Site Care Partner
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Job Description
Site Care Partner managing US investigative sites for Parexel’s clinical trial services. Supporting site activation, recruitment, quality, regulatory compliance, and study close-out.
Responsibilities:
- Serve as a crucial liaison for investigative sites throughout the study lifecycle
- Qualify and activate assigned sites and deploy client site strategies
- Support country and site selection, feasibility strategy, analytics, and protocol feasibility activities
- Provide country/regional input to strategy, feasibility, protocol design, and outreach surveys
- Conduct site start-up activities, including site qualification, activation checklist coordination, ICF finalization, and SIVs as applicable
- Manage issues that may compromise time to site activation and ensure site readiness for FSFV
- Partner with CRAs to ensure monitoring readiness and enrollment delivery
- Build and maintain investigator site, site organization, and strategic partner relationships
- Coordinate resolution of escalated site issues, including vendor, contract, and payment issues
- Manage investigational product and ancillary supply strategies throughout the study lifecycle
- Partner with regulatory authorities and study start-up teams on country/local registry completion
- Gather country/region intelligence and provide site recommendations and site performance insights
- Support import/export requirement definition for investigational products and ancillary supplies
- Review site reports and related issues during study conduct
- Review and update SMO assessments and continuity/contingency plans
- Support decentralized capabilities, issue resolution, and client pipeline opportunities at investigator sites
- Act as a subject matter expert on client systems and processes when needed
- Develop efficiencies and best practices to improve site performance and investigator/site satisfaction
- Maintain clear communication with study teams and support CRA-investigator relationships
- Complete required training, timesheets, expense reports, CV updates, and comply with Parexel processes, ICH-GCPs, and applicable requirements
Requirements:
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Good computer skills and ability to embrace new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel
- Networking and relationship-building skills
- Ability to manage cross-functional relationships
- Ability to communicate effectively with internal and external stakeholders
- Ability to adapt to changing technologies and processes
- Knowledge of country-specific GCP requirements
- Experience overcoming barriers during implementation of new processes and systems
- 5+ years of prior experience as a CRA in a clinical research or pharma organization
- Experience reviewing monitoring reports
- Experience in start-up activities through site activation
- Experience in conduct and close-out activities
- Knowledge of quality and regulatory requirements in applicable countries
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience
- At least 5 years’ experience when qualifying through equivalent education, training and experience
- English is required
- Proficiency in local language preferred
- Oncology monitoring/CRA experience preferred
Benefits:
- Equal opportunity employer
- Required training curriculum
- Expense reimbursement through required expense reports
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