Site Care Partner – Lead CRA

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

📋 Description

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

• Assess and activate designated sites while implementing client site strategies

• Assist in the selection of countries and sites, which includes reviewing the site list and site qualification

• Offer insights at the country/regional level regarding protocol feasibility, standard care practices, and medical norms

• Execute site start-up tasks, such as site qualification, coordinating the activation checklist, finalizing the Informed Consent Form (ICF), and conducting Site Initiation Visits (SIV) as necessary

• Organize training sessions and documentation essential for site activation

• Ensure follow-up after qualification and post-SIV to confirm site readiness

• Collaborate with Clinical Research Associates (CRAs) to guarantee monitoring preparedness and successful enrollment

• Establish and nurture connections with site organizations, strategic partners, investigators, and site personnel

• Manage communication and resolution of escalated site challenges, including vendor, contract, and payment matters

• Oversee strategies for investigational products and supplementary supplies throughout the study

• Strategize and execute site recruitment aligned with global, national, and local objectives

• Collaborate with regulatory bodies and study initiation teams on country/local registries

• Provide site recommendations and local insights based on performance metrics

• Assist study management with the import/export requirements of investigational products

• Review site reports and address related concerns

• Ensure quality and consistency in monitoring delivery

• Support CRA relationships with investigators and escalate any training or compliance issues

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

• Adhere to Parexel processes, ICH-GCP guidelines, and relevant regulations

⛳️ Requirements

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

• Proficient computer skills along with a willingness to adopt new technologies

• Strong communication, presentation, and interpersonal abilities

• Capability to manage necessary travel commitments

• Proven networking and relationship-building expertise

• Demonstrated ability to manage cross-functional relationships

• Effective communication skills with both internal and external stakeholders

• Adaptability to evolving technologies and processes

• Understanding of country-specific GCP regulations

• Proficiency in overcoming obstacles during the implementation of new processes and systems

• Ability to develop productive relationships with investigator site staff and stakeholders

• Strong verbal and written communication skills

• Competence in managing escalated site issues

• Proven experience in site management, with prior roles as a CRA

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

• Proven background in study conduct and close-out tasks

• Knowledge of quality and regulatory requirements in applicable regions

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

• Minimum of 5 years of experience is anticipated for the equivalent combination pathway

• Proficiency in English is mandatory

• Knowledge of the local language is preferred

🏝️ Benefits

• Equal opportunity employment

• Comprehensive training curriculum

• Travel reimbursement through expense reports (implied by required expense reporting)