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Senior Clinical Research Associate
Humaneva Group. Perform monitoring and site management activities for Phase I-IV clinical research projects at assigned investigative/physician sites .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research project management, particularly in oncology trials, ensuring compliance with regulatory standards and Good Clinical Practice. Proficient in site evaluation, monitoring, and data integrity assessment while effectively supporting patient recruitment and retention strategies.
Highest-signal resume keywords
Oncology Trial Monitoring ExperienceClinical Research Experience in CROKnowledge of Good Clinical Practice/ICH GuidelinesBachelor’s Degree in Life Sciences or EquivalentProficient Computer Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Site Management ActivitiesSite EvaluationInterim MonitoringSource Document ReviewData Tracking SystemsInvestigational Product AccountabilityProtocol CompliancePatient Safety AssessmentClinical Data IntegrityQuery Resolution Techniques
Soft Skills
Strong Communication SkillsLiaison AbilitiesProblem-Solving SkillsTeam Collaboration
Tools & Technologies
Tracking SystemsAnalytical DashboardsTrial Master File
Industry Keywords
Clinical ResearchPharmaceuticalBiotechnologyMedical DevicePhase I-IV Clinical TrialsRegulatory CompliancePharmacovigilanceSite ActivationPatient Recruitment StrategiesClinical R&D
About the role
Key responsibilities & impact- Perform monitoring and site management activities for Phase I-IV clinical research projects at assigned investigative/physician sites
- Serve as the primary liaison for project site personnel throughout the study lifecycle, from site identification through close-out
- Support site identification and site start-up
- Perform site evaluation, site initiation, interim monitoring, and close-out assessments on-site or remotely
- Perform telephone assessments and central monitoring remotely
- Ensure regulatory, ICH-GCP, and protocol compliance
- Verify informed consent processes are adequately performed and documented
- Assess patient safety and clinical data integrity risks, including protocol deviations and pharmacovigilance issues
- Assess site processes and facilities and conduct Source Document Review and Source Document Verification
- Apply query resolution techniques, perform investigational product accountability, and review the Investigator Site File and Trial Master File reconciliation
- Support subject/patient recruitment, retention, and awareness strategies
- Enter data into tracking systems and track observations, status, and action items through resolution
- Review study and site data listings, visualizations, analytical dashboards, and reports to identify trends, risks, suspected scientific misconduct, and systematic errors
- Collect essential documents and compile document packages for site activation
Requirements
What you’ll need- Bachelor’s Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or equivalent combination of education and experience
- Minimum of 5 years of experience in clinical R&D in pharmaceutical, biotechnology and/or clinical research organization (CRO) businesses
- At least 2 years of experience in a CRO providing clinical research services to pharmaceutical, biotechnology or medical device companies
- Oncology trial monitoring experience required
- Demonstrated knowledge of oncology therapeutic area and early phase research design
- Demonstrated proficient computer skills and ability to embrace new technologies
- Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
- Ability to travel domestically and meet with sites within their institutions
Benefits
Comp & perks- Employee position
- Remote work arrangement
- On-site or remote monitoring activities
- Domestic travel opportunities/requirements