Site Care Partner

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

📋 Description

• Qualify and activate designated clinical trial sites

• Assist in country and site selection, which includes reviewing site lists, assessing protocol feasibility, and conducting outreach surveys

• Execute site start-up tasks, including site qualification, completing activation checklists, finalizing informed consent, and conducting Site Initiation Visits

• Organize training and necessary documentation for site activation

• Conduct follow-up after qualification and post-SIV to ensure sites are prepared for the First Subject First Visit

• Collaborate with Clinical Research Associates to guarantee monitoring readiness and successful enrollment

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

• Facilitate the resolution of escalated site delivery challenges, including vendor, contracts, and payment issues

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

• Work with regulatory authorities and study start-up teams to fulfill country and local registry obligations

• Provide recommendations and insights regarding sites, processes, and performance metrics at the country and regional levels

• Assist with import/export requirements for investigational products and ancillary supplies

• Review site reports and associated issues to support monitoring quality and consistency

• Foster positive relationships with investigators and escalate any training or compliance issues

• Adhere to Parexel's training protocols, timesheet submissions, expense reporting, CV updates, processes, ICH-GCP guidelines, and relevant regulatory requirements

⛳️ Requirements

• Oncology study experience is essential

• Experience in additional therapeutic areas is advantageous

• Familiarity with Good Clinical Practice, ICH Guidelines, and relevant regulatory requirements is necessary

• Proficient computer skills with a willingness to adapt to new technologies

• Strong communication, presentation, and interpersonal skills

• Capability to manage travel requirements

• Skills in networking and relationship building

• Ability to manage cross-functional relationships effectively

• Proficient in communicating with both internal and external stakeholders

• Adaptability to evolving technologies and processes

• Knowledge of country-specific GCP standards

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

• Aptitude for developing effective relationships with investigator site personnel and stakeholders

• Capacity to handle escalated site issues while addressing the needs of clients and site staff

• Proven site management experience, including prior work as a CRA

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

• Proven experience in study conduct and close-out procedures

• Comprehensive 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

• Minimum of 5 years of experience if utilizing the equivalent combination pathway

• Proficiency in English is required

• Proficiency in the local language is preferred

🏝️ Benefits

• Competitive salary and comprehensive benefits package

• Opportunities for professional growth and advancement

• Collaborative and inclusive work environment

• Flexible work arrangements