Research Center Sponsors - Staff
All protocols are conducted with the oversight of the principal investigator and a dedicated investigational drug pharmacist as manager.
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 medical oversight of Sub-Investigators and Franciscan Health System Research Center staff
Each protocol is assigned to a Lead Study Nurse Coordinator who is assisted by and oversees a team of trained Research Nurse Coordinators and Research Associates. Each team member is dedicated to your trial. There is an open channel of communication with each of our staff members to ensure all of your needs are met. A Research Nurse Coordinator and Research Associate are on call 24 hours a day.
Experienced Research Nurse (RN) Coordinators, including nurses certified in clinical research and critical care. 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 coordinator pages of sources documents
- Scheduling follow up study visits
- Shipping laboratory specimens
Research Associates – three licensed pharmacy technicians with extensive laboratory processing experience – 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 a pharmacist
- Maintain study drug/device inventories/accountability and other supplies as needed
- Lab processing
- Lab shipping
- Assist in the transfer of data from source document to case report form
- Reversal of appropriate research charges from patient hospital account
A full-time Regulatory Affairs Specialist who facilitates all regulatory and financial processing to include:
- Protocol submissions to the MREC/IRB
- Protocol Amendment submission
- 1572 completion and updates
- IND Safety Report submission
- Sponsor Correspondence
- Curriculum Vitae & License updates
- Maintain financial ledger
- Process physician payments and patient reimbursement
New Hire Training:
All clinical research coordinators are required to complete training to include GCP guidelines, and all study protocols currently being managed by the Franciscan Research Center.
FAA Hazardous Material Shipment Certification:
Several Research Associates and Registered Nurse have received certification.
Continuing Education Programs:
- Weekly staff meetings review updates to protocol and study progress
- Attendance at ACRP, DIA, ICAAC and other industry conferences.
Franciscan Research Center provides additional training and financial support for:
- ACRP certification for eligible clinical research coordinators.
Quality Assurance Oversight:
- Adherence to FDA regulations and ICH guidelines
- Adherence to comprehensive Franciscan Research Center Standard Operating Procedures
- Regulatory Department compliance
- Protocol Compliance and adherence. Each study is reviewed prior to monitoring visits to ensure data quality
- Periodic protocol specific in-services for Investigators and Coordinators.
- Accurate data collection, CRF completion, and query resolution
- Annual Performance Evaluations for Research Center staff