Clinical Operations Associate, Clinical Compliance and TMF Oversight
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
The Clinical Operations department is looking for a dynamic clinical compliance and TMF oversight associate to join a growing team! This role will focus primarily on TMF QC and oversight, Monitoring Oversight, SOP oversight as well as inspection readiness and inspection preparation activities.
- TMF Oversight: Responsible for the submission of internal documents to the Trial Master File (TMF); will coordinate Editas cross-functional quality review of the electronic TMF to ensure inspection-readiness
- Inspection Readiness Activities: Supports inspection preparation activities for mock inspections, internal audits, and FDA and other regulatory body meetings and inspections
- Monitoring Oversight: Assist with monitoring trip report review and oversight of CRO CRA activities. May perform monitoring oversight visits with CRO CRAs.
- SOP Oversight/Support: Assist with oversight of SOPs as well as support during development and revision of SOPs, Forms, Templates and Work Instructions to support the Clinical Medical Organization. May review CRO SOPs.
- May support development of critical study documents, study plans, TMF index, operational documents, study reference documents, and other related documents
- May assist in the coordination and tracking study-specific laboratory samples
- May review study-specific essential regulatory document packets to ensure adequate filing in TMF
- Work with key cross-functional stakeholders on filing of documents in TMF
- Communicates with CROs and other clinical vendors to meet deliverables
- Other responsibilities/support within Clinical Operations, as needed