Clinical Trial Associate

Generate Biomedicines; Somerville (MA); On-site; USD 79,000 - 103,000; Full time

Job summary

Generate Biomedicines is seeking a detail-oriented Clinical Trial Associate to support the Clinical Development team in conducting Phase 1-3 trials and ensuring high-quality execution for regulatory submissions.

The role requires collaboration with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection readiness, study documentation, and adherence to GCP standards. A 6–12 month trial support background and a life sciences degree are preferred.

Qualifications

• Bachelor’s degree in life sciences or related field preferred.
• 6 months to 1 year of experience supporting Phase 1-3 trials at sponsor/CRO.
• Familiarity with FDA and ICH-GCP requirements for pivotal studies.
• Strong organizational, problem solving, and communication skills.
• Understanding of clinical drug development processes and study/site management.
• Proficient with MS Office (Word, Excel, PowerPoint).
• Knowledge of data quality and protocol deviation reporting.

Responsibilities

• Support Phase 1-3 trial execution, including site activation and study conduct.
• Manage TMF setup, maintenance, and QC for inspection readiness.
• Review monitoring reports, deviations, and KPIs with CROs.
• Coordinate with internal teams to align trials with regulatory requirements.
• Collect and review regulatory documents for trial initiation and maintenance.
• Organize study meetings and logging of actions/decisions.
• Track timelines, identify risks, and support mitigation planning.
• Assist in audit readiness and regulatory filing preparation.

Skills

Organizational skills

Communication

Problem solving

Attention to detail

Time management

Education

Bachelor’s degree in life sciences

Tools

eTMF

CTMS

MS Office

Job description

The Role:

Generate:Biomedicines is seeking a detail-oriented and highly collaborative Clinical Trial Associate to support clinical trials within our Clinical Development team. Reporting into Clinical Operations, this role will play a critical part in enabling high-quality execution of pivotal trials designed to support regulatory submissions and eventual product approval. The CTA will work cross-functionally with Clinical Supply, Data Management, Regulatory, QA, and CROs to maintain inspection-readiness, ensure compliance with GCP standards, and support key trial deliverables.

This is an exciting opportunity for someone who thrives in high-accountability environments and is eager to contribute to the final stages of clinical development with rigor and excellence.

Here’s how you will contribute:

• Support execution of Phase 1-3 clinical trials, including global site activation, study conduct, and closeout activities.
• Manage Trial Master File (TMF) setup, maintenance, and QC to ensure real-time, inspection- ready documentation.
• Collaborate with CROs to review monitoring visit reports, protocol deviations, and key performance indicators (KPIs).
• Coordinate with internal teams and vendors to ensure trial activities align with the stringent regulatory requirements of Phase 1-3 trials.
• Assist in the collection and review of essential regulatory documentation required for trial initiation and maintenance.
• Organize study meetings, manage action and decision logs, and ensure high-quality documentation of operational progress.
• Track progress against timelines, elevate risks or delays, and contribute to mitigation planning.
• Support clinical audit readiness efforts, including document review, reconciliation, and regulatory filing preparation.
• Maintain informed consent and protocol amendment tracking across global trial sites.
• Assist in clinical vendor invoice reconciliation and budget tracking.

The Ideal Candidate will have:

• Bachelor’s degree; life sciences or related degree preferred
• 6 months to 1 year of experience supporting Phase 1-3 clinical trials at a sponsor or CRO.
• Proficient in clinical systems (eTMF, CTMS) and knowledgeable of FDA and ICH-GCP requirements for pivotal studies.
• Demonstrates strong organizational skills, problem solving, and effective communication
• Demonstrates understanding of the clinical drug development process, including study design, protocol objectives and operational impacts
• Ideal candidates will have understanding site management and monitoring practices, including importance of data quality/integrity, as well as fundamental understanding of protocol deviation identification and reporting
• Must be proficient in MS Office applications (word, excel, and PowerPoint at a minimum) to support study/program documentation and deliverables
• Basic understanding and importance of current ICH-GCP regulations/guidelines is required
• Enthusiastic, proactive, collaborative, and dependable
• Excited to learn and grow within the clinical operations team!
• Organized (with attention to detail) and able to problem solve
• Comfortable in a fast-paced environment and able to manage and prioritize competing tasks

A preferred candidate has been identified for this role but all applicants will be considered.

About Generate Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Compensation:

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.
Per Year Salary Range
$79,000—$103,000 USD