Perform the collection, preparation and distribution of information necessary for protocol development and study initiation for all levels of studies. Assist the Study Director during in- and post-life by providing and coordinating scientific and administrative support and in the production of a high quality, accurate and timely study report. Assist in mentoring and training other Study Coordinators.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Prepare study-specific protocols consistent with the requirements of the Sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs.
•Prepare schedules for study-specific protocols; review schedules for consistency with laboratory scheduling system and update the schedule as required.
•Distribute draft protocols for internal/Sponsor review, coordinate protocol finalization process, and distribute and track distribution of final protocols and completed approval pages to the Sponsor, facility staff and subcontractors.
•Coordinate costing of study-specific protocols and protocol revisions with Client Services, ensure communication of study prices to the Sponsor with corresponding protocol drafts for approval, and ensure inclusion of necessary contract information with the final protocol when sent to the Sponsor.
•Coordinate revision of draft protocols in response to Sponsor requests, QAU audits and internal review, and prepare response letters to Sponsors documenting draft protocol revisions.
•Prepare and/or verify test article/substance and required analysis information with Formulations Department for inclusion in the protocol.
•Generate study timelines for study reports.
•Assist in notifying departments of new information or design changes for upcoming studies in a timely manner.
•Provide internal QC via peer review of protocols.
•Track availability and scheduled receipt of test article/substance shipments to ensure study start.
•Assist in any additional pre-study preparations as necessary (e.g., drafting new Standard Operating Procedures).
•Assist SD in communicating study status to the Sponsor, including timely communication of untoward study events (e.g., animal death) and generation of interim computer data summaries, along with a short summary of effects.
•Draft and ensure timely issue of protocol amendments, and assist in documentation of deviations from the protocol or SOPs.
•Prepare animal usage reports at end of study (for USDA reporting).
•Monitor key study events and notify study team members of upcoming events, including but not limited to, shipments to Sponsors/subcontractors and special/unusual data collections.
POST IN-LIFE AND REPORT PREPARATION PERIOD:
•Draft methodology and deviation sections of reports. Provide internal QC via peer review of methods sections of reports.
•Respond to audits of methodology, deviation and result report sections, and respond to or route questions appropriately for audits of other report sections.
•Review Sponsor requests for changes to the draft or final reports and route tasks to appropriate personnel.
•Draft results for pilot letter reports.
•Review result section of reports for accuracy, consistency with accepted company or sponsor style requirements.
•Prepare historical control data summaries for specialized data.
•Review draft report tables.
•Draft results for full study reports.
ALL STUDY PERIODS (GENERAL):
•Prepare for, attend, and/or lead Pre-study and End–of-Study Meetings as required.
•Attend scheduled study meetings.
•Contact subcontractors as necessary to clarify study requirements or facilitate scheduling or revisions of reports.
•Gather data/information to fulfill special Sponsor requests.
•May provide guidance and training to other Study Coordinators.
•Assist with group scheduling and administration.
•Assist with Sponsor and Agency audits.
•Act as back-up to the Study Director during Sponsor site visits.
•Assist with Sponsor visits.
•Perform other related duties as assigned by Supervisor.Qualifications
•Education: Bachelor’s degree (BS/BA) or equivalent, preferably in a life science.
•Experience: Three to 4 years experience in a GLP laboratory environment.
•An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•Other: Demonstrates competency with Study Coordinator II requirements (or equivalent experience).
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet