Site Care Partner – Lead CRA

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

📋 Description

• Responsible for the initiation and activation of sites.

• Implement Global Site and Study Operations (GSSO) strategies by qualifying and activating designated sites.

• Assist in optimizing country and site selection processes, including reviewing and evaluating potential site lists and providing Pre-Trial Assessment (PTA) outputs for site selection.

• Collaborate with key stakeholders to provide regional input for country outreach surveys, including protocol feasibility and local standard of care and medical practices as applicable, under supervision.

• Perform study initiation activities at the site level, which include PTA, coordinating site activation checklist items, finalizing Informed Consent Documents (ICDs), and managing issues that could delay site activation.

• Ensure completion of all site initiation tasks, including training per the site activation checklist and the collection of necessary documentation/systems required for site activation (e.g., PSR, SART, ESRA, SAC, FU Letter, Planisware, ISF/eISF, etc.).

• Provide support for country-specific ICD review and deployment when necessary.

• Ensure the completion of follow-up activities post-PTA and SIV to confirm site readiness for First Subject First Visit (FSFV).

• Collaborate with the site monitor to ensure readiness for monitoring in anticipation of the first subject's visit.

• Address escalated site issues related to study delivery by coordinating communication and resolution efforts (e.g., vendor, site contracts, and payment issues).

• Ensure the strategy and approach for Investigational Product (IP) and ancillary supplies meet site and country requirements throughout the study lifecycle.

• Accountable for effective site recruitment planning and execution, aligning with global and/or country plans and local targets; responsible for enrollment support and addressing recruitment challenges raised by investigators.

• Maintain regular contact with investigator sites to gather updates on status and drive progress towards study goals (e.g., recruitment, data entry timelines, etc.).

• Collaborate with local Regulatory Affairs (RA), Clinical Trial Research Organization (CTRO), and Study Administration Personnel (SAP) to ensure timely completion of country/local registry requirements when applicable.

• Responsible for study execution and close-out activities.

• Serve as the operational contact for all site-level inquiries, liaising with and escalating to appropriate teams to address and resolve questions.

• Review Site Monitoring Reports and assist the site with the revision and submission of ICD documents (and amendments).

• Collaborate with other roles to maintain system management (e.g., EDC, Shared Investigator Platform, Site Profile, and other applicable systems) at the site level, ensuring alignment across platforms.

• During the study, review the Site Management Organization Assessment with the site on an annual basis following site initiation and update it as necessary under DCSO/Senior SCP supervision.

• Additionally, update the SMO Assessment when significant changes occur at the site, including staffing or contracting issues, to ensure continuity and current contingency plans.

• Review and address any site practices that deviate from client practices, collaborating with study management and Business Process Owners as needed.

• Maintain consistent communication with investigator sites to gather status updates, informal and formal performance metrics, and feedback at the study level.

• Oversee and manage site deliverables to meet study targets, including data cuts/sweeps, interim analyses, database locks, and ensuring all site-facing deliverables, such as investigator signatures, are up to date.

• Follow the study oversight plan and proactively implement mitigations for known or anticipated risks.

• Support the development and delivery of decentralized capabilities at investigator sites, such as home health, ePRO, and DTP.

• Ensure quality and consistency in monitoring delivery and promote efficiencies and best practices for the study, region, and program.

• Contribute to shaping the local clinical development environment to enhance the client's reputation in scientific leadership.

• May serve as a Subject Matter Expert on client systems and processes.

• Actively seek efficiencies and develop best practices to enhance site performance throughout the study lifecycle, increasing investigator/site satisfaction and strengthening site relationships.

• Assist the site monitor in cultivating positive relationships with investigators throughout the study and escalate any training or compliance issues with the Country Trials Manager and Study Management.

• Responsible for proactively providing local intelligence.

• Contribute to site recommendations based on a deep understanding of the country/region, sites, processes, practices, and related site performance metrics.

• Provide assistance to the Study Operations Manager/Global Study Manager in defining local requirements for the import/export processes of investigational medical products and ancillary supplies.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field or an equivalent combination of education, training, and experience (minimum of 5 years’ experience preferred).

• Strong communication skills to interact effectively with both internal and external stakeholders.

• Ability to adapt to evolving technologies and processes.

• Proven skills in networking and building relationships, managing cross-functional collaborations.

• Demonstrated experience in site management, with prior experience as a site monitor.

• Proven track record in full lifecycle activities, from start-up/site activation through to closeout.

• Knowledge of quality and regulatory standards relevant to the country of the role.

• Familiarity with Good Clinical Practice (GCP), International Council for Harmonization (ICH) Guidelines, and other applicable regulatory requirements.

• Willingness to travel up to 75% regularly.

• Proficiency in the local language; English proficiency required.

🏝️ Benefits

• Health insurance

• Opportunities for professional development

• Flexible working hours