Clinical Trials Associate

Description

At Viridian, we work with a sense of urgency for patients, creating unity with our team, the industry, and the community. We are committed to using proven science and engineering to improve the lives of people living with serious and rare diseases, and we are getting closer to achieving this goal every day.

Reporting to the Director, Clinical Operations, the Clinical Trial Associate is a critical member of the project team responsible for supporting the execution of clinical studies through the coordination and maintenance of study documentation, clinical systems, communications, and operational activities. This role partners closely with Clinical Operations team members to ensure study documentation is complete, accurate, and maintained in accordance with company SOPs, ICH-GCP guidelines, and applicable regulations.

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Support clinical studies from study start-up through closeout
• Maintain Trial Master Files (TMF) and support inspection readiness activities
• Assist with collection, filing, reconciliation, and archival of study documentation
• Coordinate study team meetings, agendas, minutes, and action items
• Maintain study trackers, metrics, and operational reports
• Support site communications and document exchange
• Assist with study startup activities, including collection of essential documents
• Support vendor onboarding and administrative study activities
• Maintain training records and associated study documentation
• Assist with audit and inspection preparation
• Support clinical systems utilized by study teams
• Participate in departmental process improvement initiatives
• Develop collaborative relationships with study team members and external partners
• Ensure activities are conducted in accordance with SOPs, regulations, and ICH-GCP guidelines

Requirements

• BA/BS degree in Health Sciences, Life Sciences, Nursing, or related discipline required
• 0-2 years of experience in Clinical Research, Clinical Operations, Healthcare, or related field
• Basic understanding of clinical research processes and ICH-GCP guidelines preferred
• Strong collaboration, communication, and interpersonal skills
• Reliable, self-motivated, team player
• Strong attention to detail with exceptional organizational skills
• Demonstrated strong written and verbal communication skills
• Ability to prioritize workload and manage multiple assignments
• Ability to work in a fast-paced environment
• Strong commitment to ethical standards
• Proficiency with Microsoft Office Suite (Word, PowerPoint, Excel, Outlook, Teams, SharePoint, etc.)
• Ability to travel up to 10%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision insurance
• 100% Paid Parental Leave
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various fertility, mental, financial, and proactive physical health programs

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.