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Site Activation Partner

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Parexel

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Location:
Canada , Ontario

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.

Job Responsibility:

  • Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation
  • Register investigator sites and Client stakeholders in Client registries and systems as required
  • Work directly and interact with investigator sites to confirm readiness for site start-up by reviewing study site profile ready in Shared Investigator Platform (SIP) or reviewing/completing critical information Sheet
  • Take the lead to resolve issues or concerns and timely escalation of Site issues where applicable
  • Prepare, validate and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines
  • Manage and coordinate with other supporting roles to ensure timely site activation and operational activities
  • Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study
  • Coordinate the timely communication, documentation and responses between Client and Central Ethics committee to bring clinical study to approval
  • Support investigators sites with local IRB workflow from preparation, submission through approval
  • Assist with preparation, handling and distribution of non-Clinical Trial Supplies and maintenance of tracking information as needed
  • Collaborate with the Study Team on the development and readiness of sites electronic Investigator Site File (eISF)
  • Assist with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports
  • Support & implement activities in SIP to align with Client strategy as it relates to the role
  • Coordinate translation of documents that are within scope with the preferred translation vendors
  • Post site activation, initiate and coordinate activities and essential documents management with the investigator's sites towards the compilation of a high-quality documents and updates through the life cycle of a study
  • Ensure maintenance of IRB/Ethics and other committees' activities as applicable
  • Responsible for timely filing of documents to Trial Master File and assisting with periodic quality review of study files for accuracy and completeness
  • Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines
  • Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections
  • Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests
  • Attend study Start-up meeting and provide functional updates on a country and site level
  • Establish tools for efficient updates to study team as needed regarding site status, issues, delays, approvals
  • Disseminate Central or Local Ethics Approval to study team and Investigator Sites where applicable
  • Communicate Local sites approvals to study team members and stakeholders
  • As needed, perform awareness session with site personnel on Client requirements and to ensure ongoing compliance with study documentation

Requirements:

  • Minimum 2 years’ direct experience in Study Start Up
  • Experience working in the pharmaceutical industry/or CRO in study site activation is required
  • Knowledge of clinical trial methodologies, ICH/GCP, FDA and Global and local country regulations
  • Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization
  • Good technical skills and ability to learn and use multiple systems
  • Demonstrated knowledge of clinical research and development processes, Key operational elements of a clinical trial, and ability to gain command of process details
  • Understand the quality expectations and emphasis on right first time
  • Demonstrate compliance with all applicable company, regulatory and country requirements
  • Attention to detail evident in a disciplined approach
  • Ability to work independently and also as a team member
  • Ability to organize tasks, time and priorities, ability to multi-task
  • Understand basic medical terminology, GCP requirements and proficient in computer operations
  • Must be fluent in Local language and in English

Nice to have:

  • Multi-language capability is preferred
  • Bachelor of Science, Bachelor of Arts or Bachelor’s in Life Sciences preferred

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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