Study Coordinator Supervisor

Study Coordinator Supervisor

The Study Coordinator Supervisor will supervise the coordination and administration of all aspects of ongoing studies including planning, organizing, staffing, and leading program activities. This role will also work as part of a team conducting routine procedures required for study conduct, interacting and communicating with clients, study directors, and technicians in a cross-functional, flexible, and collaborative spirit.

Study Coordination

• Perform periodic review of all applicable SOPs to ensure accuracy and confirm procedures are being performed according to SOPs. Participate in SOP writing, reviews, and revisions, as needed
• Maintain and submit study initiation materials
• Communicate effectively with all key stakeholders including vendors and clients
• Order all applicable supplies for studies
• Communicate with other coordinators to schedule study activities
• Insure creation of data sheets
• Confirm lab math for test article and disease induction formulation
• Communicate with formulation department regarding timeline and materials needed
• Assist with in-life study conduct, as needed, and as trained
• Complete training requirements as assigned and maintain appropriate training documentation
• Maintain compliance with all policies and procedures
• Ensure compliance with USDA, AAALAC, OLAW and other applicable regulations
• Perform quality checks, reviews, and formatting on all Inotiv documents (e.g., protocols, amendments, deviations, reports, tables, etc.)
• Develop and maintain protocol, report, and data table master templates
• Provide back-up support for Study Directors as needed
• Aid in protocol and any protocol amendment or deviation preparation and distribution
• Prepare and review raw data collection forms and review for adherence to protocol, both prior to study start and after study completion
• Review raw data collection and in-life study conduct
• Assist to prepare a complete study file for archival following finalization of report
• Assist to ensure that study samples and test articles are shipped appropriately, on schedule, and documented in the study file
• Perform other duties as assigned

Leadership and Supervision

• Train Study Coordinator personnel to ensure staff can support workflow demands.
• Relay critical updates and procedural changes to other coordinators and other relevant team members.
• Serve as a central point of contact for Study Coordinator issues and team feedback.
• Manage and distribute study workload among Study Coordinators to ensure equitable distribution of tasks.
• Allocate resources as necessary based on department demands.
• Verify study entries and schedules for accuracy.
• Manage corrections for scheduling errors, including oversight of handwritten activities and missing schedule entries.
• Provide oversight during the scheduling of studies.
• Manage schedules, including adjustments for weekend and holiday staffing.
• Maintains proper retention of scheduling documents according to SOP.
• Standardize coordinator processes to ensure consistency across study work.
• Contribute to process improvement and overall team operations.
• Lead weekly coordinator meetings with reports.
• Provides regular coaching feedback to team member on performance.

Education and experience

• Bachelor's degree in life sciences or other directly related field or degree with comparable coursework and a minimum of 5+ years in a relevant pharmaceutical setting
• Prior management experience preferred
• Possess strong skills for editing the format, style and language of draft protocols, spreadsheets and reports
• Experience using Microsoft Office (Word, Excel, Outlook), Pristima or Provantis experience a plus

Skills and abilities

• Individuals must demonstrate strong communication skills and be able to work efficiently in individual and team settings.
• Excellent written and verbal communication skills
• An attitude for quality, an eye for detail and the ability to read and follow written instructions
• Ability to interact and collaborate with scientific staff at all levels

Performance Requirements

• Able to work overtime, as needed

Working Conditions & Physical Requirements

• Extended computer and display screen equipment usage
• Ability to push, pull, lift 5 pounds unassisted.
• Stand / walk for extended period of time.
• Ability to read and interpret materials, verbally communicate, and hear required.

• Customer Focus. Identifies, prioritizes and anticipates customer needs and delivers relevant, value-add, solutions to meet and exceed them
• Results Driven. Internal drive toward action to efficiently, timely, and accurately achieve results. Sets high but achievable standards for self and others. Seeks opportunities to improve process and outcomes. Constantly reviews performance to identify areas to develop.
• Efficient. Takes responsibility for own time and effectiveness. Identifies what needs to be done and does it before being asked or before the situation requires it. Able to work things out without having to be shown too often. Seeks…