Clinical Research Coordinator

**Job Overview**:
The **Clinical Research Coordinator 1** (CRC 1) is responsible for research study activities such as assisting in study planning and set-up. They will be required to follow specific requirements of study protocols, regulatory requirements, policies, Standard Operating Procedures (SOPs) and Work Instructions (WI). The CRC 1 will also be required to recruit and coordinate research participants, as appropriate. This is a casual / part time role.

**Primary Responsibilities**:

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

- Assists in 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
- Assists the Recruitment team in pre-screening activities and recruitment of study participants
- Assists 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)
- Assists in all required start-up activities including, but not limited to, the following:

- Clinic logistics planning, schedule of clinic activities, and team training
- Preparing clinic source collection documents, time and events tables, and other required study materials
- Reviewing CRFs, laboratory workbooks, staff requirements, and schedules
- In collaboration with the responsible teams, establishing and/or maintaining 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 monitoring budget allocation during the study and escalates as needed to the study lead
- 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
- Assists and/or coordinates overall clinic activities including, but not limited to:

- Assist in supervising clinic visits (admission, assist in dosing and randomization, discharge, and follow-up) as required.
- Ensures 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, SOPs, WIs, and applicable regulations
- Manages clinic updates, Adverse Event (AE) or Serious Adverse Event (SAE) reporting, study logs and trackers, quality control, and monitor findings
- Assists with maintenance and updates to 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
- Assists in close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation
- Assists in updates of ISF documentation
- Assists in finalizing the study and/or participant logs
- Ensures completion of other close-out activities as required (return of study supplies, REB reports, archiving, etc.)
- Assists in the submission of 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 regulatory inspections, sponsor or internal QA audits and monitoring visits
- Provides accurate and timely project status updates to Lead CRCs
- 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 schedules (available days, afternoons, nights, and weekends)
- Minimal travel may be required (up to 25%)
- Any ad hoc duties as assigned by Lead CRCs and Investigators
- Other duties as may be required and as training and experience allow
- Promotes GXP compliance across the organization
- Maintain