Study Coordinator Supervisor

Supervise the coordination and administration of all aspects of ongoing studies, including planning, organizing, staffing, and leading program activities. 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.

Responsibilities

• 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.
• Ensure 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.
• Maintain 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.
• Provide regular coaching feedback to team members on performance.

Requirements

• Bachelor's degree in life sciences or other directly related field or degree with comparable coursework.
• 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

• Strong communication skills and ability to work efficiently in individual and team settings.
• Excellent written and verbal communication skills.
• 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 periods of time.
• Ability to read and interpret materials, verbally communicate, and hear required.

Critical Success Factors

• 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 opportunities to contribute appropriately without direction.
• Communication: Able to communicate information and ideas clearly and articulately both in oral and written form. Uses appropriate language, style, and methods depending on audience and the purpose of communication. Able to convey complex information clearly. Anticipates the information that others will need. Expresses ideas effectively. Practices attentive and active listening.
• Collaboration: Actively supports and contributes to the success of the team. Actively encourages and practices collaboration and cooperation on the team. Shares information and supports other team members. Can get things done with and through others and set realistic objectives. Seeks opportunities to develop others.
• Relationship Builder: Develops, maintains, and strengthens strong partnerships with others internally and externally, cross-functionally, in person and remotely.
• Critical Thinking and Problem Solving: Able to identify and separate out the key components of problems and situations. Able to manipulate and interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this. Can generate a range of creative solutions, evaluate, and choose the most appropriate option.
• Improvement Driven: Inspires and generates new solutions and approaches to issues and challenges to maximize efficiency and effectiveness through everyday practice of root cause analysis and critical thinking problem solving. Continually works to refine skills and abilities. Builds on ideas of others to come up with new ways to address issues or problems. Generates creative new solutions and approaches to issues and processes.
• Organization and Time Management: Plans and prioritizes work, manages time appropriately to meet deadlines, follows up with others to ensure one’s own work and commitments are completed on time, deals with pressure and deadlines through good planning.

Pay

$72,000 - $89,000 adjusted according to the level of the role and the candidate’s relevant experience and/or education.

Benefits

• Health and dental coverage
• Short- and long-term disability
• Paid time off
• Paid parental leave
• 401(k)