The RoleLakefront Biotherapeutics is seeking a Clinical Trial Associate (CTA) to support execution and oversight of multiple clinical studies. The CTA will work as a key member of the Clinical Study Management Team, partnering with cross-functional colleagues, CROs, and lab vendors. This role will focus on study start-up, sponsor access management, vendor data reconciliation and QC, TMF oversight, and study tracking to ensure high-quality deliverables. The CTA will maintain oversight tools and documentation and contribute to process improvements. The ideal candidate is detail-oriented, proactive, and able to work independently while supporting the team in driving study execution and vendor oversight.
What You'll Do- Support clinical studies in partnership with CROs and lab vendors.
- Review and reconcile vendor data listings; perform QC checks to ensure accuracy and compliance.
- Monitor CRO/lab deliverables (sample data, reports, data transfers) against timelines and quality standards.
- Maintain study trackers, sponsor access management, oversight logs, and key documents (regulatory files, site/vendor contacts, approvals).
- Ensure completeness and compliance of the Trial Master File (TMF) through ongoing QC review.
- Assist with regulatory document review (EDPs, ICFs, lab certifications, IRB/IEC submissions).
- Support study start-up, site/vendor onboarding, and supply management.
- Contribute to study materials (manuals, newsletters, training content).Drive process improvement initiatives and strengthen vendor oversight practices.
What You Bring- Bachelor's degree in life sciences, healthcare, or related field.
- 2+ years of experience as a CTA or in a similar role within a biotechnology, pharmaceutical, or CRO environment.
- Demonstrated experience supporting clinical study operations, including vendor oversight, data reconciliation, and QC review.
- Strong background in Trial Master File (TMF) maintenance and study documentation management.
- Proven ability to manage study progress/oversight tools.
- Excellent organizational, problem-solving, and communication skills with the ability to work effectively across cross-functional teams and with external partners.
- Skilled in Microsoft Office Suite (Excel, PowerPoint, Word) and comfortable with clinical trial tracking systems and tools. Highly detail-oriented, proactive, and able to manage multiple priorities independently.
What We OfferBase compensation for this position ranges from $110,000 - $130,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics' performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.
At Lakefront Biotherapeutics, we are committed to attracting individuals who bring strong expertise, integrity, and a collaborative mindset. We value people who take ownership, work effectively across teams, and want to contribute to meaningful progress.
You will join a highly motivated and supportive team working together to advance our pipeline and strengthen how we operate. As we continue to build and grow, we offer an environment where individuals can develop, take on responsibility, and make a tangible impact.
