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Cra Ii / Senior Cra I (Oncology)

Syneos Health
Syneos Health
5+ years
preferred by company
PAN-India, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes

Job Title: CRA II / Senior CRA I (Oncology)

Location: India (Client-Based / Field Role)
Job Type: Full-Time
Experience Required: 5+ Years (Freshers are not eligible)
Industry: Clinical Research / CRO / Oncology Clinical Trials / Pharmaceuticals / Biotechnology / Life Sciences
Department: Clinical Operations / Clinical Monitoring / Site Management

About the Role
We are seeking a highly experienced and performance-driven CRA II / Senior CRA I (Oncology) to support global oncology clinical trials through advanced site monitoring, clinical trial execution, regulatory compliance, and investigator site management. This role is ideal for professionals with strong expertise in oncology clinical monitoring, site management, ICH-GCP compliance, clinical trial operations, investigational product oversight, and audit readiness.

The ideal candidate will lead end-to-end monitoring activities across assigned oncology studies, ensure protocol compliance, safeguard patient safety, and maintain high-quality clinical data integrity while collaborating with sponsors, investigators, and cross-functional clinical teams.

This opportunity is highly suited for experienced oncology CRAs seeking advanced growth in global clinical operations.

Key Responsibilities

Clinical Site Monitoring & Trial Execution

  • Perform end-to-end clinical monitoring activities including:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • Interim Monitoring Visits (IMV)
    • Remote monitoring activities
    • Site management oversight
    • Site Close-Out Visits (COV)
  • Ensure study conduct aligns with protocol requirements, sponsor expectations, regulatory requirements, and operational timelines.
  • Evaluate overall site performance, identify risks, and implement corrective action plans where required.
  • Escalate serious compliance or operational issues to project teams proactively.

Oncology Clinical Trial Expertise

  • Apply deep therapeutic expertise in Oncology clinical research to support protocol execution, investigator engagement, patient safety oversight, and study quality management.
  • Support oncology-specific trial complexities including treatment protocols, patient eligibility, safety monitoring, and clinical data review.
  • Leverage local knowledge of treatment patterns, oncology investigators, and healthcare provider ecosystems where applicable.

Regulatory Compliance & GCP Oversight

  • Ensure compliance with:
    • ICH-GCP guidelines
    • Good Pharmacoepidemiology Practice (GPP) where applicable
    • Local regulatory requirements
    • Sponsor SOPs
    • Clinical Monitoring Plans / Site Management Plans
  • Verify proper informed consent execution and documentation for all enrolled patients.
  • Ensure patient confidentiality, safety protections, and ethical study conduct standards are maintained.
  • Identify protocol deviations, violations, pharmacovigilance concerns, and data integrity risks proactively.

Source Data Verification & Clinical Data Quality Management

  • Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure clinical data accuracy and completeness.
  • Verify Case Report Form (CRF) data against source documentation.
  • Drive timely query resolution with site teams and support accurate electronic data capture compliance.
  • Utilize clinical systems and digital tools effectively for remote and on-site monitoring activities.

Investigational Product (IP) Management

  • Review investigational product accountability, reconciliation, storage conditions, dispensing practices, and security controls.
  • Ensure IP handling complies with protocol requirements, blinding/randomization processes, and applicable regulations.
  • Verify appropriate labeling, import/export compliance, release procedures, and return management where applicable.

TMF / ISF Documentation & Audit Readiness

  • Review and maintain Investigator Site Files (ISF) for completeness, accuracy, and compliance.
  • Reconcile site documentation with Trial Master File (TMF) expectations.
  • Ensure archival readiness and compliance with essential document retention requirements.
  • Maintain project documentation including:
    • Trip reports
    • Follow-up letters
    • Communication logs
    • Monitoring documentation
    • Tracking systems and action logs

Site Relationship Management & Recruitment Support

  • Serve as a key liaison between sponsor teams and investigative sites.
  • Build strong relationships with investigators, study coordinators, physicians, and site personnel.
  • Support patient recruitment, retention, awareness initiatives, and site performance optimization strategies.
  • Ensure site staff training compliance and operational readiness throughout the study lifecycle.

Meetings, Training & Cross-Functional Collaboration

  • Attend investigator meetings, sponsor governance meetings, project reviews, and clinical training sessions.
  • Collaborate with central monitoring teams, medical science liaisons, sponsor affiliates, and local country stakeholders.
  • Support junior CRA training and mentoring where required.

Operational Delivery & Project Management Support

  • Manage assigned site-level deliverables within project scope, timelines, and budget expectations.
  • Adapt quickly to changing study priorities, operational challenges, and evolving project demands.
  • Identify and communicate out-of-scope activities to project leadership where applicable.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Clinical Research, Biotechnology, Biomedical Sciences, or related disciplines, OR Registered Nurse equivalent.
  • Minimum 5+ years of clinical monitoring experience.
  • Mandatory strong oncology clinical trial experience.
  • Deep knowledge of ICH-GCP, clinical monitoring practices, site management, regulatory compliance, pharmacovigilance awareness, and audit readiness standards.
  • Experience with EDC systems, CRF verification, source documentation review, TMF/ISF compliance, and sponsor-facing monitoring activities.
  • Strong communication, presentation, interpersonal, and stakeholder management skills.
  • Proficiency with clinical systems and modern monitoring technologies.
  • Ability to travel extensively (up to 75% travel required).