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Senior Clinical Research Associate
SiteroSenior Clinical Research Associate managing clinical trials for clinical services and software solutions in life sciences industry. Primary contact for site personnel and oversight of trial activities in Warsaw, Poland.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including site qualification, monitoring, and compliance with ICH-GCP standards. Proficient in regulatory submissions and documentation, with a strong focus on data integrity and patient safety.
Highest-signal resume keywords
Clinical Research ExperienceSite Management ExperienceKnowledge of GCPRegulatory RequirementsOncology Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial OperationsSite QualificationSite InitiationMonitoring Visit ReportsData Integrity ManagementProtocol Deviation IdentificationPharmacovigilanceEssential Document CollectionCentral MonitoringRegulatory Applications
Soft Skills
CommunicationPresentation SkillsCollaboration
Tools & Technologies
CTMSVendor Dashboards
Industry Keywords
Life SciencesNursingPharmacyClinical TrialsICH-GCPOncology
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Primary point of contact for site personnel during life cycle of clinical trial
- Provides support to the Global Project Lead and CTM during project start up to ensure timely site selection and feasibility
- Assists with collection of essential documents from the site
- May assist with submission of central EC Applications, Local EC applications, RA applications and any other local regulatory applications/Approvals required
- Ability to identify protocol deviations and pharmacovigilance issues that might affect data accuracy or patient safety
- Conduct Site qualification, site initiation, routine site monitoring close out visits (remote and onsite), Central monitoring in compliance with study protocol and ICH-GCP
- Expert documentation of monitoring priorities/activities via site visit confirmation and follow up letters, monitoring visit reports, and any trial associated logs
- Oversees conduct trials by reviewing study data listings, vendor dashboards, and CTMS issues/actions documentation to identify trends, errors, and any potential breeches that can impact data integrity
- Ability to present essential function of CRA role in Bid Defenses, Investigator Meetings, and Sponsor Face to Face meetings
- Assists the Global Project Lead in identification of out-of-scope activities
- Basic understanding of assigned projects scope, milestones and budget and manages site level activities to ensure project deliverables are met
Requirements
What you’ll need- Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field required; advanced degree (MS, MPH, PharmD, or PhD) preferred
- Minimum of 5-10 years of clinical research experience
- Demonstrated site management experience
- Strong knowledge of GCP, regulatory requirements, and clinical trial operations
- Oncology experience preferred
Benefits
Comp & perks- competitive salary
- paid time off
- healthcare benefits
- retirement benefits