Clinical Research Manager - 17147-1A

Updated: Jun 29, 2022
Location: Irvine-Campus
Job Type:
Department: UCI Ctr for Clinical Research

Job Opening ID: 17147

Reports To: Director of Clinical Research Operations

Working Title: Clinical Research Manager

Department: UCI Ctr for Clinical Research

Bargaining Unit: 99

FLSA: Exempt

Payroll Job Code: 009548

Job Location: UCI Campus- Irvine

Percent of Time: 100%

Work Schedule: 8-5, M-F

Employee Class: Career

 

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.

 

Under the general direction of the Director of Clinical Research Operations in the School of Medicine – Center for Clinical Research (CCR), The Clinical Research Manager (CRM) is responsible for all clinical research activities for assigned portfolios for the different school of medicine departments. This includes managing site evaluation and site activation, working as a point of contact for start-up activities, clinical trials management, and supervising, administering, and achieving operational goals and objectives for implementation within his/her assigned portfolios. The CRM is directly responsible for working with faculty and all elements of a multi-level research network and different departments at UCI health.

The CRM will serve as the point of contact with sponsors, governing agencies, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The CRM supervises the day-to-day management of a team of Clinical Research Coordinators (CRCs), and Assistant Clinical Research Coordinators overseeing and coordinating a large portfolio of clinical studies. The incumbent is responsible for training clinical research team members, evaluating their performance, and leading staff learning and development, leave management and schedules, and all other HR-related functions

The CRM is directly responsible for creating and implementing study-specific clinical monitoring tools and documents to ensure his/her team’s compliance with protocols, SOPs, local regulations, and CFR, ICH, and GCP guidelines.

The CRM is expected to work with the Center for Clinical Research (CCR) leadership team to set up plans for expanding clinical trial portfolios and increasing research subjects’ enrollments into clinical trials. The CRM is responsible for identifying trials with difficulties enrolling new research subjects and discuss plans with the CCR leadership team to overcome these challenges.

 

Compensation Range:

 

Annually: $66,300 - $112,200

 

Department Website:

 

https://clinicalresearch.som.uci.edu

 

Required:

 

  • Bachelor's degree in related area. Advanced degree and SoCRA/ACRP certification preferred.
  • 5 - 7 years of experience with BA/BS or equivalent years of relevant experience in an academic and/or research environment. 
  • Clinical Trial Professional certification from a professional society within one year in position.
  • 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.
  • 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.
  • 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.
  • 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 effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment.
  • Adaptable to quickly changing priorities.
  • 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.
  • Working knowledge of clinical protocol design, content, and categories for inclusion in a final document.
  • Demonstrated experience working within the guidelines of a national programmatic structure with strict policies and parameters.
  • Clear and concise communicator; good verbal and written communication skills.
  • 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.
  • 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.
  • Ability to act independently with demonstrated problem-solving skills, multi-task and to follow through on assignments with minimal direction.
  • 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.
  • 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.

 

Final candidate subject to background check. As a federal contractor, UC Irvine is required to use E-Verify to confirm the work status of individuals assigned to perform substantial work under certain federal contracts/subcontracts.

 

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

 

UCI provides reasonable accommodations for applicants with disabilities upon request. For more information, please contact Human Resources at (949) 824-0500.

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