Editas Medicine Clinical Operations Associate, Clinical Compliance and TMF Oversight in Cambridge, Massachusetts
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
Experience with eTMF systems
3+ years of experience in clinical research at either an academic institution, Pharma/Biotech company, or CRO
Understanding of ICH/GCP and regulations around clinical research
Flexibility to adapt to the dynamic needs of a growing organization
Must work with a sense of urgency, be able to work autonomously and as part of a team
Must have excellent communication, problem solving, and organizational skills
Additionally, candidates with the following attributes are preferred:
CRA experience or CRO oversight experience strongly preferred
Experience using Veeva QMS
Inspection experience highly desirable
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.