Sr. Clinical Trial Associate

Location: Bedford, MA (Hybrid)

Therapeutic Area: Rare Disease

Job Overview: As a Senior Clinical Trial Associate, you will coordinate clinical trial logistics, support study planning and execution, and manage CRO and vendor activities. You’ll help maintain inspection-ready documentation and ensure timely delivery of clinical operations objectives.

Primary Job Responsibilities:

• Manage distribution and tracking of clinical documents (protocols, IBs, ICFs, etc.)
• Support Trial Master File (TMF) maintenance and quality checks
• Oversee CROs and vendors to meet study timelines and budgets
• Track development of key regulatory documents and submissions
• Assist with audit readiness and study-related materials
• Review meeting minutes and follow up on action items
• Maintain strong relationships with external partners
• Ensure documentation complies with GCP and protocol standards

Primary Job Requirements:

• 4+ years in clinical operations (biotech, pharma, or CRO)
• 2+ years supporting multiple clinical trials
• Strong knowledge of ICH-GCP and drug development
• Bachelor’s degree in a scientific or healthcare field preferred
• Proficient in Microsoft Office tools
• Excellent communication, organization, and problem-solving skills
• Comfortable in a fast-paced, collaborative environment

About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.