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About the Role

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

Responsibilities

• 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

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 that takes initiative
• Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within organization
• Proficient written and verbal communication skills
• Candidates must be authorized to work in the U.S.

Location

• USA

Work Type

• Remote
• Hybrid

Experience Level

• 4+ years’ experience in a clinical research related position

Education Level

• Bachelor’s degree in life sciences or healthcare related field

Salary/Compensations

• $107,200 - $134,000 per year

Benefits

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers
• Competitive compensation and benefit package

About the Company

• 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.

Equal Opportunity

• Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.