Support study execution by managing meeting logistics, documenting decisions, and tracking action items.
Partner with Clinical Operations and site monitors to ensure protocol compliance and quality standards are met.
Responsible for filing the site-level documents into the Trial Master Files (TMFs) in a timely manner.
Track, review, and organize essential documents from sites and vendors.
Identify, escalate, and help resolve site-level issues in collaboration with cross-functional teams.
Assist with regulatory submissions and other study deliverables.
Drive process improvements that enhance speed, quality, and patient impact.

Requirements

Bachelor’s degree in a life science or health-related field, or equivalent industry experience.
5+ years of clinical trial experience in biotech, pharma, or CRO settings.
Solid knowledge of GCP, ICH guidelines, and regulatory requirements.
Exceptional organizational and communication skills.
A proactive, problem-solving mindset with high attention to detail.
Comfortable managing multiple priorities in a fast-paced, mission-driven environment.
Strong team player who thrives in flat, agile organizations.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

Benefits

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial experienceregulatory submissionsprotocol compliancedocument managementprocess improvementsattention to detailproblem-solving

Soft Skills

organizational skillscommunication skillsproactive mindsetteam playerability to manage multiple priorities