Clinical Trial Associate

Responsibilities

• Support the Clinical Study Lead and Clinical Operations team in the day-to-day operational activities of clinical trials to ensure study objectives, timelines, quality standards, and regulatory requirements are met.
• Support oversight of CROs, vendors, and investigator sites, including review of monitoring visit reports, site communications, and follow-up on study-related actions and issues.
• Maintain study tracking tools for key study documentation (e.g., Form FDA 1572) and operational activities, including site activation, enrollment, monitoring visit status, IRB/EC approvals, safety letter distribution, training compliance, and study milestones.
• Support Trial Master File (eTMF) activities, including document collection, filing, reconciliation, quality control reviews, and inspection readiness efforts.
• Support preparation of study agendas, meeting minutes, action item logs, and study status reports while ensuring effective communication across internal teams, CROs, vendors, and investigator sites.
• Collaborate cross-functionally with Regulatory Affairs, Clinical Supplies, Data Management, Safety, Quality, and other functional areas to support study deliverables and timelines.
• Manage study team training records and ensure compliance with applicable SOPs, regulations, study requirements, and company policies.
• Manage system access requests for study team and site personnel, as needed.
• Communicate and escalate study risks, protocol deviations, operational challenges, and other study-related issues as appropriate.

Requirements

• Bachelor’s degree in scientific or related field with 2+ years of experience in Clinical Operations, clinical research or healthcare, or equivalent experience.
• Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential.
• Demonstrated efficiency in partnering with CROs and vendors.
• Computer proficiency (Word, Excel, PowerPoint, Project).
• Works proactively and efficiently in a fast-paced, high change environment.
• Excellent interpersonal, written and verbal communication skills.
• Ability to interact well with various team members and provide value added support to projects.
• Outstanding organization skills.
• Strong analytical, strategic thinking, and problem-solving skills.
• Ability to quickly learn new tools, systems, and processes to improve efficiency.

Qualifications

• Education: Bachelor’s degree in scientific or related field.

Skills

• Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
• Experience in Clinical Operations, clinical research, or healthcare.
• Proficiency in computer applications (Word, Excel, PowerPoint, Project).
• Proactive and efficient in a fast-paced, high change environment.
• Excellent interpersonal, written, and verbal communication skills.
• Outstanding organizational skills.
• Strong analytical, strategic thinking, and problem-solving skills.
• Ability to quickly learn new tools, systems, and processes to improve efficiency.

Benefits

Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment.

Competitive compensation, including base salary, performance bonus, and equity.

100% employer-paid benefits package.

Flexible PTO; also, two, one-week company-wide shutdowns each year.

A commitment to your professional development, with access to resources, mentorship, and growth opportunities.

Salary Range: $X to $X. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.

Additional information can be found at https://www.crescentbiopharma.com/careers/#benefits.