Job Description
Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We're looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website:
The Importance of the Role Sarepta Therapeutics is seeking a motivated Research Associate II ideally with experience working in a GCP/GLP environment for a clinical research operations support role. This position will collaborate with both internal and external stakeholders in planning, execution, and management of clinical sample logistics and clinical trial operations with a focus on specialty labs, biomarker, and immunology sample testing. This position will support site training, site feasibility activities, and oversight related to the transfer of samples from collaborators, vendors and CROs to Sarepta and third-party facilities. Working closely with the clinical operations, data management, translational, biomarker, and immunology R&D teams, this position will support the training of domestic and international biopsy surgical and laboratory sites, distribution of training materials related to sample management and maintain training documentation records.
The Opportunity to Make a Difference - Support training of clinical sites on biopsy and/or specialty lab collections
- Laboratory site evaluations, initiations and training coordination and troubleshooting
- Facilitate sample logistics and manage clinical sample chain of custody
- Coordinate with sample management teams at Sarepta and third-party labs on sample shipments and timelines for analysis
- Assist with ordering and tracking of clinical trial supplies
- Peer QC activities of clinical trial sample documentation and maintenance of organized files for assigned studies
- Direct contact for GTCOE cross functional teams related to clinical trial activities
- Attend clinical trial team meetings for assigned studies and communicate relevant information to and from GTCOE teams involved in clinical trial conduct and analysis
- Ensure compliance with GCP/ GLP guidelines
- Coordinate training for biopsy surgical sites including revision, distribution and tracking of SOPs and manuals
- Support virtual and onsite meetings
- Track and assemble training documentation and certifications
- Support communications and build relationships with key stakeholders including CROs, vendors and clinical trial site staff
- Gather and appropriately file documents in eTMF
- Draft, review, and route relevant documents related to biopsy analysis, lab specifications, blinding plans, etc.
More about You - B.S. degree in related field
- 3+ years of clinical trial operations or research operations experience
- Ability to exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasks
- Strong organizational skills are required, as well as the ability to balance changing priorities
- Demonstrated technical proficiency and quality of sample handling with strict adherence to laboratory SOPs
- Track record of solid teamwork and collaboration
- Desire to work in a dynamic, fast-paced team environment and to make a difference in the lives of people through our innovative medicines
- Demonstrates the ability to communicate clearly across multiple parties, problem solve complex issues, and develop new training material and/or procedures
- Excellent technical writing and communication skills; able to articulate technical concepts to diverse functional groups and external stakeholders.
- This position will require on-site activities
- Position may include some domestic travel
What Now? We're always looking for solution-oriented, critical thinkers.
So, if you're comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
#LI-Onsite
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This position requires work on site at one of Sarepta's facilities in the United States.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
Job Tags
Full time, Remote job,