Business development
We work to open new avenues for UCI researchers to conduct clinical research studies. The Business Development teams actively forge new relationships with leading clients such as pharmaceutical companies, medical device manufacturers and contract research organizations (CROs). We work to understand their clinical research services at UCI and form strategic partnerships that help you successfully execute your clinical research studies.
If you seek to delve into a particular research field but need to choose a study to conduct, please schedule a meeting by emailing our Business Development team or filling out the form below.
Clinical Research Coordinator (CRC)
Toward the end of the activation process, your assigned CRM will designate a CRC to your study.
Our operations team includes experienced CRCs, healthcare professionals responsible for managing the day-to-day operations of clinical research studies. The team works closely with PIs and other research team members to conduct study activities according to the protocol, regulatory requirements and ethical principles.
CRC duties include:
- Recruiting and screening study participants
- Obtaining informed consent
- Collecting and managing data
- Coordinating study visits and procedures
- Monitoring participants for adverse events
IRB Submission
- The UCI IRB is required to review and approve all research involving human subjects. No human research may begin until an UCI IRB exempt confirmation or UCI IRB approval letter is provided.
- The UCI-CCR Regulatory Team will help submit your study to the IRB.
Research nursing
The Nursing & Laboratory Services team includes registered nurses (RNs), medical assistants (MAs) and laboratory specialists with training in clinical research. They provide a wide range of services at UCI Medical Center and on-campus clinic locations, including:
Center for Innovative Health Therapies
The Center for Innovative Health Therapies (CIHT) is in the City of Orange in the middle of UCI Medical Center across from the main hospital and next to the outpatient imaging center. The custom-designed, self-contained, 5,000-square-foot clinical research space includes:
- A waiting and reception area
- Six nursing stations
- Three consultation/interview rooms
- Two examination/procedures rooms
- Six treatment/infusion rooms
- A two-station phlebotomy area
- Two medical preparation/clean rooms
- Laboratory
- Processing room
The facility also has continuously temperature-monitored refrigeration, which includes -20 degrees Celsius freezers, a large -80 degrees Celsius freezer and liquid nitrogen storage. All areas integrate into the Epic electronic medical record (EMR) system to review and retrieve all patient information directly such as:
- Vital signs
- Height
- Weight
- Infusion pumps
- Electrocardiogram (ECG) readings
Hewitt Hall
Located on the UCI School of Medicine campus in Irvine, this dedicated clinical research space has four treatment/infusion rooms and three consultation rooms upgraded with a mobile Epic EMR system.
Recruitment team
At UCI Health, our seasoned clinical research experts empower you with the skills and knowledge needed for successful enrollment in UCI clinical research studies. From initial kick-off meetings to ongoing strategy revisions, we're committed to maximizing your study's success. We also offer additional recruitment meetings throughout enrollment to revisit or revise the enrollment plan.
Contact the CCR recruitment team
Training
Our clinical research experts are here to equip you with skills and knowledge to conduct clinical research at UCI and help you achieve your research objectives. Your designated Clinical Research Manager (CRM) will help coordinate with all relevant teams and organize necessary training to ensure your clinical trial's success. Below are some links to standard trainings for clinical research professionals:
- Collaborative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) Training
- CITI Training (Human Research Protections and Research and HIPAA Privacy Protections) is a required training course provided under the UCI Office of Research that all clinical research teams must complete in order to conduct or be involved in a clinical research study at UCI.
- Clinical Research 101 by UCI Research Compliance
- Introductory course intended for clinical research staff. Attendees will learn about the basic concepts of clinical research and navigating research at UCI.
- (2020) Privacy & Security Training: HIPAA - Healthcare Privacy Laws
- This course will introduce you to healthcare privacy compliance at University of California. You'll learn about the Health Insurance Portability and Accountability Act (HIPAA), Protected Health Information (PHI) and the procedures, requirements and safeguards that are necessary to keeping our patients' medical and other personal information private and protected.
- UC EPIC: Inpatient/Ambulatory View Only (Retrieval)
- This course can be taken by UCI researchers who would like read-only access to Epic EMR.
