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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical site management and monitoring, ensuring compliance with ICH/GCP guidelines and maintaining high-quality standards throughout clinical trials. Proficient in managing site performance, patient recruitment, and regulatory documentation while effectively communicating with investigators and site staff.
Highest-signal resume keywords
Clinical Site ManagementMonitoring SkillsRegulatory DocumentationGCP/ICH CompliancePatient Recruitment
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical ResearchSite MonitoringData AnalysisGood Documentation PracticesRoot Cause Analysis
Soft Skills
Time ManagementOrganizational SkillsInterpersonal SkillsProblem-Solving SkillsConflict Management
Tools & Technologies
Clinical Trial Management SystemsElectronic Trial Master File SystemsMS OfficeClinical IT Applications
Industry Keywords
Clinical TrialsBio/PharmaCROSite PerformanceStudy Protocols
About the role
Key responsibilities & impact- Act as the primary site contact and site manager throughout all phases of clinical research studies
- Develop strong site relationships and ensure continuity throughout trial phases
- Perform clinical study site management and monitoring activities in compliance with ICH/GCP, SOPs, laws, regulations, protocol, and monitoring plans
- Gain an in-depth understanding of study protocols and related procedures
- Coordinate tasks with sponsor roles to achieve Site Ready
- Participate in site selection and validation activities
- Perform remote and on-site monitoring and oversight activities
- Ensure site data are complete, accurate, and unbiased
- Protect subjects' rights, safety, and well-being
- Conduct validation, initiation, monitoring, and closeout visits
- Prepare accurate visit and non-visit contact reports
- Collect, review, and monitor regulatory documentation
- Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, audits, inspections, and site performance
- Identify, assess, resolve, and escalate site performance, quality, and compliance issues
- Maintain information and documentation in clinical trial management and electronic trial master file systems
- Contribute to CRA team knowledge as a subject matter expert, buddy, or mentor
- Support or lead audits and inspection activities
- Perform co-monitoring visits
- Complete required training, timesheets, expense reports, and CV updates
- Maintain compliance with Parexel/client processes, ICH-GCP, and applicable requirements
Requirements
What you’ll need- Fluent in local languages and English (verbal and written)
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law and guidelines
- Good understanding of Global, Country/Regional Clinical Research Guidelines
- Hands-on knowledge of Good Documentation Practices
- Proven skills in site management, including management of site performance and patient recruitment
- Demonstrated high level of monitoring skill with independent professional judgement
- Good IT skills, including MS Office and clinical IT applications on computer, tablet and mobile devices
- Ability to understand and analyze data/metrics and act appropriately
- Ability to manage complex issues in a solution-oriented manner
- Root cause analysis and preventative/corrective action implementation
- Effective time management, organizational, interpersonal, conflict management, and problem-solving skills
- Ability to work independently across multiple protocols, sites, and therapy areas
- Ability to set priorities and handle multiple tasks simultaneously
- Ability to work effectively in a matrix multicultural environment
- High quality and compliance mindset
- Minimum 2 years of direct site monitoring experience in bio/pharma/CRO
- Bachelor's degree preferred with a strong emphasis in science and/or biology
Benefits
Comp & perks- Equal opportunity employer
- Remote work arrangement (United States)