Research Center Information for Investigators

The CHI Franciscan Health Research Center provides the following services:

Study selection

  • Feasibility in recruitment of pharmaceutical and device studies for physicians

Investigator training

Study implementation and administration

  • Coordination of contract and grant negotiations
  • Preparation and submission of all regulatory documents
  • Completing study-related documentation and ensuring adherence to study protocol

Clinic and patient coordination

  • Recruitment and screening of potential study participants
  • Implementation of the clinical study within the hospital and/or physician practice
  • Inservicing appropriate staff on protocol
  • Tracking participants throughout the study
  • Coordination of all clinical procedures

Study protocol delegation

All protocols are conducted under the oversight of the Principal Investigator.

Principal Investigators are assisted by Sub-Investigators, whose responsibilities include:

  • Participant Identification and screening
  • Assist with patient consenting
  • Participant physical exams and counseling
  • Conduct protocol specific physician procedures
  • Completion of appropriate source documents and clinic charting
  • Principal Investigator is responsible for oversight of study conduct and medical oversight of Sub-Investigators and Franciscan Research Center staff.

Study coordination

Each protocol is assigned a Lead Study Coordinator who is assisted by and oversees a team of professional study coordinators. Coordinator responsibilities include:

  • Patient screening and consenting
  • Collection of protocol specific laboratory specimens and study procedures
  • Diary counseling and verification
  • Study drug assignment/instructions
  • Completion of source documents
  • Scheduling follow up study visits
  • Shipping laboratory specimens

Research associates

Research associates (pharmacy technicians cross-trained in laboratory specimen processing and clinical research protocol) assist coordinators in the implementation of protocols and in carrying out protocol procedures, as appropriate. Their responsibilities include:

  • Prepare pharmacy dispensing instructions under the oversight of a registered investigational drug pharmacist
  • Medication dispensation under supervision of pharmacist
  • Maintain study drug/device inventories/accountability and other supplies as needed
  • Lab processing
  • Lab shipping

Administrative support

Regulatory Affairs Specialist

  • Protocol submissions to the MREC/IRB
  • Protocol amendment submission
  • 1572 completion and updates
  • IND Safety Report submission
  • Sponsor correspondence
  • Curriculum vitae and license updates

Financial Reporting Specialist

  • Maintain financial ledger
  • Process physician payments and patient reimbursement
  • Reversal of appropriate research charges from patient hospital account

For more information regarding CHI Franciscan Health Research

Please call 253-426-6882 or email