Clinical Research Coordinator Ii

3 days ago

Guelph, Canada Nutrasource Full time

Job Overview:
The Clinical Research Coordinator 2 (CRC 2) is responsible for assisting with and leading research study activities, assisting in project planning and set-up, and ensuring that the clinic trial site staff follow specific requirements of the protocol, regulatory requirements, and Nutrasource policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs). This role coordinates research participants, as well as the provisioning of administrative and staff services to Project Management, the Clinic Manager, and Investigators.

Primary Responsibilities:

- Coordinates or co-leads assigned clinical research projects in accordance with Protocols, SOPs, WIs, and applicable regulations
- Coordinates or co-leads study types such as BA and BE studies, Phase 1 - 4 studies, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) studies and all phases of the studies as assigned
- Acts as a co-Lead CRC or Lead CRC on studies, including planning and preparing for studies as follows:

- Assists and/or leads in the review of assigned protocols and other protocol documentation (ICF, IB, electronic Case Report Forms (CRFs), Study Specific Procedures, Study Laboratory manual) for accuracy, feasibility, timing, and resources
- Coordinates and assists the Recruitment team in pre-screening activities and recruitment of study participants
- Assists and/or leads in the preparation and maintenance of the Investigator Site File (ISF) for the study
- Participates in study start-up meetings (Investigator Meetings, Site Initiation Visits, Sponsor discussions, or other related meetings)
- Coordinates all required start-up activities including, but not limited to, the following:

- Clinic logistics planning, schedule of clinic activities, and team training
- Preparing, reviewing, and/or finalizing clinic source documents, time and events tables, and other required study materials
- Reviewing Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules
- In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) review, pharmacy/ dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
- Confirmation that all required regulatory and contractual documentation is present prior to study start
- Planning and collaboration with vendors (safety laboratory, bioanalytic lab) for study set-up
- Assists in budget allocation to conduct study requirements and communicates with the clients and vendors as needed.
- Performs the following during the conduct of a clinical trial:

- Coordinates screening activities and provides support as required
- Coordinates and ensures set-up of clinic rooms, participant chart review, and source document preparation prior to start of clinic activities
- Takes the lead and/or coordinates overall clinic activities including, but not limited to:

- Supervising clinic visits (admission, dosing and randomization, discharge, and follow-up) as required
- Ensuring volunteer eligibility prior to randomization
- Assists with and performs drug administration and other activities as delegated and required
- In collaboration with the responsible teams, ensures that all study-related activities are conducted according to protocol, SOP, WIs, and applicable regulations
- Manages clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and trackers, quality control, and monitor findings
- Maintains and updates the Investigator Site File (ISF) accordingly
- Escalates observations to Lead CRCs and Investigators as appropriate
- Performs the following after the in-participant phase of the clinical study and in preparation for site close-out:

- Ensures resolution and/or addresses QC, monitor, or other internal/external findings
- Oversees close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
- Responsible for updates of ISF documentation
- Finalizes study and/or participant logs
- Ensures completion of other close-out activities as required (return of study supplies, REB reports, archiving, etc.)
- Submits participant reimbursement requests at the conclusion of their participation in the study
- Monitors participants’ compliance throughout the study
- Addresses day-to-day participant or study issues and escalates as appropriate
- Prepares for and participates in regulatory inspections, sponsor or internal QA audits and monitoring visits
- Provides accurate and timely project status updates to Project Managers
- Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company-related initiatives and goals
- Accommodates flexible schedule (available days, afternoons, nights, and weekends)
- Minimal travel may be required (up to 25%)
- Any ad hoc duties as assigned by Lead

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