Senior Clinical Research Associate

Medicines360

. Lead day-to-day clinical operations across the study lifecycle, including feasibility, start-up, conduct, monitoring, closeout, and archival .

Posted 10/22/2026full-timeSan Francisco • California • United StatesSenior💰 $116,000 - $125,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical operations throughout the study lifecycle, including site management, regulatory compliance, and data quality assurance. Proficient in coordinating with CROs and vendors while maintaining strong communication and organizational skills.

Highest-signal resume keywords

Clinical Research ExperienceSite ManagementGood Clinical PracticeRegulatory ComplianceProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementSite MonitoringData Quality AssuranceProtocol ComplianceRisk AssessmentFeasibility AssessmentBudget CoordinationEnrollment ProjectionsStudy DocumentationClinical SOP Development

Soft Skills

Analytical SkillsProblem-Solving SkillsOrganizational SkillsCommunication SkillsCollaboration Skills

Tools & Technologies

ETMFEDCCTMSMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookMicrosoft Teams

Certifications & Qualifications

ACRP CCRAACRP-CPSOCRA CCRP

Industry Keywords

Clinical OperationsInvestigational ProductMedical DevicesIVD DevicesWomen’s HealthInternational Study ExperienceEthics SubmissionsClinical Quality SystemsStudy LogisticsMulticenter Studies

About the role

Key responsibilities & impact

Lead day-to-day clinical operations across the study lifecycle, including feasibility, start-up, conduct, monitoring, closeout, and archival
Independently manage assigned studies, sub-studies, countries, regions, sites, or functional workstreams
Serve as primary contact for investigators and site staff; drive site activation, enrollment, and retention
Coordinate site clinical trial agreements, budgets, and payments
Plan, conduct, document, and follow up on site qualification, initiation, interim monitoring, remote monitoring, and closeout visits
Co-monitor with CRO CRAs and verify resolution of findings and action items
Assess site performance, protocol compliance, informed consent, participant safety, source documentation, product accountability, data quality, and regulatory file completeness
Coordinate CROs, laboratories, imaging and diagnostic vendors, technology providers, depots, and other service providers
Coordinate country- and site-level requirements, ethics and regulatory submissions, translations, import/export needs, and global study logistics
Provide input to feasibility, site selection, enrollment projections, timelines, and risk assessments
Draft, review, and maintain clinical documents and study materials
Maintain trial master files and investigator site files and support inspection readiness
Coordinate investigational product, device, IVD kit, specimen, and ancillary supply logistics
Support study-specific training and present at investigator and internal study meetings
Partner cross-functionally to resolve protocol, safety, data, product, and operational issues
Review enrollment, retention, monitoring metrics, data listings, queries, deviations, safety information, complaints, deficiencies, and study trends
Maintain study trackers and prepare status reports, enrollment reports, and monitoring dashboards
Support regulatory submissions, audits, inspections, responses, CAPAs, and commitments
Contribute to clinical SOPs, templates, tools, and process improvements
Provide mentoring, co-monitoring, quality review, and technical guidance to less experienced CRAs and study team members

Requirements

What you’ll need

Bachelor’s degree in life sciences, nursing, pharmacy, medicine, biomedical engineering, public health, or a related discipline
Advanced degree or equivalent combination of education and relevant experience preferred
Typically 5 or more years of progressively responsible clinical research experience
At least 3 years of independent site monitoring and site management experience
Experience as a lead CRA or study lead strongly preferred
Experience in women’s health highly desirable
Experience supporting or managing clinical studies of varied size and complexity, including multicenter studies
International study experience strongly preferred
Experience with drugs, medical devices, IVD devices, or combination products required
Strong working knowledge of Good Clinical Practice, FDA regulations, and ICH guidance
Knowledge of country, regional, ethics, device, IVD, privacy, and product-specific requirements
Working knowledge of clinical quality systems, essential document requirements, eTMF, EDC, CTMS, safety systems, and other study technologies
Ability to coordinate with CROs and vendors, manage competing priorities, interpret study metrics, anticipate risks, and drive issues to resolution
Excellent monitoring, documentation, analytical, organizational, problem-solving, and project-management skills
Clear written and verbal communication skills and ability to collaborate across functions, cultures, time zones, and external organizations
Ability to work independently in a small, mission-driven organization and contribute to a cross-functional team
Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams
Ability to travel domestically and internationally up to approximately 50%
Clinical research certification such as ACRP CCRA, ACRP-CP, or SOCRA CCRP is a plus
Must be able to remain stationary 50% of the time
Ability to communicate information accurately and observe details at close range

Benefits

Comp & perks

Hybrid work arrangement
Full-time, exempt position
Equal opportunity employment and nondiscrimination protections