Site Care Partner – Lead CRA

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

📋 Description

• Act as a vital liaison for investigative sites throughout the duration of a study.

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

• Assist in country and site selection activities, which includes reviewing site lists and qualifying sites.

• Provide insights on protocol feasibility, standard care practices, and medical procedures at the country/regional level.

• Execute site start-up tasks, including site qualification, activation checklists, ICF finalization, and SIV as needed.

• Organize site initiation training and complete the necessary documentation and systems for activation.

• Ensure follow-up actions are completed post site qualification visits and SIV to prepare sites for FSFV.

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

• Cultivate and sustain relationships with site organizations, strategic partners, investigators, and site personnel.

• Facilitate communication and resolution of escalated site issues, including those related to vendors, contracts, and payments.

• Oversee strategies for investigational products and ancillary supply requirements in the country.

• Assist in recruitment planning and delivery that aligns with global, country, and local objectives.

• Work alongside regulatory bodies and study start-up teams to finalize country/local registries.

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

• Aid study management with local import/export mandates for investigational products and supplies.

• Review site reports and address related issues.

• Ensure quality and consistency in monitoring delivery.

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

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

• Adhere to Parexel processes, ICH-GCPs, and relevant regulations.

⛳️ Requirements

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

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

• Strong communication, presentation, and interpersonal abilities.

• Capability to manage necessary travel obligations.

• Proven networking and relationship-building skills.

• Demonstrated capacity to manage cross-functional relationships.

• Effective communication with both internal and external stakeholders.

• Flexibility to adapt to evolving technologies and processes.

• Awareness of country-specific GCP requirements that may differ from client procedures.

• Competence in overcoming obstacles encountered during the implementation of new systems and processes.

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

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

• Capability to address issues escalated by site staff in a manner that satisfies both the client and the site personnel.

• Proven experience in site management with a background as a CRA.

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

• Experience in conduct and closure activities.

• In-depth knowledge of quality and regulatory requirements in relevant countries.

• Bachelor's degree or RN in a related field or an equivalent mix of education, training, and experience (minimum of 5 years’ experience is estimated).

• Proficiency in English is required; local language proficiency is preferred.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible work arrangements to promote work-life balance.

• Competitive salary and performance-based incentives.