- Alpha Clinic Education and Training Programs
- Alpha Clinic Clinical Investigator Training Program
- Alpha Clinic Clinical Research Coordinator Training Program
- COMPASS Training Program
Support from other Research Units at UCI
Investigator FAQs
Any systematic investigation (including pilot studies, program evaluations and qualitative research), that aims to develop or contribute to generalizable (scholarly) knowledge and uses living humans or identifiable private information about living humans.
Before starting a clinical research study, sponsors and CROs require a CDA. According to UCI policy, Investigators can't sign CDAs; the Clinical Research Manager (CRM) handles this with UCI's legal teams.
A clinical research CDA is a legal contract between parties involved in clinical research, like sponsors, CROs and academic institutions. It protects confidential information shared during the study, such as protocols and results. CDAs safeguard intellectual property and study integrity.
Most sponsors and Clinical Research Organizations (CROs) require a site selection process, and our clinical research teams can assist with this process.
Clinical research site selection identifies and evaluates potential sites to successfully conduct clinical research studies. The process includes factors such as patient population, UCI capabilities and infrastructure, recruitment potential, and regulatory and logistical considerations.
Site selection is a critical aspect of clinical trial planning and helps identify sites that can:
- Successfully enroll and retain study participants
- Conduct study procedures according to the protocol
- Meet regulatory and ethical requirements
Site selection requires careful consideration and evaluation of multiple factors to ensure the study's success, as it is often dependent on the selected sites' performance.
Our teams can assist with the preparation and conduction of the SIV. For the SIV, the sponsor or contract research organization (CRO) ensures the study site is prepared to conduct the study in compliance with protocol, regulatory requirements and ethical principles.
During the SIV, the study team provides training on the study protocol, procedures and documentation. The team also reviews the study site's infrastructure, equipment and staffing. The SIV helps ensure the study is initiated correctly, the study team is properly trained and all study-related procedures are executed according to the protocol and regulatory requirements.
Contract negotiation occurs during the pre-award phase of a clinical trial. It involves negotiation of the terms and conditions of a contract or agreement between the PI and the funding source.
Our team will facilitate this process for you in collaboration with the UCI Sponsored Projects Administration (SPA) or UCI Beall Center for Applied Innovation (AI).
The process involves understanding the funding source's terms and conditions and ensuring they are within UCI's policies and guidelines, identifying negotiable terms (e.g., budget, payment terms, intellectual property rights, publication rights, etc.), and documentation of the finalized clinical trial agreement (CTA).
Our units ensure proper financial management of your study.
- Pre-award: Once your study enters our activation process, our team aids in developing a realistic budget reflecting the proposed clinical trial's costs. We ensure all necessary expenses are considered, including salaries, equipment, and supplies. Additionally, we assist in negotiating with the funding source to address any budgetary concerns.
- Post-award: After your study begins, our team helps manage study funds and ensures accurate expense tracking. We handle creating accounts, budget management, expense tracking, sponsor invoicing, and fund distribution.
Our teams will also conduct coverage analysis. This is a comprehensive review of the clinical trial protocol, applicable regulations and the specific patient population to determine which costs related to the trial will be covered by the sponsor, insurance and patients.
Principal Investigators (PIs) must record all UCI clinical research studies on OnCore CTMS, a web-based application that supports clinical research study management. It integrates the Epic Electronic Medical Record (EMR) system to provide a comprehensive view of study progress and status. OnCore also allows users to manage:
- Study protocols
- Budgets
- Contracts
- Regulatory compliance
- Subject enrollment
- Data collection
- All other aspects of clinical trial management
OnCore CTMS helps streamline clinical trial operations, improves study quality, and ensures compliance with regulatory requirements.
The UCI OnCore Support team can assist you with system set-up and training.
Document alignment is an important and institutional requirement for PIs to ensure that all documents related to a clinical trial are accurate, complete and consistent with one another to ensure financial risk is mitigated. Document alignment involves reviewing and comparing all study-related documents to identify discrepancies, inconsistencies or errors that could impact the study.
Once alignment is complete, the start-up team submits Kuali Research (KR) signoff in order to execute the contract and allow the study to open.
Contact Our Business Development Team
Thank you for your interest with our team.
One of our specialists will be in contact with you soon.