Our client is a clinical-stage biotechnology company advancing an innovative therapeutic program for patients with serious cardiovascular disease. As the organization continues to advance its clinical development activities, they are seeking an experienced and highly organized Clinical Project Assistant (CPA) to provide operational and administrative support to Clinical Operations and the broader clinical study team.
This individual will work closely with Clinical Operations leadership, Clinical Trial Managers, CROs, clinical sites, and external vendors to support the execution of a late-stage global clinical development program.
The Clinical Project Assistant will play an important role in keeping study activities organized and on track, maintaining high-quality clinical documentation, supporting the Trial Master File, coordinating study meetings and communications, and assisting with the day-to-day operational needs of the clinical program.
This is an excellent opportunity for someone who enjoys working within a lean, highly collaborative biotech environment where individuals are expected to take ownership, work across functions, and contribute beyond a narrowly defined role.
Key Responsibilities
Clinical Trial & Project Support
- Provide day-to-day operational and administrative support to Clinical Operations and assigned clinical study teams.
- Support clinical trial activities throughout study conduct, maintenance, and closeout.
- Partner closely with Clinical Trial Managers and Clinical Operations leadership to track study timelines, milestones, deliverables, risks, and action items.
- Maintain study trackers, dashboards, spreadsheets, databases, and other project-management tools.
- Coordinate internal and external study meetings, including scheduling, agendas, meeting materials, minutes, and follow-up of action items.
- Assist with the preparation and maintenance of study-specific documents, templates, presentations, and communications.
- Help coordinate activities across internal stakeholders, CROs, clinical sites, and external vendors.
- Proactively identify outstanding items and follow up with appropriate stakeholders to keep study activities moving forward.
TMF & Clinical Documentation
- Support the ongoing maintenance and quality of the Trial Master File (TMF/eTMF).
- Upload, file, organize, and maintain essential clinical trial documentation within appropriate systems and repositories.
- Perform routine quality-control reviews of clinical documentation for accuracy, completeness, and appropriate filing.
- Support ongoing TMF reconciliation and inspection-readiness activities.
- Work with CROs, vendors, and internal stakeholders to identify and resolve missing or incomplete documentation.
- Assist with document collection, tracking, archiving, and study closeout activities.
- Help ensure the TMF remains current and inspection-ready throughout the lifecycle of the study.
Clinical Systems & Study Tracking
- Maintain accurate and current study information within CTMS, eTMF, and other Clinical Operations systems.
- Assist with tracking site activity, enrollment, study milestones, vendor deliverables, and other key operational metrics.
- Maintain study dashboards and status reports to provide Clinical Operations leadership with visibility into study progress.
- Support data and document consistency across clinical systems, trackers, and repositories.
CRO & Vendor Support
- Assist Clinical Operations with the day-to-day coordination and oversight of CROs and study vendors.
- Track vendor deliverables, documentation, timelines, and outstanding action items.
- Support meeting coordination and communication between internal teams and external partners.
- Assist with purchase orders, invoices, study budgets, and financial tracking as needed.
- Help ensure vendor activities and documentation remain aligned with study timelines and expectations.
Compliance & Inspection Readiness
- Perform responsibilities in accordance with company SOPs, ICH/GCP, applicable regulatory requirements, and internal policies.
- Support ongoing audit and regulatory inspection-readiness activities.
- Assist Clinical Operations leadership with documentation requests associated with audits, inspections, and quality reviews.
- Identify documentation gaps and work with appropriate stakeholders to resolve them in a timely manner.
Cross-Functional Support
- Collaborate with Clinical Operations, Clinical Development, Data Management, Biometrics, Regulatory Affairs, Drug Safety/Pharmacovigilance, Quality, and other functions as needed.
- Support Clinical Operations process improvements, templates, tools, and workflows.
- Assist with additional clinical development projects based on program and organizational priorities.
- Be willing to take on responsibilities outside of the traditional CPA scope when needed within a lean clinical-stage organization.
Qualifications
- Bachelor's degree in Life Sciences, Healthcare, or a related discipline preferred.
- 1–3+ years of experience supporting clinical trials within a biotechnology, pharmaceutical, CRO, or investigative-site environment.
- Previous experience as a Clinical Project Assistant, Clinical Trial Assistant, Clinical Research Coordinator, Study Coordinator, or similar clinical research role.
- Experience supporting Phase II or Phase III clinical trials preferred.
- Experience supporting global or multi-site clinical studies is highly desirable.
- Understanding of clinical trial processes and the clinical study lifecycle.
- Working knowledge of ICH/GCP and applicable clinical research regulations.
- Hands-on experience with TMF/eTMF systems strongly preferred.
- Experience with CTMS and other Clinical Operations systems preferred.
- Previous experience working with CROs and external clinical vendors is desirable.
- Experience supporting study budgets, invoices, purchase orders, or vendor administration is a plus.
- Strong proficiency with Microsoft Office, including Excel, Word, PowerPoint, Outlook, and Teams.
Key Competencies
- Exceptional organizational skills and attention to detail.
- Strong sense of ownership and accountability.
- Ability to manage multiple priorities, stakeholders, and deadlines simultaneously.
- Proactive approach to identifying outstanding items and driving them toward resolution.
- Strong written and verbal communication skills.
- Comfortable working independently in a remote environment.
- Ability to operate effectively within a small, fast-moving biotechnology company.
- Comfortable working with senior clinical leadership as well as CROs, vendors, and investigative sites.
- Strong commitment to documentation quality, GCP compliance, and inspection readiness.
- Flexible and willing to contribute wherever needed to support the success of the clinical program.
Ideal Candidate
The ideal candidate is a highly organized and proactive Clinical Operations professional who thrives in a lean biotech environment and enjoys being at the center of study execution.
This person will be comfortable supporting a complex, late-stage clinical program while keeping study documentation, meetings, trackers, vendors, systems, and action items organized and moving forward.
They will bring a strong attention to detail, a willingness to take ownership, and the ability to anticipate what the Clinical Operations team needs before being asked.
Cardiovascular clinical trial experience is highly desirable but not required.