Jen HayesJH
Open to opportunities

Jen Hayes

@jenhayes

Results-driven Clinical Research Associate with over 5 years experience.

United States
Message

What I'm looking for

I am looking for a role that fosters collaboration, innovation, and continuous learning, where I can contribute to impactful clinical research projects and grow professionally.

I am a results-driven Clinical Research Associate (CRA) with over 5 years of experience in delivering impactful solutions in fast-paced clinical research environments, including IVD and medical device trials. My proven track record of leveraging data, technology, and strategic thinking has enabled me to solve complex problems, streamline operations, and drive business value. I thrive in dynamic settings where adaptability, initiative, and efficiency are key to success.

In my current role as a Senior Clinical Research Associate at CareSource, I lead monitoring activities across multiple Phase II and III clinical trials, ensuring compliance with GCP and ICH guidelines. I have successfully conducted over 50 remote and on-site monitoring visits while maintaining 100% compliance with monitoring timelines. My commitment to continuous improvement is reflected in my collaboration with cross-functional teams to enhance project productivity and efficiency.

Throughout my career, I have trained and mentored junior CRAs, boosting team productivity and ensuring adherence to clinical and regulatory standards. My expertise spans various therapeutic areas, including oncology and neurology, and I am dedicated to maintaining the highest quality outcomes aligned with organizational goals.

Experience

Work history, roles, and key accomplishments

CA
Current

Senior Clinical Research Associate

CareSource

May 2023 - Present (2 years 2 months)

Led monitoring activities across 8+ Phase II and III clinical trials, including IVD and medical device studies, ensuring compliance with GCP, ICH guidelines, and CareSource SOPs. Conducted over 50 remote and on-site monitoring visits, maintaining 100% compliance with monitoring timelines.

HB

Senior Clinical Research Associate

Henlius Biotech

Jul 2021 - Mar 2023 (1 year 8 months)

Partnered with Clinical Trials Manager to lead global studies from start-up through database lock, ensuring milestones and deliverables were achieved within timelines. Provided hands-on support to a team of 6 CRAs, offering guidance on site issues, protocol clarifications, workload balancing, and vendor coordination.

HS

Clinical Research Coordinator / CRA

Henry Schein

Jan 2020 - Jun 2021 (1 year 5 months)

Coordinated 8+ clinical studies from initiation to close-out, including studies involving medical devices and IVD diagnostics, supporting Investigators and Study Managers in ensuring protocol compliance and data quality. Scheduled and managed over 100 patient visits, maintained subject tracking logs, and ensured timely completion of case report forms (CRFs).

Education

Degrees, certifications, and relevant coursework

NS

Not specified

MSc, Public Health

Focused on advanced public health principles and research methodologies. Developed expertise in data analysis and public health interventions.

NS

Not specified

BSc, Microbiology

Studied the fundamentals of microbiology, including microbial genetics, immunology, and virology. Gained practical laboratory experience in microbial culture and analysis.

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Jen Hayes - Senior Clinical Research Associate - CareSource | Himalayas