Site Activation Partner

Pharmaceutical Research Associates, Inc; Canada; Remote; CAD 70,000 - 90,000; Full time

Job summary

A global clinical research organization is seeking a Site Activation Partner. This role involves supporting clinical trial site activation and ensuring compliance with regulations. The ideal candidate has at least 2 years of related experience in clinical trials support, knowledge of regulatory requirements, and strong communication skills. This position offers an opportunity to work within a multinational team in Canada.

Qualifications

• Minimum of 2 years of related experience.
• Experience in clinical trials support or pharmaceutical industry required.
• Fluent in English and the regulatory language of the location.

Responsibilities

• Assist with study site activation activities to ensure timely site activation.
• Act as a point of contact for GSSO team members for project site communications.
• Support the SRP with coaching and training of site personnel to ensure compliance.

Skills

Knowledge of ICH and local regulatory authority drug research and development regulations

Effective communication skills

Organizational and multitasking skills

Ability to work independently and as part of a team

Basic medical terminology, GCP knowledge, and computer proficiency

Understanding of operational elements of a clinical trial

Education

School diploma/certificate or equivalent; BS/BA in life sciences preferred

Tools

PC-Windows

Job description

Overview

As a Site Activation Partner, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

Le partenaire d'activation du centre de l’étude est chargé de soutenir les activités opérationnelles liées à l’évaluation, l'activation, l'initiation, la surveillance et la clôture des centres/études des chercheurs assignés, afin de garantir le respect des délais de l’étude et conformément aux lois, aux bonnes pratiques cliniques et aux normes en vigueur.

Vous fournirez un soutien technique et logistique aux SRP pour assurer l’initiation des chercheurs et le démarrage de l’étude.

Responsibilities

What you will be doing:

Clinical Trial Site Activation & Conduct

• Assist with study site activation activities to ensure timely site activation.
• Register investigator sites in registries as required.
• Support and/or coordinate central Investigator Review Board (IRB) submissions when needed.
• Work with investigator sites to complete critical information for site activation, including Investigator Initiation Packages (IIP), confidentiality agreements, study contracts, clinical supply shipment information, payment information, IRB submission and status.
• Support local IRB workflow from submission through approval and report updates to safety information.
• Follow-up with investigator sites on the status of study documentation and resolve or escalate issues promptly.
• Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572 revisions within required timelines.
• Communicate site approvals to SRPs, Study Start-Up Project Managers, and relevant study team members.
• Assist with the preparation, handling, and distribution of Clinical Trial Supplies and maintain tracking information.
• Work with investigator sites to complete ongoing study documents like protocol amendments and FDA 1572 revisions.
• Assist with tracking and managing Case Report Forms (CRFs), queries, and clinical data flow.
• Submit all required documentation, updates, and tracking within deadlines, including Trial Master File documentation, site activation status, protocol amendment status.
• Problem solve issues with timely escalation to the SRP.
• Assist the SRP in preparing, handling, distributing, filing, and archiving clinical documentation and reports.
• Support investigator sites, SRPs, Study Managers, and study teams in preparation for and responses to site audits/inspections.

Communication

• Act as a point of contact for GSSO team members for project site communications and documentation.
• Maintain ongoing contact with GSSO team members as needed.
• Respond promptly to requests from GSSO team members and investigator sites.
• Establish tools for efficient updates on site status, issues, delays, and approvals.

Clinical Trial Monitoring Support

• Support the SRP with coaching and training of site personnel to ensure compliance with study documentation, laws, GCP, and standards.
• Collaborate with SRP to conduct or oversee investigator site activation, IIP completion, budget and contract negotiation, and manage emerging issues.
• Facilitate site payments as needed and resolve related issues.
• Conduct remote monitoring activities focusing on Trial Master File reconciliation, investigational product reconciliation, and other logistical activities.
• Identify and resolve investigator site issues with the partner chargé des relations avec le centre within required timeframes; develop corrective and preventative actions.
• Assist in resolving data queries within timelines; support database releases as needed.

Qualifications

• Minimum of 2 years of related experience.
• Experience with PC-Windows, word processing, and electronic spreadsheets required.
• Knowledge of ICH and local regulatory authority drug research and development regulations required.
• Clinical trials support or pharmaceutical industry experience required.

Preferred

• School diploma/certificate or equivalent; BS/BA in life sciences preferred.
• 2 years relevant experience in clinical site management.
• Experience in study activation and site management is an asset.
• Knowledge of clinical trial methodologies, ICH/GCP, FDA, and local regulations.
• Fluent in English and the regulatory language of the location.

Skills

• Knowledge of global and local regulatory requirements.
• Understanding of operational elements of a clinical trial.
• Compliance with company, regulatory, and country requirements.
• Ability to work independently and as part of a team.
• Organizational and multitasking skills.
• Basic medical terminology, GCP knowledge, and computer proficiency.
• Effective communication skills.
• Support for multi-national team members; flexibility in working hours may be needed.

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