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Clinical Research Coordinator II – Oncology
Syneos Health. Review assigned protocols and study documentation for accuracy, feasibility, timing, and resources .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with Good Clinical Practices, and coordinating multiple projects effectively. Proficient in data collection, regulatory documentation, and maintaining study integrity while supporting Principal Investigators.
Highest-signal resume keywords
Clinical Research CertificationGood Clinical Practices (GCP)Clinical Trial EDC SoftwareOncology ExperienceSOP Writing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data CollectionCase Report Forms (CRFs)Regulatory DocumentationQuality ControlAdverse Event ReportingStudy Protocol ComplianceParticipant ScreeningStudy Logistics CoordinationClinical Trial ManagementInvestigator Site File Management
Soft Skills
Problem SolvingTime ManagementAttention to DetailInterpersonal SkillsCommunication Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPoint
Certifications & Qualifications
Registered NurseBachelor of Science Degree
Industry Keywords
Clinical ResearchICH GuidelinesPrivacy RegulationsStudy Start-Up ActivitiesParticipant SafetyMonitoring PlansAudit FacilitationStudy Close-Out DocumentationTrial Master Files (TMF)Informed Consent Activities
About the role
Key responsibilities & impact- Review assigned protocols and study documentation for accuracy, feasibility, timing, and resources
- Prepare and maintain Investigator Site Files and/or Trial Master Files
- Participate in timelines, start-up meetings, and sponsor discussions
- Coordinate study start-up activities, clinic logistics, training, source documents, CRFs, laboratory workbooks, staffing, schedules, safety assessments, quality control, monitoring plans, pharmacy requirements, supplies, and regulatory documentation
- Support the Principal Investigator with delegation logs, daily tasks, visit calendars, monitor visits, and participant recruitment and screening
- Perform study activities according to Good Clinical Practices
- Manage multiple clinical trials simultaneously and protect participant safety
- Collect and enter study data, complete Case Report Forms, submit data, and facilitate audits
- Coordinate screening and informed consent activities
- Supervise clinic visits, provide on-call support, screen eligibility, and oversee or perform study drug administration as delegated
- Monitor study activities for compliance with protocol, SOPs, and applicable regulations
- Manage clinic updates, adverse event and serious adverse event reporting, study logs, trackers, quality control, and monitor findings
- Coordinate resolution of QC, monitor, CRF, and other findings
- Oversee study close-out documentation, deviations, CRF completion, TMF updates, logs, supplies return, IRB reports, and archiving
- Monitor participant compliance and escalate trial or study issues
- Prepare for and participate in sponsor, monitor, and QA audits
- Provide timely project status updates to Project Managers and sponsors
- Collaborate on process improvement, SOP creation/revision, meetings, and company initiatives
- Coordinate regulatory activities, including protocol, consent, amendment, and yearly renewal submissions
- Report trial-related adverse events and maintain study files
- Perform other assigned work-related duties
- Travel up to 100%
Requirements
What you’ll need- Registered Nurse and/or University Degree such as Bachelor of Science Degree required
- Clinical Research certification preferred
- Minimum of 1 year experience in clinical research required; 2+ years preferred
- Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines
- Problem solving, planning, and evaluation skills
- Good time management and attention to detail; ability to multitask
- Good interpersonal and communication skills with a team focus
- Knowledge of SOP writing
- Ability to anticipate problems and provide timely solutions
- Ability to coordinate multiple clinical research projects with competing deadlines
- Proficiency in Word, Excel, and PowerPoint
- Proficiency in clinical trial EDC software preferred
- Experience in Oncology
- Ability to travel up to 100%
- Equivalent experience, skills, and/or education may be considered
Benefits
Comp & perks- Permanent part-time employment
- Remote work (pre-approved)
- Flexible schedule, including days, afternoons, nights, and weekends
- Opportunity to work on clinical research projects across diverse therapeutic areas
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities