Senior Clinical Trial Associate

Why Sarepta? Why Now? 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.

About the Role

The Senior Clinical Trial Associate, Clinical Operations is an advanced professional who supports the planning, execution, and management of clinical trials. This role coordinates and tracks clinical trial activities, ensures compliance with ICH-GCP and company SOPs, and liaises with vendors and clinical trial sites.

Responsibilities

• Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICFs, and monitoring visit reports.
• 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 the study Clinical Operations Lead (COL).
• Assists in the preparation of study-related documents, such as ICFs, clinical trial tools, and templates.
• 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 the 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, such as meeting management (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 of the 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.
• May support additional ad-hoc activities as agreed with the study Clinical Operations Lead.

Requirements

• 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 who takes initiative.
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within the organization.
• Proficient written and verbal communication skills.
• Bachelor’s degree in life sciences or a healthcare-related field.
• 4+ years’ experience in a clinical research-related position.
• Position may require some travel (approximately 10% travel, once per quarter).
• This role is remote in the USA but may require on-site work at one of Sarepta’s facilities in the United States and/or attendance at Company-sponsored in-person events from time to time.

Benefits

At Sarepta, we care deeply about all the people in our community and believe in supporting them in all aspects of their lives. We offer a range of benefits and work-life resources designed to support physical and emotional wellness, financial wellness, and support for caregivers.

For a full list of our comprehensive benefits, visit our website: https://www.sarepta.com/join-us.

Pay

The targeted salary range for this position is $107,200 - $134,000 per year. 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.