Sarepta Therapeutics is seeking a motivated Senior Research Associate with experience working in a GCP/GLP environment for a clinical research operations support role. The team member will collaborate with both internal and external parties in planning, execution and management of sample logistics, analysis, and day to day operations. This position will support training of clinical sites and coordination and resolution of issues related to the transfer of samples from collaborators, vendors and CROs to Sarepta and third-party specialty lab 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 Sarepta Clinical Operations and Translational Biology 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, he/she will maintain a site and sample tracking database system and assist with vendor management for specialty lab vendors.
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 assist with clinical sample reconciliation efforts
-
Manage and oversee sample management process development and implementation of centralized database for clinical samples and consent tracking
-
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 related to clinical analyses
-
Assist with budget forecasting for activities with external vendors and CROs
-
Assist with tracking of departmental metrics as applicable
Desired Education and Skills:
-
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
#LI-TG1
#LI-Hybrid
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
The targeted salary range for this position is $76,000 - $95,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
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.