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: https://www.sarepta.com/join-us
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 collectionsLaboratory site evaluations, initiations and training coordination and troubleshootingFacilitate sample logistics and manage clinical sample chain of custodyCoordinate with sample management teams at Sarepta and third-party labs on sample shipments and timelines for analysisAssist with ordering and tracking of clinical trial suppliesPeer QC activities of clinical trial sample documentation and maintenance of organized files for assigned studiesDirect contact for GTCOE cross functional teams related to clinical trial activitiesAttend clinical trial team meetings for assigned studies and communicate relevant information to and from GTCOE teams involved in clinical trial conduct and analysisEnsure compliance with GCP/ GLP guidelinesCoordinate training for biopsy surgical sites including revision, distribution and tracking of SOPs and manualsSupport virtual and onsite meetingsTrack and assemble training documentation and certificationsSupport communications and build relationships with key stakeholders including CROs, vendors and clinical trial site staffGather and appropriately file documents in eTMFDraft, review, and route relevant documents related to biopsy analysis, lab specifications, blinding plans, etc.More about You
B.S. degree in related field3+ years of clinical trial operations or research operations experienceAbility to exercise discretion and judgment in handling confidential information and will follow FDA regulations, ICH guidelines and GCP in all tasksStrong organizational skills are required, as well as the ability to balance changing prioritiesDemonstrated technical proficiency and quality of sample handling with strict adherence to laboratory SOPsTrack record of solid teamwork and collaborationDesire to work in a dynamic, fast-paced team environment and to make a difference in the lives of people through our innovative medicinesDemonstrates the ability to communicate clearly across multiple parties, problem solve complex issues, and develop new training material and/or proceduresExcellent technical writing and communication skills; able to articulate technical concepts to diverse functional groups and external stakeholders.This position will require on-site activitiesPosition may include some domestic travelWhat 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.