Study Coordinator 1

Job Summary

Full Time - Hybrid

BASIC SUMMARY:  Perform the collection, preparation and distribution of information necessary for protocol development and study initiation for studies on basic levels of studies under the supervision of a study director, principal investigator and/or supervisor of study coordination. 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. 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  PRE-STUDY PERIOD: Assist in preparation of study-specific protocols consistent with the requirements of the Sponsor, laboratory SOPs and applicable government and regulatory body guidelines and GLPs. Assist in the preparation of 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 revision of draft protocols in response to Sponsor requests, QAU audits and internal review, and prepare response letters to Sponsors documenting draft protocol revisions. Generate Telstar 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. Perform all other related duties as assigned.  IN-LIFE PERIOD: 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. Assist in drafting and ensuring a 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 PERIODS: Assist in drafting methodology and deviation sections of reports. Assist in responding to audits of methodology, deviation and result report sections, and responding to or routing questions appropriately for audits of other report sections. Edit, format and compile assigned reports for final issue as assigned by Supervisor. Review Sponsor requests for changes to the draft or final reports and route tasks to appropriate personnel. Responsible for tracking and processing revised draft final reports for finalization. Responsible for updating Sponsors request files for staff's use when preparing draft and final reports. Coordinate the generation and handling of electronic report format requests. Assist in evaluating new technologies for creating these formats. File correspondence and other documents in central filing system. Prepare historical control data summaries for specialized data. Aid SD's in responding to completion memos from senior report reviewers. ALL STUDY PERIODS (GENERAL): Prepare for and attend Protocol Meetings as required. Attend Telstar meetings as requested. Contact subcontractors as necessary to clarify study requirements or facilitate scheduling or revisions of reports. Gather data/information to fulfill special Sponsor requests. Perform other related duties as assigned by Supervisor. Prepare End of Study e-mail and distribute to study teams. Compile responses.

Job Qualifications

⦁    Education: Bachelor's degree (BS/BA) or equivalent, preferably in a life science. ⦁    Experience: One or more years experience in a GLP laboratory environment preferred. ⦁    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above. ⦁    Certification/Licensure: None Physical Demands: • While performing the duties of this job, the employee is regularly required to talk and hear. • Specific vision abilities required by this job include regular use of close vision and the ability to adjust focus. • Must be able to regularly sit approximately six hours a day. • Must be able to regularly read and transcribe typewritten or handwritten information into a personal computer and make edits on information therein. • Regularly required to type for three to four hours at a time. • Frequently files and retrieves information in four drawer file cabinets. • Regularly operates all office equipment. WORK ENVIRONMENT: • General office working conditions. The noise level in the work environment is usually quiet. • Occasionally works near toxic or caustic chemicals and test articles with unknown levels of toxicity. • May occasionally be required to wear protective clothing and equipment.