Site Activation Partner I – FSP, Fixed-Term 7 months

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead or assist in operational tasks from study initiation to closure for designated studies and investigator sites.

• Ensure adherence to study timelines, applicable laws, Good Clinical Practices, and client standards.

• Initiate and manage start-up activities along with essential document management to create high-quality Investigator Initiation Packages and achieve site initiation approval.

• Address or escalate site-related issues and coordinate support roles to ensure timely site activation.

• Prepare, validate, and submit regulatory documents, including IIP, IRB approval forms, and FDA 1572/Attestation Forms.

• Assist with Central Investigator Review Board packages and submissions required by the country.

• Coordinate communications and responses between clients and central ethics committees.

• Aid investigator sites with local IRB preparation, submission, and approval workflows.

• Prepare, manage, and distribute clinical documentation and reports.

• Support and execute Shared Investigator Platform activities that align with client strategy.

• Oversee essential documents and updates throughout the study, including protocol amendments, FDA 1572/Attestation revisions, and annual ethics committee approvals.

• Maintain activities related to the IRB/Ethics Committee.

• Organize documents in the Trial Master File and assist with periodic quality reviews.

• Update and maintain clinical trial systems that track site compliance and performance.

• Assist investigator sites and study teams with responses to audits and inspections.

• Maintain ongoing communication with study teams and investigator sites.

• Provide functional updates at both country and site levels and establish tools for effective status reporting.

• Distribute ethics approvals and inform stakeholders about local site approvals.

• Conduct awareness sessions for site personnel as required.

• Identify and mitigate site issues while coordinating corrective and preventive actions.

• Act as a point of contact or subject matter expert for the Site Activation Partner role as assigned.

• Represent the SAP function in systems, processes, and global initiatives.

• Mentor new team members on processes and systems.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Maintain knowledge of and adhere to Parexel processes, ICH-GCP, and applicable requirements.

⛳️ Requirements

• Minimum of 2 years of start-up experience, including familiarity with US/CAN.

• Understanding of clinical research and development processes along with key operational aspects of a clinical trial.

• Knowledge of quality expectations and a right-first-time approach.

• Compliance with relevant company, regulatory, and country requirements.

• Strong attention to detail and a disciplined work ethic.

• Ability to work both independently and collaboratively within a team.

• Capability to organize tasks, manage time and priorities, and multitask effectively.

• Basic understanding of medical terminology.

• Knowledge of GCP requirements.

• Proficient in computer operations.

• Ability to learn and utilize systems independently.

• Proficiency in Microsoft Suite.

• Experience with Clinical Trial Management Systems (CTMS).

• Familiarity with electronic Trial Master File and electronic Investigator Site File systems (e.g. Florence).

• Experience with document exchange portals, the Shared Investigator Platform, and ethics, national networks, and governing bodies portals/platforms as required.

• Willingness to work off-hours in a global context when necessary.

• Ability to travel as needed, including potential international travel.

• Previous experience in the pharmaceutical industry or CRO in study site activation is preferred.

• Knowledge of clinical trial methodologies, ICH/GCP, FDA regulations, and both global and local country regulations.

• Fluency in the local language and English is mandatory.

• Multilingual capabilities are preferred.

• For candidates located in Canada, bilingualism in French and English is preferred.

• Strong verbal and written communication skills.

• Good technical skills with the ability to learn and utilize various systems.

• A high school diploma or certificate with a suitable combination of education, training, and experience, or a Bachelor of Science/Bachelor of Arts or equivalent.

• A minimum of 2 years of relevant experience in clinical site management.

🏝️ Benefits

• 7-month temporary assignment with the possibility of transitioning into a full-time position.

• Full-time employment opportunity.

• Potential for international travel.