Req ID #: 108331
Horsham, PA, US, 19044
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.
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
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 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.
- 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
- 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
- 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.
Essential Duties and Responsibilities (continued)
POST IN-LIFE AND REPORT PREPARATION PERIODS:
- Assist in drafting methodology and deviation sections of
- 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
- File correspondence and other documents in central filing
- Prepare historical control data summaries for specialized
- Aid SD's in responding to completion memos from senior report
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
- Perform other related duties as assigned by Supervisor.
- Prepare End of Study e-mail and distribute to study teams.
- Education: Bachelor's degree (BS/BA) or equivalent, preferably
in a life science.
- Experience: One or more years experience in a GLP laboratory
- 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 and Work Environment
- 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
- Must be able to regularly read and transcribe typewritten or
handwritten information into a personal computer and make edits on
- Regularly required to type for three to four hours at a
- Frequently files and retrieves information in four drawer file
- Regularly operates all office equipment.
- 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
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 300 investigational new
drug (IND) programs are conducted in our Safety Assessment
About Charles River
Charles River is an early-stage contract research organization
(CRO). We have built upon our foundation of laboratory animal
medicine and science to develop a diverse portfolio of discovery
and safety assessment services, both Good Laboratory Practice (GLP)
and non-GLP, to support clients from target identification through
preclinical development. Charles River also provides a suite of
products and services to support our clients' clinical laboratory
testing needs and manufacturing activities. Utilizing this broad
portfolio of products and services enables our clients to create a
more flexible drug development model, which reduces their costs,
enhances their productivity and effectiveness to increase speed to
With over 17,000 employees within 90 facilities in 20 countries
around the globe, we are strategically positioned to coordinate
worldwide resources and apply multidisciplinary perspectives in
resolving our client's unique challenges. Our client base includes
global pharmaceutical companies, biotechnology companies,
government agencies and hospitals and academic institutions around
the world. And in 2019, revenue increased to $2.62 billion.
At Charles River, we are passionate about our role in improving
the quality of people's lives. Our mission, our excellent science
and our strong sense of purpose guide us in all that we do, and we
approach each day with the knowledge that our work helps to improve
the health and well-being of many across the globe. We have proudly
supported the development of ~85% of the drugs approved by the FDA
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer -
If you are interested in applying to Charles River Laboratories
and need special assistance or an accommodation due to a disability
to complete any forms or to otherwise participate in the resume
submission process, please contact a member of our Human Resources
team by sending an e-mail message to crrecruitment_US@crl.com. This
contact is for accommodation requests for individuals with
disabilities only and cannot be used to inquire about the status of
For more information, please visit www.criver.com.
Nearest Major Market: Philadelphia
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