Clinical Research Site Manager

Knowledge Research Center•Orange, CA

About The Position

The Clinical Site Manager will assume a leadership role in overseeing all clinical research activities at the designated site, including industry-sponsored studies and investigator-initiated studies. This individual will manage multiple study managers, clinical research coordinators (CRC), research assistants, Nurse Practitioners (NPs), and Physician Assistants (PAs), ensuring the smooth execution of study protocols and operational activities. Additionally, the Clinical Site Manager will drive growth initiatives, develop a comprehensive marketing plan, oversee budget management, and monitor personnel performance and hours.

Requirements

5 years of relevant experience
3 years of work experience with Good Clinical Practice (GCP)
3 years of work experience with Clinical Practices
2 years of work experience with Clinical Trials
Willing to undergo a background check, in accordance with local law/regulations
Legally authorized to work in the United States
Willing to take a drug test, in accordance with local law/regulations

Responsibilities

Manage and coordinate all aspects of clinical studies conducted at the site.
Ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
Work with study managers, CRCs, research assistants, NPs, and PAs to allocate resources effectively and divide study responsibilities among staff members.
Provide leadership and guidance to study managers, CRCs, research assistants, NPs, and PAs.
Foster a collaborative and supportive work environment.
Conduct regular meetings and performance evaluations.
Develop and implement operational strategies to streamline processes and optimize efficiency.
Monitor key performance indicators (KPIs) to track study progress and identify areas for improvement.
Develop and execute a marketing plan to increase awareness of clinical research opportunities and attract participants and studies.
Collaborate with internal and external stakeholders to implement targeted outreach efforts.
Set growth targets and develop strategies to achieve them.
Monitoring studies start up
Exploring new studies especially those related to phase I, obesity, vaccine and Alzheimer’s studies.
Oversee the budget for personnel, ensuring proper allocation of resources.
Balance the budget and expenses to optimize financial resources.
Monitor expenses and identify opportunities for cost savings or efficiencies.
Monitor the performance and hours of Nurse Practitioners (NPs) and Physician Assistants (PAs) and research team involved in clinical research activities.
Ensure compliance with work hour regulations and performance expectations.
Provide feedback and support to optimize productivity and quality of work.