned study protocols.
  • Conducts field evaluation visits with staff at sites to check compliance.
  • Collaborate with corporate teams to ensure staffing, start-up, and trial goals are met.
  • Maintain effective, courteous and ongoing communication with staff, sponsor, research participants, and PI during the course of trials.
  • Assists with organizing and conducting Staff Meetings at regular intervals and addresses issues discovered at meetings.
  • Coach, train, and support research staff.
  • Ensure staffing and resource needs are met on both day-to-day and strategic basis.
  • Assesses and organizes appropriate training requirements for research staff
  • Communicates staff training needs to Director.
  • Assists Director to create and deliver new department initiatives, improvement plans or training.
  • Ensure that the staff is adequately trained to meet the quality standards and forecasted workload.
  • Monitors and records subsequent performance to assess the effects of training on efficiency.
  • Communicates staff increase and equipment needs to HQ.
  • Oversee the transportation, scheduling and recruitment departments.
  • Manage site workflow and processes.
  • Coordinate ordering office supplies for the sites as needed.
  • Ensure adequate space is available at the sites for storage of study supplies and equipment.
  • Address any employee compliance issues or concerns as needed.
  • Assist with PSV and SIV scheduling for the sites.
  • Obtain signatures on regulatory documents as needed by coordinating with the regulatory department.

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