Lead CRA – Site Care Partner

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

📋 Description

• Provide essential support and engagement to investigative sites throughout the entire study lifecycle.

• Address site issues and maintain the client’s reputation.

• Act as the primary client contact for investigative sites.

• Oversee site start-up activities through to activation, which includes PTA, activation checklists, ICD finalization, and SIV.

• Assist in country and site selection efforts while offering local insights.

• Ensure completion of site initiation activities, training, documentation, and systems.

• Confirm site readiness for the First Subject First Visit and monitoring preparedness.

• Cultivate and sustain relationships with investigator sites.

• Coordinate the resolution of escalated site delivery challenges, including vendor, contract, and payment issues.

• Strategize and support site recruitment and enrollment efforts.

• Maintain consistent communication with investigator sites regarding recruitment, data entry, performance metrics, and study feedback.

• Collaborate with regulatory and site activation stakeholders.

• Serve as the operational point of contact for site-level inquiries and escalate as necessary.

• Review site monitoring reports and assist with ICD revisions and submissions.

• Oversee site-level system management across EDC, Shared Investigator Platform, Site Profile, and additional systems.

• Evaluate SMO Assessments and uphold continuity and contingency plans.

• Manage site practices that diverge from client protocols.

• Supervise site deliverables against study objectives, including data cuts, sweeps, interim analyses, and database locks.

• Collaborate with study monitors, contracts, site activation, clinical, and other functions.

• Utilize analytical tools and country intelligence to identify quality and compliance risks and develop mitigation strategies.

⛳️ Requirements

• A minimum of 5 years of experience as a site monitor, with a focus on Oncology monitoring.

• Proven experience in start-up activities leading to site activation.

• Demonstrated experience in conduct and close-out activities.

• Comprehensive knowledge of quality and regulatory requirements in relevant countries.

• Proficient computer skills and the ability to adopt new technologies.

• Strong communication skills for effective interaction with internal and external stakeholders.

• Adaptability to evolving technologies and processes.

• Excellent verbal and written communication abilities.

• Capacity to navigate barriers during the implementation of new processes and systems.

• Networking and relationship-building capabilities.

• Proficiency in managing cross-functional relationships.

• Ability to foster effective relationships with investigator site staff and other stakeholders.

• Willingness to manage necessary travel of up to 75% regularly.

• Bachelor's Degree or Registered Nurse qualification.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Opportunities for continuous professional development and training.

• Flexible work environment with remote work options.

• Comprehensive health and wellness benefits.

• Supportive and collaborative team culture.