Project Manager-Supervisor

University of California, Irvine•Orange, CA

1d•Onsite

About The Position

Under 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.

Requirements

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

Nice To Haves

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

Responsibilities

Oversee complex grant activities from concept through execution.
Independently manage multiple projects.
Provide strategic guidance to investigators.
Lead initiatives to improve investigator initiated research processes and policies.
Assist the research unit in creating and conducting investigator and staff training programs.
Assist with the mentoring and training of the unit’s clinical research coordinators and project support staff.
Establish and maintain effective working relationships across the Health System.
Maintain a work pace appropriate to the workload and adapt to a rapidly changing work environment.
Demonstrate customer service skills appropriate to the job; interact with patients and caregivers in a compassionate and empathetic manner.
Research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence.
Think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way.
Manage 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.
Work independently, take initiative and follow through on assignments.
Analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
Exercise discretion and sound judgment.
Maintain confidentiality.
Maintain flexibility and adaptability; demonstrate teamwork, cooperation, self-control, and flexibility to get the work done.
Establish and maintain files and records.
Establish and maintain cooperative and collegial working relationships.
Interact with the public, faculty and staff of various social, cultural, economic and educational backgrounds.
Read and understand clinical trial protocols.
Manage data effectively with attention to detail.
Provide excellent customer service experience for patients; responding to patient needs in a timely manner.
Coordinate human subjects research (Registry, Observational, Phase I, II, III drug trials, and device trials).
Support multi-site or collaborative research initiatives.