Study Coordinator I

3 weeks ago

Horsham, United States Charles River Laboratories Full time

**Req ID #**:223048**Location**:Horsham, PA, US, 19044- For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.**Job 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**
- 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 lab 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 study timelines for study reports.
- Assist in notifying departments of new information or design changes for upcoming studies
- Provide internal QC via peer review
- Assist SD in communicating study status to the Sponsor
- Monitor key study events and notify study team members of upcoming events
- 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.
- Prepare for and attend Protocol Meetings as required.
- Contact subcontractors as necessary to clarify study requirements or facilitate scheduling or revisions of reports.
- Gather data/information to fulfill special Sponsor requests.

**The pay range for this position is between $26.00 and $28.00 an hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.**

**Job Qualifications**

**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
- Other: 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.

**About Safety Assessment**
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-a

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