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Senior Clinical Research Associate
Lifelancer. Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in conducting clinical trial site management, including site qualification, monitoring, and compliance. Proficient in mentoring staff and ensuring adherence to protocols while maintaining high standards of documentation and communication.
Highest-signal resume keywords
Clinical Trial Site ManagementSite QualificationMicrosoft Office ProficiencyCTMS ExperienceEDC Systems Knowledge
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 MonitoringSource Document VerificationData Query ResolutionProtocol Adherence AssessmentClinical Research Associate Experience
Soft Skills
Interpersonal CommunicationOrganizational SkillsAttention to DetailAbility to Work Independently
Certifications & Qualifications
4-Year University DegreeRN/BSN in Nursing
Industry Keywords
Trial Master FileInformed ConsentPatient SafetyInvestigational Product ComplianceClinical Research
About the role
Key responsibilities & impact- Conduct site qualification, initiation, interim monitoring, site management, and study close-out visits
- Mentor and guide less experienced CRAs and site staff
- Document site visit findings via written reports
- Assess, monitor, and train study site staff on protocol adherence
- Review study subject safety information and informed consent
- Conduct source document verification for compliance, patient safety, and data veracity
- Review CRFs using paper or electronic data capture systems
- Assist sites with data query resolution
- Provide updates for site-related documentation for filing in the Trial Master File
- Ensure site compliance with investigational product receipt, accountability, and return or destruction
- Conduct accompanied site visits for assessment or training of other CRAs
Requirements
What you’ll need- Excellent interpersonal, oral, and written communication skills in English
- Superior organizational skills with attention to detail
- Ability to work with little or no supervision
- Proficiency in Microsoft Office, CTMS, and EDC systems
- 5+ years of experience as a Clinical Research Associate
- 4-year university degree or RN/BSN in Nursing
- Willingness to travel
- Ability to conduct clinical trial site qualification, initiation, interim monitoring, site management, and study close-out visits
Benefits
Comp & perks- Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law
- Supportive and cohesive teams
- Diverse and inclusive work environment
- Remote work arrangement