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Clinical Research Associate, Cardiovascular
MSDClinical Research Associate managing cardiovascular clinical trial sites and ensuring compliance with regulatory standards. Responsible for monitoring, site management, and collaboration with investigators.
Posted 7/9/2026full-timeRemote • Florida, New Jersey • 🇺🇸 United StatesJuniorMid-Level💰 $96,200 - $151,400 per yearWebsite
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure:
- Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with CRA-Manager, CRM, TA Head and CRD as needed.
- Works in partnership with GCTO country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
Requirements
What you’ll need- 5+ years of relevant experience in the healthcare field
- 2+ years of direct site management (monitoring) experience in a bio / pharma / CRO
- Associate's degree, certificate or equivalent in a scientific / healthcare discipline OR Bachelor's degree (or above)
- Fluent in Spanish and English (verbal and written)
- Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines
- Hands on knowledge of Good Documentation Practices
- Proven skills in Site Management including management of site performance and patient recruitment
- Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices)
- Ability to understand and analyze data/metrics and act appropriately
- Capable of managing complex issues, works in a solution-oriented manner
Benefits
Comp & perks- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Clinical Research KnowledgeSite Monitoring ActivitiesData AnalysisRegulatory Documentation ManagementPatient Recruitment Strategies
Soft Skills
Solution-Oriented Problem SolvingStrong Communication SkillsCollaboration with Cross-Functional Teams
Certifications
Associate's Degree in Scientific DisciplineBachelor's Degree in Healthcare Discipline