Sarepta Therapeutics is seeking a motivated Senior Research Associate with experience working in a GCP/GLP environment for a clinical and/or research operations support role. The team member will collaborate with the internal and external associates in planning, execution and management of sample logistics, strategy, and operations. This position will support process development, training and oversight related to the transfer of samples from collaborators, vendors and CROs to Sarepta and third-party facilities. Further, they will oversee and coordinate training of less-experienced staff on GCP/COC and laboratory processing related to sample handling and management tasks. Working closely with the clinical operations and research teams, the team member 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. Additionally, this person will maintain the site and sample tracking database system (Zudy, etc) and assist with budget and invoice tracking and organization of SOWs and POs.
Primary Responsibilities include:
- Support training of clinical sites to allow enrollment of patients in Sarepta Muscular Dystrophy studies
- Laboratory site initiations and training coordination
- Facilitate sample logistics and manage clinical sample chain of custody
- Manage and oversee sample management process development, SOW's and PO's
- Sample and database management
- Assist with coordination and tracking of clinical trial supplies
- QC activities of clinical trial sample documentation
- Direct contact for the CTM's related to clinical trial activities
- 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 training meetings, track and assemble training documentation and certifications
- Collaborate with Clinical Operations, Data Management, Biostatistics and vendors for data transfer and analysis needs
- Support communications and build relationships with key stakeholders including CROs, vendors and external collaborators
- Assist laboratory teams with writing and reviewing SOPs, reports, publications
- Assist with budget and invoice tracking for activities with external vendors and CROs
- Support setting up and tracking of new contracts and change orders to existing contracts
- Assist with tracking of departmental metrics
- Support tracking of assay development and validation activities
- This position will cover both non-clinical and clinical interactions with internal and external collaborations
- Desired Education and Skills Requirements:
- B.S. degree in Biology, Biochemistry, or related field and 5+ years hands-on clinical sample management or research operations experience in biotech or healthcare setting working in a GCP/GLP environment.
- 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 complex technical concepts to diverse functional groups and external stakeholders.
- This position will require on-site activities
This position requires work on site at one of Sarepta's facilities in the United States. Candidates should be aware that Sarepta currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 in order to work on site. Newly hired employees must be vaccinated prior to their employment start date. Sarepta is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
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.