Clinical Operations Intern
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Clinical Operations Intern

Selecta Biosciences is leveraging its ImmTOR® platform to bring hope to the over 24 million Americans suffering from autoimmune disease daily. ImmTOR and ImmTOR-IL (our next generation immunotherapy platform) have the potential to restore the body’s natural self-tolerance in autoimmune diseases, amplify the efficacy of biologic therapies and unlock the true potential of life-saving gene therapies.
To support our ambitious pursuits, the Clinical Operations Intern will produce timely and accurate data reconciliation and QC for the Clinical Operations team.


Principal Duties/Responsibilities:
• Reconciliation of Monitoring Visits (MVs) and MV Trip Reports (TRs)
• Reconciliation of Site Issues Report against MV TRs to confirm/facilitate resolution of issues
• Review Protocol Deviation (PD) Reports and confirm if deviations are appropriately captured in MV TRs, and confirm submission to IRBs if applicable
• Identification of overdue data queries and follow-up with CRAs to facilitate closure
• QC and review of electronic Trial Master Files (eTMFs)
• High level review of EDC data (for example: confirmation of number of days a dosing visit was OOW and checking if protocol deviation was noted appropriately)
• Data Reconciliation and QC across systems (eg. eDC, IRT, lab portal, etc.)
• Assist team as needed with study-related activities in preparation for database lock (DBL) and end of study (EOS) deliverables

Desired Experience and Capabilities
• Working toward a B.S. or B.A. in health care or scientific discipline degree preferred
• Must have strong computer skills working with Microsoft office programs (Word, Excel, PowerPoint, Outlook, and Microsoft Project)
• Excellent written and verbal communication
• Strong attention to details and organizational skills
• Excellent teamwork and collaborative skills


Work Environment
The function of the role and where the day-to-day completion of the related tasks take place is flexible. Successful applicants will be able to function throughout the office environment and remotely. Responsibilities include a work schedule that can require working outside of “normal” work hours, to meet business demands.

Selecta is an Equal Employment Opportunity employer of Minorities, Females, Disabled Individuals, and Veterans (M/F/D/V).