Clinical Trial Coordinator

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 indicators

OPU 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 activities	Ensuring 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 for the SAE Queries and Mailbox o Responsible to process ethics invoices o Responsible to manage the updates and revisions to KMed documentation o Drug Shipment mailbox and workflows o Responsible to support Investigational supplies to coordinate the shipment, collection and return of equipment and supplies from sites o Support Management of calibration validity of sponsor loaned equipment	Appropriate communication of administrative content to the clinical team and vendors, escalating as needed to appropriate stakeholders. Ensures accurate trackers available to the applicable stakeholders, as needed.
Archiving of physical and non-physical records o Responsible for management of off site storage and archiving of site and pharmacy documentation o Responsible for the Management of off site archival storage with vendor o Acts as local Archivist and Custodian for CD&O Support Audits and Inspection with document retrieval o Responsible for the share room archive and common drive clean-up.	Archiving is performed in alignment of corporate retention timelines and to ensure documented service levels by the vendor are adhered to.
Support site engagement by working with investigators and site staff to mitigate any issues identified during start up, conduct and closeout as delegated by the CTM.	Site engagement and support to mitigate issues.
May support local and/or global process improvement initiatives.	As appropriate, based on assignment.

Regulatory and/or Organizational requirements
Acts in compliance with internal and external standards (e.g. ICH-GCP, Good Documentation Practice, SOPs, WIs and local procedures and regulations).



Job Complexity:
Job involves an excellent working knowledge of document regulatory requirements, the ability to work in an IT system and communicate effectively with internal teams and vendors.



Interfaces:
Job liaises principally remotely with investigational site staff and third party vendors- Clinical Trial Manager (CTM)

• Clinical Research Associate (CRA)
• Investigational supplies
• Third party vendors as required (eg. for documentation or other services)
• Any other relevant function(s) (internal or external),as needed

Job Expertise*

• Highly developed administrative skills, excellent document management and organizational skills
• Strong knowledge of ICH-GCP and local regulatory regulations
• Capable of managing multiple assignments and able to work independently.
• Strong verbal and written communication skills
• Fluency in English, written and verbal
• Strong MS-Office skills (Excel, Word, Power Point, Outlook etc.)

Job Impact*

• Ensures that essential documents collected from the investigational site meet the document requirements regarding content and quality.
• Ensures site document collection and archiving is achieved within required trial and retention time lines.
• Essential function for timely trial and site start-up, database lock and archiving.

Minimum Education/Degree Requirements*

• Minimum high school degree preferably Post Secondary Education in Business Administration or equivalent.

Required Capabilities (Skills, Experience, Competencies)*

• Strong knowledge of ICH-GCP guidelines and local document regulations.
• Good understanding of the drug development process.
• Excellent organizational & communication skills.
• Customer oriented thinking in communication with investigational sites.
• Demonstrated ability to work effectively in a team environment.
• Have the ability to learn and grasp IT systems quickly with minimum effort.
• High precision in daily work with a strong focus on quality.
• Good responsiveness and ability to cope with multiple requests in stressful situations
• Highly committed to timelines.
• Proficiency in office software.
• Clinical Trial experience (Clinical trial assistant, Clinical Research Associate –CRA) and knowledge of ICH-GCP is an asset for new comers
• Familiar with use of electronic tools (excel, systems, MS Office, etc) and computer skills
• Organizational skills
• Flexibility
• Fluency in English, written and verbal
• Ability to work independently / solution oriented

Problem Solving:

• Entry level: Developing 1 year: Demonstrating
• Escalates issues and problems as appropriate. With support, identifies root cause(s) of problem based on facts and evidences; anticipates obstacles, and considers different approaches to the decision-making process; develops practical and timely solutions while considering the impact of the solutions.

Teamwork and Collaboration:

• Entry level: Developing 1 year: Demonstrating
• Obtains and shares appropriate information, ideas, and problems in a timely manner; collaborates with team members; draws on the strengths of colleagues; places high priority on team/organizational needs.

Project Management:

• Entry level: Developing 1 year: Demonstrating
• Prioritizes plans and time lines based on potential risk identification and monitors a course of action in consultation with the CTM; provides regular updates to CTM to ensure trial plan is on track; recognize the impact of tasks/risks to other team members and sites.

Communication:

• Entry level: Developing 1 year: Demonstrating
• Obtains and shares appropriate information, ideas, and problems in a timely manner; expresses messages and data in an understandable, engaging and focused way.

Accountability:

• Entry level: Developing 1 year: Demonstrating
• Takes appropriate actions to ensure obligations are met in a timely manner; shows ownership for personal decisions and actions in all situations; takes accountability for mistakes and is open to sharing lessons learned; accepts accountability for team deliverables where appropriate.

Knowledge:

• Technical/systems: Within 6 months demonstrates a working or functional proficiency level associated with technical/systems required to oversee clinical trials.
• Clinical Research Environment: Demonstrates a working or functional understanding of the requirements of the clinical research environment (Sponsor, Investigator and Regulatory).
• SOP/Guidelines: Within 6 months demonstrates a clear understanding and ability to reference as appropriate.

Special Skills:

• Legal/contractual and budgetary activities: Demonstrates in depth understanding of legal/contractual activities and budgeting for clinical studies; at entry demonstrates at least a minimal proficiency level of contractual and budgetary requirements, within 6 months demonstrates a working or functional proficiency level
• Strong financial and business acumen. At entry demonstrates at least a minimal financial and business understanding for clinical trial business requirements; within 6 months demonstrates a working or functional proficiency level of business related aspect of clinical trials.
• Excellent negotiation; At entry demonstrates at least a minimal contract negotiation proficiency level, within 6 months demonstrates a working or functional proficiency level for negotiating clinical contracts
• Highly developed analytical and problem solving skills and excellent mentoring and leadership skills.
• Advance knowledge of PC software: Demonstrates working and functional proficiency of programs such as MS Word, Excel and PowerPoint.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical