Site Care Partner

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

📋 Description

• Act as a vital point of contact for investigative sites throughout the entire study lifecycle.

• Qualify and activate designated sites while implementing client site strategies.

• Assist with country and site selection, feasibility strategies, analytics, and protocol feasibility tasks.

• Provide country and regional insights for strategy formulation, feasibility, protocol design, and outreach surveys.

• Execute site start-up processes, which include site qualification, coordination of activation checklists, finalization of ICF, and SIVs as necessary.

• Address any issues that could delay site activation and ensure sites are prepared for FSFV.

• Collaborate with CRAs to guarantee monitoring readiness and successful enrollment delivery.

• Establish and nurture relationships with investigator sites, site organizations, and strategic partners.

• Oversee the resolution of elevated site issues, including vendor, contract, and payment matters.

• Manage strategies for investigational products and ancillary supplies throughout the study lifecycle.

• Work alongside regulatory authorities and study start-up teams to complete country and local registry requirements.

• Collect country and regional intelligence to provide site recommendations and performance insights.

• Assist in defining import/export requirements for investigational products and ancillary supplies.

• Review site reports and related issues during the study execution phase.

• Evaluate and update SMO assessments and continuity/contingency plans.

• Support decentralized capabilities, address issues, and explore client pipeline opportunities at investigator sites.

• Serve as a subject matter expert on client systems and processes as needed.

• Develop efficiencies and best practices to enhance site performance and investigator/site satisfaction.

• Ensure clear communication with study teams and support CRA-investigator relationships.

• Fulfill required training, complete timesheets, submit expense reports, update CVs, and adhere to Parexel processes, ICH-GCPs, and relevant requirements.

⛳️ Requirements

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills and a willingness to adopt new technologies.

• Outstanding communication, presentation, and interpersonal abilities.

• Capability to manage necessary travel.

• Skills in networking and building relationships.

• Proficiency in managing cross-functional relationships.

• Effective communication with both internal and external stakeholders.

• Ability to adapt to evolving technologies and processes.

• Knowledge of country-specific GCP regulations.

• Experience in overcoming challenges during the implementation of new processes and systems.

• A minimum of 5 years of prior experience as a CRA in clinical research or pharmaceutical organizations.

• Experience in reviewing monitoring reports.

• Background in start-up activities through site activation.

• Experience in conduct and close-out activities.

• Understanding of quality and regulatory requirements in relevant countries.

• Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.

• At least 5 years of experience when qualifying through equivalent education, training, and experience.

• Proficiency in English is required.

• Proficiency in the local language is preferred.

• Oncology monitoring/CRA experience is preferred.

🏝️ Benefits

• Equal opportunity employer.

• Comprehensive training curriculum provided.

• Expense reimbursement through required expense reports.