Clinical Trial Associate

Lakefront Biotherapeutics; San Francisco (CA); On-site; USD 110,000 - 130,000; Full time

Job summary

Lakefront Biotherapeutics is seeking a Clinical Trial Associate to support execution of multiple clinical studies and partner across cross-functional teams. The CTA will focus on study start-up, sponsor access management, vendor data reconciliation, QC, and TMF oversight, ensuring high-quality deliverables.

The ideal candidate has 2+ years of CTA experience, TMF and regulatory docs expertise, and strong communication skills to collaborate with CROs, labs, and external partners.

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field.
• 2+ years of CTA experience in biotech/pharma/CRO environments.
• Experience supporting clinical study operations, including vendor oversight, data reconciliation, and QC.
• Strong TMF maintenance and study documentation management.
• Proven ability to manage study progress/oversight tools.
• Excellent organizational, problem-solving, and communication skills across cross-functional teams and external partners.
• Proficient with Microsoft Office Suite and trial tracking systems.

Responsibilities

• Support clinical studies in partnership with CROs and lab vendors.
• Review and reconcile vendor data listings; perform QC checks for accuracy and compliance.
• Monitor CRO/lab deliverables against timelines and quality standards.
• Maintain study trackers, sponsor access management, oversight logs, and regulatory files ( TMF, site/vendor contacts, approvals ).
• Ensure completeness and compliance of the 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 and drive process improvement; strengthen vendor oversight.

Skills

CTA experience

Vendor oversight

Data reconciliation

TMF maintenance

Regulatory document review

Communication

Education

Bachelor’s degree in life sciences, healthcare, or related field

Tools

Microsoft Office Suite

Clinical trial tracking systems

Job description

About Lakefront Biotherapeutics

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.

About Lakefront Biotherapeutics

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.
Our lead asset is being developed for severe immune‑mediated diseases, while additional preclinical programs expand the long‑term potential of our R&D pipeline. At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities.
Are you ready to transform lives and be part of a journey like no other? We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, we operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully.
We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.
If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

The Role

Lakefront 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 Offer

Base 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.

Lakefront Biotherapeutics is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.