Senior Clinical Trial Associate

Why Sarepta?

Sarepta is at the forefront of genetic medicine, holding a leadership position in Duchenne muscular dystrophy (Duchenne) and building a robust portfolio across muscle, central nervous system, and cardiac diseases. In 2023, Sarepta launched its fourth therapy and the first-ever gene therapy to treat Duchenne. We seek individuals who see unlimited potential in themselves and are motivated by an unwavering commitment to patients.

What Sarepta Offers

Sarepta is committed to supporting employees in all aspects of their lives, fostering a culture where people bring their whole selves to work. We offer a range of benefits and work-life resources, including:

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

For a full list of comprehensive benefits, visit our website.

About the Role

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

Responsibilities

• Coordinates and tracks the distribution and retrieval of clinical documents, including protocols, protocol amendments, IBs, ICFs, and monitoring visit reports.
• Supports maintenance of an inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs.
• Performs quality checks on the study TMF with oversight from the study Clinical Operations Lead (COL).
• Assists in preparing study-related documents, such as ICFs, clinical trial tools, and templates.
• Coordinates and tracks clinical trial equipment, supplies, and drug shipments.
• Reviews and tracks vendor invoices against contracts with oversight from the study Clinical Operations Lead.
• Coordinates administrative aspects of contract execution and Purchase Order (PO) generation.
• May support and participate in departmental or cross-functional process improvement initiatives.
• Supports the trial team in producing and distributing study newsletters.
• Supports collection and updating of clinical trial insurance.
• Assists with meeting management, including agenda distribution and minute-taking, internal database maintenance, and study team contact lists.
• Serves as the point of contact for one or more low-to-medium complexity vendors with oversight from the study Clinical Operations Lead.
• Liaises with clinical trial sites as required.
• May assist in coordinating Investigator Meetings and potentially present content.
• May assist the study Clinical Operations Lead with timeline maintenance and lead smaller cross-functional team meetings with oversight.
• May support additional ad-hoc activities as agreed with the study Clinical Operations Lead.

Requirements

• Strong computer skills, including proficiency in 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 handle multiple priorities in a fast-paced environment.
• Ability to maintain confidentiality of proprietary information.
• Team player with initiative, excellent interpersonal skills, strong organizational skills, and effective communication across all levels.
• Proficient written and verbal communication skills.
• Bachelor’s degree in life sciences or a healthcare-related field.
• 4+ years of experience in a clinical research-related position.
• Position may require some travel.

Schedule

This role is remote in the USA with approximately 10% travel (once per quarter). The position is hybrid, requiring occasional on-site work at one of Sarepta’s U.S. facilities and attendance at Company-sponsored in-person events.

Pay

The targeted salary range for this position is $107,200 - $134,000 per year. The salary offer is commensurate with education, training, experience, external market conditions, role criticality, and internal equity.