Skills

Monitoring Organization GCP

Job Specifications

Job Title: Clinical Trial Coordinator

Location: Burlington, Ontario

Type: Contract

Compensation: $25 hourly CAD

Contractor Work Model: Hybrid

Title of Position: Clinical Trial Coordinator

Contract length: 12 month renewable increments

Location: Hybrid 50% On site - 5180 S Service Rd, Burlington, ON L7L 5H4, Canada

Pay Rate: 25 / hr CAD

Accountabilities: Clinical Trial Supplies Planning

Related Performance Indictors:

Participate and provide expertise/input in Trial Start Up meetings and Local Trial Oversight Meetings to ensure clinical trial supply requirements are met for local study initiations
Sourcing of all non-drug clinical supplies including tracking, maintaining, creating purchase orders and payment
Plan and manage the procurement of all identified materials in conjunction with CTSUs, Purchasing and Business Services
Coordinate the design and printing of all patient materials including sourcing of vendor, creating purchase orders, invoice approval and payment
Accountability: Ensure local supplies procedures are in compliance with regulations
Related Performance Indictors:
Support trial teams during internal audit and HPFB/FDA inspections
Review drug labels for clinical trials according to guidelines/SOPs
Liaise with regulatory bodies to ensure the importation and sourcing of packaged/labeled investigational product and ancillary supplies for clinical trials are in compliance with current regulatory requirements
Accountability: Provide expertise to clinical trial teams and trial sites regarding products; Manages overall local supply inventory
Related Performance Indictors
Initial planning and ongoing issue resolution/queries with vendors, investigator sites and trial teams
Validate and prioritize all supplies materials shipment for initiations and re-supply requests, ensuring on time arrival of supplies to support ongoing study commitments
Review required documentation for inbound/outbound supply shipments to comply with SOP and regulatory requirements, problem solve shipment issues related to delays, broker or courier
Facilitate transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate internal database software or IRT
Basic Purpose

The Clinical Trial Coordinator(CTC) is responsible to provide support to ensure regulatory and trial related requirements are met for assigned country clinical trials. The CTC ensures archiving of physical and electronic records, including management of off site storage and retrieval, share room and common drive maintenance and acts in the capacity of archivist and custodian for CD&O Canada. CTCs support inspection preparation and conduct with respect to document retrieval, ensuring the quality and comprehensiveness of the site and country level Trial Master File (TMF)according to ICH-GCP, GDP, SOPs, WIs and local procedures. They support trials teams in preparing and managing Site Release and Site Initiations including supporting site monitoring activities for initiation and close out. They support site staff and build site engagement by working to mitigate any issues identified during start up, conduct and closeout as delegated by the CTM.

Accountabilities: Related Performance indicatorsOPU and Site Release relevant documents reviewed and filed in Electronic Document Management Systems.

o Ensures all required documentation for site release and initiation are present and filed in TMF.

o Where regulatory document collection is outsourced, liaises with the CRO as needed to ensure timely processing.

o Ensures that all documents requiring translations have been completed and filed in TMF

o Manages Non French Translation of templates, to ensure adherence to process and proper filing.

o Completes/Reviews Site Release Checklist

o Assists trial study teams in audits/inspections/CAPAs

o Provides ongoing support to CTM identifying the correspondences to be filed in BIRDS

o Responsible for BIRDS Key User activitiesEnsuring EDMS documents are available and correct to support timely site release and initiation.Supports trial meetings including the following scope:

o Face-to-face meetings/internal trial meetings

o Online Investigator Meetings

o Teleconferences

o Trainings, other

o Meeting expense reimbursement processing

o Cross border spend reporting (ie. Sunshine Act)

o Other meetings as required eg. Canadian CD&O meetings

Effective organization of meetings and respective

documentation.Maintenance of trackers and activities to support trials for activities not outsourced to a CRO. Trial management teams rely on the proper tracking of a significant number of trial specific documents and activities including:

o eCTR synopsis submission and tracking to from/sites, Ethics Committees and or Health Authorities, as applicable

o Sending lay summaries, unblinding treatment

information to sites at end of trial

o Responsible

About the Company

At Joule, we believe our world is filled with possibilities - where character, integrity, and commitment drive our purpose. For over 30 years, Joule has been a trusted partner to industry-leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joule's relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joule is a System One division. Know more