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 9 month contract, with a guaranteed 30 hours per week.

EDUCATION AND EXPERIENCE:

• A minimum of a BA/BSc degree is required; a degree in a health, science or research related fields is preferred
  · Pharmaceutical and/or clinical trial experience is preferred; specific therapeutic area experience is an asset for the position
  Job Types: Part-time, Fixed term contract
  Contract length: 9 months
  Expected hours: 30 per week

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift

Work Location: In perso

• 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

o 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

o 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.)

o 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

• Maintains an attitude and philosophy consistent with the Company’s standards