Clinical Trial Associate II

Sarepta Therapeutics•Cambridge, MA

5d•Hybrid

About The Position

The Clinical Trial Associate II, Clinical Operations is a developing professional who supports in the planning, execution, and management of clinical trials. Sarepta is on an urgent mission: engineer precision genetic medicine for rare diseases that devastate lives and cut futures short. 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. Our deep pipeline is driven by our multi-platform technologies in siRNA, RNA and gene therapy.

Requirements

Bachelor’s degree in life sciences or healthcare related field
3+ 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
Candidates must be authorized to work in the U.S.

Nice To Haves

Position may require some travel

Responsibilities

Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits 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
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
May coordinate and track shipments of drug supply
Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead
May support and participate in departmental/cross-functional process improvement initiatives
Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation
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.
May serve as point of contact for low complexity vendors with oversight of study Clinical Operations Lead
May support additional ad-hoc activities as agreed with the study Clinical Operations Lead