Clinical Research Manager - 59645-1A

Updated: Dec 8, 2023
Location: Orange-Campus
Job Type:
Department: UCI Ctr for Clinical Research

Position Summary:

The UCI Center for Clinical Research is driven to improve the health and wellness of people in Orange County and the world by providing life-saving clinical trials designed to strengthen and accelerate the pathway of discovery from the medical laboratory to the clinic. Built as an excellent clinical research program designed to serve our patients, community, investigators and partners with a high level of efficiency, integrity and quality. With hundreds of clinicians and researchers dedicated to innovating, accelerating, growing and inspiring new ways to address and treat disease. Their expertise gives us an edge in treatments and trials related to a full spectrum of conditions. Our devoted team of nationally regarded physicians and nurses, researchers and clinicians, educators and students are all united by a single calling – to improve the lives of the people in our community and beyond. We are unique in our ability to provide the most compassionate healthcare and research because we are driven by our passion for innovation, grounded in the best medical and scientific knowledge available.

Incumbent is responsible for leading on-going training and education of CRCs, leading and managing pre-study site selection visits (PSSVs) including liaising with all appropriate medical service units (e.g., Investigational Drug Service, Pathology, Radiology, etc.) for the conduct of the trial, managing quality assurance and quality improvement goals and objectives through routine audit reviews of the team’s portfolio.

Total Compensation:

In addition to the salary range listed below, we offer a wealth of benefits to make working at UCI even more rewarding. These benefits may include medical insurance, sick and vacation time, retirement savings plans, and access to a number of discounts and perks. Please utilize the links listed here to learn more about our compensation practices and benefits.

$81,900.00 - $116,200.00 (Annual Salary) Expected Pay Range within the Full Salary Range $81,900.00 - $150,500.00 (Annual Salary)

Required:

5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment. Bachelor's degree in related area. Advanced degree and SoCRA/ACRP certification preferred. Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters. Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities. Demonstrated skills in employee supervision and HR administration. Demonstrated experience in training others, particularly in the field of research. Critical thinking skills to evaluate issues and identify a potential solution. Clear and concise communicator; good verbal and written communication Skills. Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Interpersonal skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration. Effective oral and written communication skills with technical writing skills sufficient to compose a variety of scientific documents, reports, budgets and justifications which are clear, concise, logical and display syntax and grammar. Working knowledge of clinical protocol design, content and categories for inclusion in a final document. Ability to maintain strict confidentiality and to act and interact on sensitive issues with tact and diplomacy. Ability to establish and maintain cooperative working relationships with external sponsors, colleagues, faculty and staff. Excellent interpersonal, organizational and time management skills. Ability to work both independently and as part of team. Ability to take initiative and demonstrate strong commitment to duties. Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction. Ability to accept equivocal circumstances and take action where answers to a problem are not readily apparent. Ability to analyze complex problems involving long-range planning including sources for information and data, and summarizing information into a logical format for presentation. Organizational skills to establish effective workload priorities to facilitate multiple programmatic functions such as clinical, research, and administrative. Skill in performing a variety of duties, often changing from one to another with frequent interruptions. Skill in composing letters, preparing documents, and facilitating the production of materials. Extensive experience with clinical research and data collection methods. Ability to work within a deadline-driven structure. Experience in maintaining flexibility and adaptability while supervising and implementing institutional change. Willingness to work as a supportive, cooperative member of an interdisciplinary team. Foster and promote a positive attitude and professional appearance. Expertise with Microsoft Office (Word, Excel, Outlook, Powerpoint). Access to transportation to off-site research locations. Travel to Irvine campus and satellite work sites as needed.

Bachelor's degree in related area.

Clinical Trial Professional certification from a professional society within one year in position.

Distributes work. Monitors the progress of work of assigned staff. Researches and resolves issues and discrepancies. Manages subordinates' quality and quantity of work to ensure unit meets its objectives. Reports performance evaluation to management. Follows internal policies and processes. Supervises assigned staff to ensure compliance. Trains employees on research regulatory processes, database entry, and working with participant families. Implements and maintains defined research study processes. Serves as a liaison between staff and program leaders. Reports work effort to the department. Cultivates communication and teamwork between cross-functional teams working on research. Initiates a clinical trial study. Oversees and reviews study and helps create systems and forms to ensure research billing, packets for recruitment and calendars are developed. Reviews accrual and eligibility for each patient placed on a clinical trial to ensure human subject protection regulations are in compliance and quality recruitment. Multi-tasks and prioritizes to smoothly coordinate studies and ensure patient safety. Supervises the timeliness and quality of data collection, submission and completion. This includes training new study coordinators in collecting and understanding source documentation, creating forms for ensuring proper reporting of adverse events and protocol adherence to federal regulations. Monitors and audits visits. Monitors preparation in order to oversee and assist study coordinators in preparing for audits. Ensures data is sufficient and updated, including all regulatory documentation. Uses computer applications to generate reports and quality assurance of required data entry. Attends all meetings with auditors. Assists staff assigned with monitoring site compliance. Tracks patient charges and alerts the department on billable triggers to collect money. Understands budget preparation for clinical trials; interprets and trains the study coordinators on how to proceed in proper data research billing. Coordinates with billing to resolve disputed charges. Oversees the incoming data interpreted from samples and ensures that it is correctly entered into respective databases, and reviewed. Ensures integrity and security of samples. Recommends salary actions, promotions, and terminations. Recommends personnel-related actions. Participates in the recruitment and orientation of new employees. Evaluates assigned staff performance and reports to management. Provides guidance and excellent judgement. Seen as a role model by assigned staff.

Preferred:

Advanced degree preferred.