Senior Clinical Trial Associate

Senior Clinical Trial Associate, Clinical Operations

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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.

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

The Senior Clinical Trial Associate, Clinical Operations is an advanced professional who supports in the planning, execution, and management of clinical trials.

The Opportunity to Make a Difference

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF's, monitoring visit reports, etc.
• Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
• Performs quality checks on the study TMF with oversight of study Clinical Operations Lead (COL)
• Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc.
• Coordinates and tracks clinical trial equipment and supplies
• Coordinates and tracks shipments of drug supply
• Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead
• Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation
• May support and participate in departmental/cross-functional process improvement initiatives
• Supports the trial team to produce and distribute study newsletters
• Supports collection and updating of clinical trial insurance
• Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
• Serves as point of contact for 1 or more low to medium complexity vendors with oversight of study Clinical Operations Lead
• Liaises with clinical trial sites as required
• May assist in the coordination of Investigator Meetings and potentially present content
• May assist the study Clinical Operations Lead with timeline maintenance and may lead smaller cross-functional team meetings with oversight of study Clinical Operations Lead
• May support additional ad-hoc activities as agreed with the study Clinical Operations Lead

More about You

• Strong computer skills including knowledge of Excel, Word, PowerPoint and Outlook
• Solid understanding of the responsibilities and needs of other functions in a clinical trial
• Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
• Ability to maintain confidentiality of proprietary information
• A team player that takes initiative
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within organization
• Proficient written and verbal communication skills
• Position may require some travel
• Bachelor's degree in life sciences or healthcare related field
• 4+ years' experience in a clinical research related position
• This role is remote in the USA with approximately 10% travel (once per Quarter)

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.