Contract Nonclinical Safety Scientific Coordinator

The contract Scientific Coordinator will support the Nonclinical Safety Study Directors and Pathologist during the course of Nonclinical Safety and other studies. A primary role of the contract Scientific Coordinator will be to assist the study directors and pathologist in ensuring the GLP compliance requirements are maintained and to perform the more administrative aspects of study-related activities, as described below. The ideal candidate for this position has a passion for life sciences research and is a well organized and detail oriented problem solver. This position allows for extensive cross-team interface and collaboration on a variety of gene therapy, gene editing, and RNA projects.
Primary Responsibilities Include:

• Assist with administrative and scientific aspects of Nonclinical Safety study and pathology study execution by serving as the point person for communication between Nonclinical Safety study directors and resource groups (e.g. the vivarium, functional outcomes, necropsy, and histology teams).
• Participate in project coordination and timeline/workload management activities including study and deliverable tracking to ensure on time delivery of study deliverables and reports.
• Assist with pre-inlife and post-inlife aspects of Nonclinical Safety and pathology studies including IACUC submissions, study protocol preparations and review, review of project calendars, participation in pre-study meetings, completeness checks of ongoing project activities, and organization of incoming data/slides/forms arriving from internal and external sources.
• Interact with the quality control (QC) and quality assurance (QA) groups to ensure timely completion of QC and QA reviews of study phases, data, and reports.
• Ensure timely and accurate preparation of Provantis for data collection to include review of the Provantis Protocol Definition. For pathology-only studies in Provantis, the Scientific Coordinator will be responsible for study set-up.
• Complete Provantis table and statistical analysis generation under the direction of Nonclinical Safety study directors and/or the pathologist. Assist with Provantis data transcription as necessary.
• Prepare study-specific forms and labels for use in Nonclinical Safety studies.
• Assist in the preparation of toxicology and pathology reports and other deliverables, including setting up templates, performing informal quality control review, incorporating tables, arranging/organizing digital images, and light desktop publishing.
• Assist with end of study activities including CTD table generation, SEND file review, and archival of study materials.
• Conduct other project-related tasks with guidance as directed

Desired Education and Skills:

• Bachelor's Degree (BS/BA) or equivalent in biology, zoology, animal science, chemistry, pathology, or a related life sciences field.
• Minimum of 2 years of relevant experience in the conduct of nonclinical animal studies, preferably including pathology endpoints.
• Proficiency with typical corporate software, including Microsoft Word, Microsoft Excel, and Adobe Acrobat. Prior experience with of Provantis (Instem®) software is desirable but not required.
• Excellent verbal and written presentation and inter-personal skills.
• Experience in a Good Laboratory Practices (GLP) environment is desirable but not required.

This position requires significant animal handling or contact with substances that may result in sensitization to allergens or exacerbate pre-existing allergies. In light of this, Sarepta requests that individuals not apply for this position who have known allergies to mice or rats or animal dander generally. Individuals with allergies to any of the previously named species of animals may be deemed unsuitable for this job
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