Study Coordinator Supervisor

Inotiv•Boulder, CO

4d•Onsite

About The Position

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.

Requirements

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)
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
Able to work overtime, as needed
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.

Nice To Haves

Pristima or Provantis experience a plus

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
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
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.