Clinical Trial Associate

About Crescent Biopharma

Crescent Biopharma is committed to becoming a top oncology company by developing innovative cancer therapies. Their clinical-stage pipeline includes a PD-1 x VEGF bispecific antibody and novel antibody-drug conjugates. By integrating multiple therapeutic approaches, the company aims to rapidly deliver transformative treatments for various solid tumors, both as monotherapies and combination regimens.

Role Overview

The Clinical Trial Associate (CTA) will collaborate closely with the Clinical Study Lead and Director of Clinical Operations to ensure successful clinical trial execution. The CTA will help manage clinical studies, focus on timelines, budgets, compliance with SOPs, FDA regulations, and ICH/GCP guidelines. With some oversight, CTAs may independently handle certain trial components such as vendor supervision, budgets, or managing specific sites, countries, or trial phases.

Key Responsibilities

• Assist the Clinical Study Lead and Clinical Operations team in daily clinical trial operational tasks to meet objectives, timelines, quality standards, and regulatory requirements.
• Oversee CROs, vendors, and investigator sites by reviewing monitoring visit reports, maintaining communications, and resolving study-related issues.
• Maintain and update study tracking tools for documentation and operational activities including site activation, enrollment, monitoring status, IRB/EC approvals, safety communications, training compliance, and milestones.
• Support the Trial Master File (eTMF) management through document collection, filing, reconciliation, quality control, and preparation for audits.
• Assist with preparation of meeting agendas, minutes, action logs, and study status reports ensuring smooth communication among internal teams, CROs, vendors, and sites.
• Collaborate with Regulatory Affairs, Clinical Supplies, Data Management, Safety, Quality, and other teams to meet study deliverables and timelines.
• Manage training records for study teams ensuring compliance with SOPs, regulations, and company policies.
• Process system access requests for study team and site staff as required.
• Identify, communicate, and escalate any study risks, protocol deviations, and operational challenges as appropriate.

Required Qualifications and Experience

• Bachelor’s degree in scientific or related field plus a minimum of 2 years’ experience in Clinical Operations, clinical research, healthcare, or equivalent background.
• Strong familiarity with FDA regulatory requirements and ICH/GCP guidelines.
• Experience working effectively with CROs and vendors.
• Proficient with Microsoft Word, Excel, PowerPoint, and Project.
• Ability to work proactively in dynamic, fast-changing environments.
• Excellent interpersonal, written, and verbal communication skills.
• Ability to collaborate well with team members and contribute meaningful project support.
• Highly organized with strong analytical, strategic thinking, and problem-solving abilities.
• Quick to learn new tools, systems, and processes to enhance efficiency.

Benefits and Perks

• Join a mission-driven team contributing impactful cancer research with opportunities for varied responsibilities and rapid growth.
• Competitive salary package including base pay, performance-related bonuses, and equity incentives.
• Comprehensive employer-funded benefits coverage.
• Flexible paid time off plus two annual company-wide one-week shutdowns.
• Support for professional development through access to resources, mentorship, and career growth opportunities.

Compensation and Additional Information

The salary range for this position is competitive and depends on factors such as experience, education, and geographic location. Employees and eligible dependents may participate in company-sponsored benefits such as medical, dental, vision, life insurance, and disability coverage. There is also participation in the company's savings plan (401(k)) and long-term incentive programs. Time off benefits include unlimited PTO, 10 sick days yearly, holiday pay with company shutdowns, parental leave, FMLA, and military leave. Further benefits detail is available on the company website.

Equal Opportunity Employer Statement

Crescent Biopharma is dedicated to maintaining an inclusive and equitable workplace free from discrimination based on race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or other protected categories. Employment decisions are based solely on merit and business needs.

Agency Notice

Please note that Crescent Biopharma does not accept unsolicited resumes from external recruiters or agencies and is not liable for fees related to unsolicited submissions.