For Physicians Only

Principal Investigator (PI) Recruitment

Research Administration Department

The St. Joseph Hospital Hospital Research Administration Department supports, facilitates and coordinates the day-to-day operations of all research studies. We ensure that research is conducted in compliance with the study protocol as well as federal, state, and institutional guidelines and regulations.

We are always eager to work with new investigators. If you are interested in participating in clinical trials, the Research Administration Department can facilitate clinical research projects according to your interests. For more information, please call 714-771-8084.

The Research Administration Department assists with:

Administrative Management

  • All research-related tasks from the time of initial coordination and start-up through end of study and long-term storage of closed studies
  • Appropriately train individuals involved in the conduct of the study around issues related to protocol requirements, schedule of visits and execution of research plan
  • Maintain documentation of training for all staff
  • Coordinate and facilitate with monitoring and auditing visits

Proposal Preparation

  • Assist the PI in study feasibility assessments
  • Reviews and comprehends the protocol
  • Attends investigator meetings as required and/or requested by the PI
  • Collaborates with the PI to prepare all IRB submission documents as required by the protocol
  • Prepares study materials, including informed consent forms, case report forms (CRFs), enrollment logs, and drug/device accountability logs
  • Establishes and organizes study files

Proposal Budget and Financial Management

  • Collaborate with PI and Contracts Department to prepare a categorized budget
  • Confirms accuracy and completeness of budgeted costs by working collaboratively with CORA
  • Coordinates appropriate and timely submission of payments by assessing billing notices with study visit schedule of events
  • Reviews billing entries to facilitate billing of study procedures to the appropriate account

Conduct of Research

  • Reviews and develops familiarity with the protocol (study proceedings and timelines, inclusion and exclusion criteria, and confidentiality and privacy protections)
  • Assist PI with communication of study requirements to all individuals involved in the study
  • Collects documents needed to initiate the study and submit to the sponsor
  • Works with PI to develop and implement recruitment strategies
  • Assists in the informed consent process, including discussions with research participants and answering questions related to the study
  • Screens subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion
  • Registers participants though study-related EDC systems
  • Registers each participant in the electronic billing system to ensure accurate billing of study procedures to the appropriate funding source
  • Coordinates participant tests and procedures
  • Collects data as required by the protocol and assures timely completion of CRFs
  • Maintain study timelines
  • Maintains adequate inventory of study supplies
  • Completes study documentation and maintain study files
  • Retains all study records
  • Maintains effective, ongoing communication with sponsor, research participants and PI during the course of the study

Clinical Research Coordinators

Laura Ramirez, B.S., CCRC
714-771-8084
Monica Arroyo, CCRP
714-771-8000, ext. 13615

Address:

St. Joseph Hospital
Office of Research Administration
1100 West Stewart Drive
Orange, CA 92868