For 70 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.IMPORTANT:
In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.
Please make sure work history and education are added correctly. Job Summary
Provides administrative support to Study Directors for management of data and preparation of protocol/study plans and study reports and assists with providing requested data/information. May also assist with management of Quality Assurance (QA) audits. Job Qualifications
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Attending study-related and/or department-related meetings to assure understanding of assigned projects including objectives, timelines, and reporting requirements.
- With guidance from Study Directors, assists in generating drafts Study Plans/Protocols and amendments and may facilitate signature/approval process for study plans/protocols, amendments, and other required forms or documents.
- Verifies documents against any client-specific requirements indicated in Client Information Database (CID).
- May assist in initial preparation of animal ethical project review summary.
- Extract data for preparation of Sponsor updates.
- Create/generate special tables/graphics as support for Sponsor/Study Director, as needed. This may be performed in support of toxicology studies and/or as support for PI/IS contributing reports.
- Assists with drafting of materials & methods sections of reports.
- Performs Quality Control (QC) of draft reports and Common Technical Documents (CTD).
- Assists with management of QA audits, may answer QA audit findings and assures necessary corrections as directed by the Study Director.
- May assist in documentation of deviations from the protocol/study plan or Standard Operating Procedures (SOP).
- Involved or responsible for tabulation of study data.
- May help schedule data review meetings.
- May assembles report (text and data tables) for Study Director review, QA audits, and final report compilation.
- May assist in obtaining Sponsor approvals for finalization of documents (e.g., protocols/study plans and/or reports).
- May assist in documentation of deviations from the study plan/protocol or Standard Operating Procedures (SOP).
- May attend scientific meetings, conferences or training courses to enhance job and professional skills.
- Performs all other related duties as assigned.
IMPORTANT: A resume is required to be considered for this position.
- Education: Bachelor's degree (BA/BS) in Toxicology, Pharmacology or related field - required.
- Experience: No work experience required.
If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.Vaccine Mandate
Charles River is a U.S. Federal Contractor. As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021. Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.About Safety Assessment
Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.