Clinical Trial Associate/Senior Clinical Trial Associate

Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific antibody, as well as novel antibody-drug conjugates. By leveraging multiple modalities and established targets, Crescent aims to rapidly advance potentially transformative therapies as single agents and as part of combination regimens to treat a range of solid tumors. For more information, visit www.crescentbiopharma.com and follow the Company on LinkedIn and X.

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.

Education & Experience

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
Must have excellent interpersonal, written and verbal communication skills
Ability to interact well with various team members and provide value added support to project
Outstanding organization skills
Strong analytical, strategic thinking, and problem-solving skills.
Ability to quickly learn new tools, systems, and processes to improve efficiency

What We Offer

• 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
• Two, one-week company-wide shutdowns each year
• A commitment to your professional development, with access to resources, mentorship, and growth opportunities

Salary Range

The anticipated salary range for this position is $108,000 to $132,000. 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 Description for Pay Transparency:
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. Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave. Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits