What if you could repair broken genes? That is the question we ask ourselves at Editas Medicine. We’re focused on translating the power and potential of the CRISPR/Cas9 and CRISPR/Cpf1 (also known as Cas12a) genome editing systems into a robust pipeline of medicines for people living with serious diseases around the world. Our goal is to discover, develop, manufacture, and commercialize transformative, durable, precision genomic medicines for many diseases. We’re looking for talented, dedicated, passionate people to join our team and help us pioneer this field and do big, bold things that have never been achieved before. Are you full of hope, possibilities, and a belief that, working together, we can truly revolutionize the development of medicines to help patients around the world? If the answer is yes, then Editas Medicine is the place for you.

Key Responsibilities & Accountabilities:

• Supports the clinical team in the overall management of studies, including planning, execution and closeout of one or more clinical trials
• Assists with site management activities, including review of monitoring reports and tracking of site visits
• Communicates effectively with internal and external study personnel (investigative staff, vendors, CROs etc)
• Supports the project team with planning and preparation for investigator meetings and conferences
• Assists the study team with preparation of external and internal documentation for assigned trials and provides study status updates as requested
• Participates in vendor identification and management (e.g., CROs, IVRS, Central Labs, etc) as needed
• Assists with the development of vendor and site budgets and supports invoice and budget activities

• Has ownership of updating internal and external systems in a timely manner (CTMS, clinicaltrials.gov) and the maintenance of the Trial Master File
• Maintain site, vendor, team, and other contact lists and assists with the management of tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up to date
• Drive and prepare a quality response to regulatory authorities by coordinating all cross functional departments to ensure on time completion.

• Participates in clinical operations initiatives and programs as assigned
• Identifies, addresses and communicates quality and compliance concerns to the Sr. Director Clinical Quality
• Assist in development of study tools, guidelines, and training materials to support effective and accurate execution of clinical trial activities

• Attend and provide support in meeting scheduling and distribution of meeting agendas/minutes
• Assist the study team with review all site regulatory packages during study start-up to approve for Investigational Product release
• Assist the data manager with data monitoring such as tracking of SAEs and protocol deviations as needed
• Supports the management of tracking, logistics and quality operations for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up-to-date
• Communicate with management and clinical trial teams to ensure transparency throughout the course of the trial(s) regarding study metrics and overall status

• Review study plans and other clinical documentation
• Communicate with study sites regarding regulatory, start up and enrollment activities
• Provide oversight of CROs
• Coordinate and track site training for vendor specific study tasks
• Drive and manage clinical operations vendor deliverables
• Interface with CMC for shipment of drug to site pharmacies
• Receives minimal guidance and works independently
• Develop patient facing recruitment materials
• Develop work instructions for site staff
• Contribute to department documentation such as forms, templates, SOPs
• Prepare of protocol amendments for submission to IRBs, update effected study documents to align with changes submit to CRO for distribution to sites
• Prepare responses to IRB questions
• Identify, address, and escalate (potential) obstacles to project timelines, cost, and quality
• Tracking of regulatory submissions, drug shipment, enrollment of subjects, regulatory document flow, site start up tasks, contracts, and invoicing information
• Update SOWs for vendors as needed
• Creation of storyboards to document study issues
• Coordinate IDMC interactions through communication with CRO
• Coordinate stakeholders from closely related functions

Knowledge, Skills & Capabilities:

• Advanced skills in Microsoft Office programs as well as good working knowledge of electronic data systems
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• Excellent teamwork, communication (verbal and written), organizational, and interpersonal skills
• Self-motivated, proactive, and able to prioritize and manage multiple projects simultaneously

• Demonstrates well-developed instincts and problem-solving skills
• Detailed and precise record keeping skills are essential as well as the ability to track and resolve issues
• An understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
• Experience in Hematology/Oncology, Neurology, Immunology, Ophthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy
• Experience with phase 1-3 clinical drug development trials
• Strong communication, organizational and interpersonal skills are required
• Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities

Education & Relevant Work Experience:

• BA/BS degree required
• 1-3 years’ experience in the biotech industry and clinical drug development or clinical trial execution

Physical & Travel Requirements:

~10% travel on average- for IMs, site visits, and other team meetings

Benefits Summary:

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.