Site Care Partner

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

📋 Description

• Implement client site strategies by assessing and activating designated sites.

• Assist in country and site selection processes, including evaluating site lists and qualification results.

• Provide regional or country insights on protocol feasibility, standard medical practices, and care.

• Execute site start-up tasks, such as site qualification, coordinating activation checklists, finalizing informed consent forms (ICF), and conducting Site Initiation Visits (SIV) as necessary.

• Address issues that could delay site activation timelines.

• Finalize site initiation training, documentation, and systems essential for activation.

• Aid in the review and deployment of country-specific ICFs.

• Complete follow-up tasks after site qualification visits and SIVs to ensure that sites are prepared for First Subject First Visit (FSFV).

• Collaborate with Clinical Research Associates (CRA) to guarantee site monitoring readiness and successful enrollment.

• Foster and nurture relationships with site organizations, strategic partners, investigators, and site personnel.

• Manage communication and resolution of escalated issues regarding site delivery.

• Ensure that Investigational Product (IP) and ancillary supply strategies align with site and country needs throughout the study.

• Strategize and implement site recruitment in accordance with global/country plans and local objectives.

• Collaborate with regulatory bodies and study start-up teams to finalize country/local registries through site activation.

• Offer site recommendations and local insights based on knowledge of country, site processes, practices, and performance.

• Assist study management with local investigational product import/export regulations.

• Review site reports and associated issues.

• Ensure quality and consistency in monitoring outcomes.

• Support CRA in maintaining investigator relationships and escalate any training or compliance issues.

• Complete necessary training, timesheets, expense reports, and curriculum vitae updates.

• Adhere to Parexel's processes, ICH-GCP standards, and relevant regulatory requirements.

⛳️ Requirements

• Understanding of Good Clinical Practice (GCP)/ICH Guidelines and other relevant regulatory requirements.

• Must exhibit strong computer skills and be open to adopting new technologies.

• Excellent communication, presentation, and interpersonal skills.

• Ability to manage necessary travel commitments.

• Proven networking and relationship-building capabilities.

• Demonstrated aptitude for managing cross-functional relationships.

• Ability to communicate effectively and appropriately with both internal and external stakeholders.

• Capacity to adapt to evolving technologies and processes.

• Familiarity with country-specific GCP requirements that may differ from client procedures.

• Ability to effectively navigate challenges faced when implementing new processes and systems.

• Identifies and establishes effective relationships with investigator site personnel and other stakeholders.

• Strong verbal and written communication skills in interactions with colleagues and associates, both within and outside the organization.

• Capable of addressing issues raised by site staff in a manner that satisfies both the client and site personnel.

• Proven experience in site management, with previous experience as a CRA.

• Demonstrated expertise in start-up activities leading to site activation.

• Proven experience in conducting and closing out study activities.

• Strong knowledge of quality and regulatory standards applicable in relevant countries.

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

• Proficiency in the local language is preferred.

• Proficiency in English is required.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.

• Supportive team environment and company culture.