Your Role on the TeamUnder the supervision of the Clinical Research Supervisor and Chief Administrative Officer, the Project Manager will apply project management and research administration expertise to oversee complex grant activities from concept through execution. The Project Manager independently manages multiple projects, provides strategic guidance to investigators, and leads initiatives to improve investigator iniated research processes and policies. The incumbent will also assist the research unit in creating and conducting investigator and staff training programs. The incumbent will assist with the mentoring and training of the unit's clinical research coordinators and project support staff.
This position requires strong judgment, initiative, and the ability to navigate evolving regulatory and operational requirements in clinical research.
This position requires the ability to work independently as well as creating and maintaining interprofessional relationships with deparments within UCI. The incumbent will have strong interpersonal skills to communicate with PIs, Co-Is, SPA, finance, regulatory bodies, and other institutions.
What It Takes to be SuccessfulRequired:- Ability to establish and maintain effective working relationships across the Health System
- Ability to maintain a work pace appropriate to the workload and adapt to a rapidly changing work environment
- Must demonstrate customer service skills appropriate to the job; ability to interact with patients and caregivers in a compassionate and empathetic manner
- Excellent written and verbal communication skills in English
- Must possess the skill, knowledge and ability essential to the successful performance of assigned duties
- Proven ability to research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence; ability to think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way
- Proven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team
- Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly; proactive problem-solving abilities and follow through
- Proven ability to independently exercise discretion and sound judgment
- High level of integrity and honesty in maintaining confidentiality
- Proven ability to maintain flexibility and adaptability; demonstrate teamwork, cooperation, self-control, and flexibility to get the work done
- Proven ability to establish and maintain files and records
- Working knowledge of computer software including Microsoft Office (Word, Excel, and Adobe Acrobat)
- Proven ability to establish and maintain cooperative and collegial working relationships; demonstrated skill in interacting with the public, faculty and staff of various social, cultural, economic and educational backgrounds
- Ability to read and understand clinical trial protocols
- Understanding of FDA regulations, GCP/ICH guidelines, and applicable clinical trial regulations
- Working knowledge of current protocols and internal SOPs
- Familiarity with medical terminology and medical/clinical environment
- Demonstrated strong data management skills and attention to detail.
- Demonstrated ability to provide excellent customer service experience for patients; responding to patient needs in a timely manner.
- Demonstrated ability to interacts with patients and caregivers in a compassionate and empathetic manner.
- Demonstrated track record of human subjects research (Registry, Observational, Phase I, II, III drug trials, and device trials) coordination
- Strong knowledge of clinical research processes, regulatory requirements, and study start-up activities
- Excellent communication and interpersonal skills
- Experience developing SOPs, policies, or training programs
- Familiarity with academic medical center environments and translational research
- Experience supporting multi-site or collaborative research initiatives
- Bachelor's degree in related area or equivalent combination of education and/or equivalent experience
- Certification in Clinical Research
- 5 or more years of related work experience as a clinical research coordinator (CRC)
- 3-5 years of experience with project management
Preferred:- Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored); knowledge of clinical trial federal, state and local regulation requirements
- Professional certification through SOCRA or ACRP
Special Conditions:- May require some flexibility to work evenings or weekends as needed to support project deadlines
- May require travel to off-site research locations
Total RewardsIn 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.