Senior Clinical Trial Associate
Sarepta Therapeutics is focused on developing first-in-class RNA-based therapeutics to improve and save the lives of people affected by serious and life-threatening rare and infectious diseases. The Company’s diverse pipeline includes its lead program eteplirsen, for Duchenne muscular dystrophy, as well as potential treatments for some of the world’s most lethal infectious diseases. Sarepta aims to build a leading, independent biotech company dedicated to translating its RNA-based science into transformational therapeutics for patients who face significant unmet medical needs. For more information, please visit us at www.sareptatherapeutics.com.
The Senior Clinical Trial Associate (CTA) supports the Clinical Operations department in the planning, execution and management of in-house or outsourced clinical trials. The Senior CTA will review, track and file study specific documents as well as create and update study specific reports. He/she must 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.
Primary Responsibilities Include:
•Collect, file and/or track clinical trial associated regulatory documents.
•Coordinate and track the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports etc.
•Maintain and ensure all documentation is in a state of audit readiness.
•Creation and maintenance the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs.
•Assist in the preparation of study related documents, i.e. ICF, clinical trial tools & templates etc.
•Support drug supply planning and defining supply logistics.
•Coordinate and track or supervise drug supply.
•Coordinate and track clinical trial equipment and supplies.
•Review and track vendor invoices against contracts and coordinate approval.
•Assist with site budget process.
•Act as central point of communication for trial team as well as study sites and vendor personnel.
•Responsible for sending and tracking all safety letters to Investigators according to timelines provided by Clinical Trial Manager.
•Support the trial team to produce and distribute study newsletters.
•Assist in the coordination of Investigator Meetings.
•Create agendas and record team meeting minutes under the direction of the Clinical Trial Manager.
•Assist the Clinical Trial Manager with timeline maintenance.
Education and Skills Requirement:
•Bachelor’s degree in life sciences or healthcare related field
•2+ years’ experience in a clinical research related position
•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 expected.
•A team player that takes initiative is a must.
•Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
•Proficient written and verbal communication skills.
•Position may require some travel.
Sarepta is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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.