Clinical Trial Associate in Waltham, Massachusetts at Crescent Biopharma
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Crescent Biopharma
Waltham, Massachusetts, 02451, United States
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Job Description
Clinical Trial Associate
Responsibilities
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.
We are seeking a Clinical Trial Associate (CTA) will work with the Clinical Study Lead and Director of Clinical Operations to support the conduct of clinical trials. The CTA will partner with the Clinical Study Lead to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines.
CTA may independently manage components of clinical studies, including but not limited to vendor oversight, budgets, responsibility for a subset of sites or countries, or phases of the trial (startup period, for example), with oversight.
- 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.
- 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
- 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
The salary range for this position is $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 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
Please note:
Crescent Biopharma is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.
Please note, Crescent does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Crescent and the agency. Crescent will not pay any fees related to unsolicited resumes.
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Job Location
Waltham, Massachusetts, 02451, United States
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