Clinical Research Manager- HYBRID

$81,900 - $150,500/Yr

University of California - Orange, CA

Full-time - Mid Level

Orange, CA

10,001+ employees

Educational Services

About the position

The Clinical Research Manager (CRM) at UC Irvine's Chao Family Comprehensive Cancer Center (CFCCC) plays a pivotal role in overseeing clinical research operations within a multidisciplinary environment. Reporting directly to the Assistant Director for the Clinical Trials Unit, the CRM is responsible for managing a diverse team of Clinical Research Coordinators (CRCs) and ensuring the successful execution of a large portfolio of complex oncology clinical studies. This position requires a deep understanding of clinical trial management, regulatory compliance, and effective communication with various stakeholders, including sponsors, governing agencies, and internal teams. The CRM serves as a key liaison, facilitating communication between the CFCCC and external partners such as the National Cancer Institute and pharmaceutical companies. This role involves attending Disease Oriented Teams (DOTs) meetings, ensuring adherence to clinical protocols, and managing the distribution of research workload among team members. The CRM is also tasked with overseeing the training and development of CRCs, conducting pre-study site selection visits, and implementing quality assurance measures to enhance research outcomes. In addition to operational management, the CRM is responsible for achieving the team's operational goals and objectives, which includes performance management, leave management, and other HR-related functions. The CRM must demonstrate strong leadership skills, the ability to motivate and mentor staff, and a commitment to fostering a positive and collaborative work environment. This position is essential for maintaining the integrity and success of clinical trials at UC Irvine, contributing to advancements in cancer research and patient care.

Responsibilities

• Manage the day-to-day operations of the Clinical Trials Unit, overseeing a team of Clinical Research Coordinators (CRCs) and Assistant Clinical Research Coordinators.
• Serve as the primary liaison to sponsors, governing agencies, and national cooperative oncology groups.
• Ensure adherence to clinical protocols and compliance with industry and federal sponsor data entry requirements.
• Supervise the distribution of clinical research workload among team members and manage staff performance.
• Lead ongoing training and education initiatives for CRCs and ensure their professional development.
• Conduct pre-study site selection visits and liaise with medical service units for trial conduct.
• Implement quality assurance and quality improvement goals through routine audits of the team's portfolio.
• Facilitate effective communication with external sponsors, colleagues, faculty, and staff to foster collaborative relationships.

Requirements

• Experience with clinical trial management systems, preferably OnCore.
• Extensive experience with clinical research and data collection methods.
• Demonstrated skills in employee supervision and HR administration.
• Experience in training others, particularly in the field of research.
• Working knowledge of clinical protocol design and content.
• Excellent interpersonal, organizational, and time management skills.
• Ability to cultivate relationships with multiple stakeholders at various levels of administration.
• Strong verbal and written communication skills, including technical writing capabilities.
• Ability to manage multiple priorities and work in a fast-paced environment.
• Demonstrated experience working within the guidelines of a national programmatic structure.

Nice-to-haves

• Clinical Trial Professional certification from a professional society within one year in position.
• Experience at a NCI-designated Comprehensive Cancer Center.
• Critical thinking skills to evaluate issues and identify potential solutions.
• Ability to maintain strict confidentiality and act with tact and diplomacy.

Benefits

• Medical insurance
• Sick and vacation time
• Retirement savings plans
• Access to discounts and perks