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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: Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs

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 an experienced and highly motivated CRA II / Senior CRA I (Oncology) to support global oncology clinical trials through advanced site monitoring, regulatory oversight, patient safety management, and end-to-end clinical trial execution. This role is ideal for professionals with deep expertise in clinical monitoring, oncology research, site management, ICH-GCP compliance, investigational product oversight, and audit readiness.

The ideal candidate will lead monitoring activities across assigned oncology studies, ensure protocol adherence, maintain clinical data integrity, and build strong relationships with investigative sites, sponsors, and cross-functional clinical teams.

This role is highly suited for experienced oncology CRAs looking to advance their careers in global clinical operations.

Key Responsibilities

Clinical Monitoring & Site Management

  • Perform comprehensive site monitoring activities across the full clinical trial lifecycle, including:
    • Site Qualification Visits (SQV)
    • Site Initiation Visits (SIV)
    • Interim Monitoring Visits (IMV)
    • Remote monitoring support
    • Site management oversight
    • Site Close-Out Visits (COV)
  • Ensure study execution aligns with protocol requirements, sponsor expectations, timelines, and regulatory standards.
  • Evaluate site performance, identify risks, recommend corrective actions, and escalate critical issues proactively.
  • Support smooth execution of monitoring plans and site management strategies.

Oncology Clinical Trial Execution

  • Apply strong expertise in Oncology clinical research to support complex study execution and site oversight.
  • Manage oncology-specific clinical trial requirements, patient eligibility considerations, treatment workflows, and study compliance needs.
  • Support advanced therapeutic area discussions with site investigators and oncology stakeholders.

Regulatory Compliance & Patient Safety 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 informed consent documentation accuracy and ethical study conduct at all assigned sites.
  • Protect patient confidentiality, rights, and safety throughout study execution.
  • Identify protocol deviations, pharmacovigilance concerns, safety risks, and compliance gaps proactively.

Source Data Verification & Clinical Data Integrity

  • Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure accuracy, completeness, and reliability of study data.
  • Verify data entered into Case Report Forms (CRFs) and electronic clinical systems.
  • Drive timely query management and resolution with site personnel.
  • Ensure site compliance with electronic data capture requirements and study documentation standards.

Investigational Product (IP) Oversight

  • Review investigational product accountability, reconciliation, dispensing, storage, and security practices.
  • Ensure IP handling aligns with protocol requirements, blinding/randomization processes, and regulatory expectations.
  • Verify labeling, import/release processes, and product return compliance where applicable.

TMF / ISF Documentation & Audit Readiness

  • Review Investigator Site Files (ISF) for completeness, timeliness, and regulatory compliance.
  • Reconcile site documentation with Trial Master File (TMF) expectations.
  • Ensure essential documents are maintained appropriately and archived according to applicable regulations.
  • Maintain monitoring documentation including trip reports, follow-up letters, communication logs, and issue trackers.

Site Engagement, Recruitment & Relationship Management

  • Act as a key liaison between study sites, sponsors, and internal project teams.
  • Support patient recruitment, retention strategies, site awareness initiatives, and operational performance improvement.
  • Build strong relationships with investigators, study coordinators, physicians, and site personnel.
  • Ensure assigned sites and study teams remain trained and compliant throughout study conduct.

Meetings, Training & Cross-Functional Collaboration

  • Participate in investigator meetings, sponsor governance sessions, global project calls, and clinical training programs.
  • Collaborate with Central Monitoring Associates, Medical Science Liaisons (MSLs), sponsor affiliates, and country stakeholders.
  • Support training and mentoring of junior CRA staff where required.

Project Delivery & Operational Execution

  • Manage site-level deliverables within defined timelines, project scope, and operational expectations.
  • Adapt quickly to shifting priorities, study complexities, and changing business requirements.
  • Identify out-of-scope activities and communicate them to project leadership appropriately.
  • Contribute local site intelligence based on treatment patterns, patient advocacy networks, and healthcare provider ecosystems.

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, site monitoring, regulatory compliance, patient safety, pharmacovigilance awareness, and clinical documentation standards.
  • Experience with EDC systems, CRFs, SDV/SDR, TMF/ISF management, and sponsor-facing clinical operations.
  • Strong computer proficiency and adaptability to clinical technologies.
  • Excellent communication, presentation, interpersonal, and stakeholder management skills.
  • Ability to travel extensively (up to 75% travel required).