CRA II / Sr. CRA I (Oncology) – Structured Job Format
Job Overview
Position: CRA II / Sr. CRA I (Oncology)
Company: Syneos Health
Location: IND-Client
Job ID: 25108468
Updated: Today
Department: Clinical Monitoring / Clinical Operations
About the Company
Syneos Health is a fully integrated life sciences services organization focused on accelerating customer success across the drug development and commercialization lifecycle.
The company supports:
94% of novel FDA-approved drugs (past 5 years)
95% of EMA-authorized products
200+ studies across 73,000 sites globally
Role Summary
The CRA II / Sr. CRA I (Oncology) is responsible for:
Monitoring clinical trial sites
Ensuring compliance with ICH-GCP and regulatory requirements
Supporting oncology clinical studies
Managing site activities throughout the study lifecycle
Ensuring subject safety and data integrity
This role involves both onsite and remote monitoring activities and requires extensive collaboration with study sites, sponsors, and project teams.
Key Responsibilities
Clinical Site Monitoring
Conduct:
Site Qualification Visits (SQV)
Site Initiation Visits (SIV)
Interim Monitoring Visits
Close-Out Visits
Perform onsite and remote monitoring activities
Ensure protocol compliance and regulatory adherence
Compliance & Regulatory Oversight
Ensure compliance with:
ICH-GCP Guidelines
Local regulatory requirements
Company SOPs
Verify informed consent documentation
Identify and escalate protocol deviations and safety concerns
Data Review & Source Verification
Conduct Source Data Verification (SDV)
Review:
Medical records
Source documents
CRFs/eCRFs
Resolve data queries within timelines
Ensure electronic data capture compliance
Investigational Product (IP) Management
Review IP storage and accountability
Verify dispensing and administration compliance
Ensure proper labeling, reconciliation, and return processes
Documentation & Reporting
Maintain:
Investigator Site File (ISF)
Trial Master File (TMF)
Prepare:
Trip reports
Follow-up letters
Monitoring reports
Communication logs
Site & Project Management
Support:
Patient recruitment and retention
Site staff training
Audit readiness activities
Coordinate with:
Sponsor teams
Study coordinators
Clinical project teams
Additional Responsibilities
Attend investigator meetings and sponsor meetings
Participate in clinical training sessions
Mentor/train junior staff when required
Recommend potential sites based on local treatment knowledge
Required Qualifications
Education
Bachelor’s degree in a related field
OR
Registered Nurse (RN) qualification
OR
Equivalent combination of education and experience
Required Experience & Skills
Experience
Minimum 5+ years of clinical monitoring experience
Strong oncology monitoring experience (mandatory)
Technical Knowledge
Good Clinical Practice (GCP)
ICH Guidelines
Regulatory compliance
Clinical trial processes
Skills
Strong communication skills
Presentation and interpersonal skills
Computer proficiency
Ability to adapt to new technologies
Time and priority management
Travel Requirements
Up to 75% travel required on a regular basis
Preferred Competencies
Risk-based monitoring experience
Site management expertise
Audit readiness preparation
Strong problem-solving skills
Ability to manage changing priorities
Work Environment & Culture
Why Join Syneos Health?
Career development and progression
Supportive leadership and mentorship
Technical and therapeutic-area training
Inclusive and diverse workplace culture
Global collaboration opportunities
Competitive rewards and recognition programs
Functional Areas Covered
Clinical Monitoring
Site Management
Oncology Trials
Data Integrity
Patient Safety
Regulatory Compliance
Ideal Candidate Profile
The ideal candidate should:
Have strong oncology CRA experience
Be confident managing multiple sites independently
Understand regulatory expectations deeply
Be comfortable with extensive travel
Demonstrate excellent stakeholder communication skills
Thrive in fast-paced clinical environments
Employment Notes
Additional responsibilities may be assigned as needed
Equivalent qualifications and experience may be considered
Syneos Health is an equal opportunity employer
Reasonable accommodations are available where appropriate
Application
Apply via:
Syneos Health Careers
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