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Senior Clinical Research Associate I (Ophthalmology & Oncology)

Syneos Health
Syneos Health
5-6 years
preferred by company
Gurgaon, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Clinical Trials, Functional Teams, Literature Review, Management Skills, Medical Information, Medical Records, Medical Strategy, Pharmacovigilance, Regulatory Compliance, Risk Management, Safety Scien, Coaching Skills, Data Science, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Pro, Collaboration, Communication Skills, gmp, GMP Guidelines, Operational Excellence, Problem Solving Skills, Quality Agreements, Quality Compliance, Quality Management, Quality Standards, Regulatory Requ, Communication Skills, Continual Improvement Process, Master Data, Material Requirements Planning (Mrp), Materials Management, People Management, Production Planning, Supplier Relationship Management (Srm), Supply-Chain Man, CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat

 

Job Title: Senior Clinical Research Associate I (Ophthalmology & Oncology)

Location: Gurgaon, Haryana, India
Job Type: Full-Time
Experience Required: 5–6 Years (Freshers are not eligible)
Industry: Clinical Research / CRO / Pharmaceuticals / Biotechnology / Oncology / Ophthalmology / Life Sciences
Department: Clinical Operations / Clinical Monitoring / Clinical Trial Management

About the Role
We are seeking an experienced and highly execution-focused Senior Clinical Research Associate I (Sr CRA I) with expertise in Ophthalmology and Oncology clinical trials to support end-to-end site monitoring, trial execution, regulatory compliance, and operational excellence across global clinical research programs. This role is ideal for professionals with strong expertise in clinical monitoring, site management, ICH-GCP compliance, oncology studies, ophthalmology trials, and clinical operations leadership.

The ideal candidate will lead monitoring activities across study sites, ensure protocol and regulatory compliance, support patient safety oversight, and contribute to successful delivery of high-quality clinical trial programs.

This opportunity is highly suited for experienced CRAs seeking career growth in advanced clinical operations and therapeutic area specialization.

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 close-out visits (COV)
  • Ensure study execution aligns with protocol requirements, sponsor expectations, regulatory standards, and operational timelines.
  • Evaluate overall site performance and recommend corrective actions where needed.
  • Escalate critical operational or compliance issues promptly to project teams.

Regulatory Compliance & GCP Oversight

  • Ensure compliance with ICH-GCP, local regulatory requirements, Good Pharmacoepidemiology Practice (GPP), sponsor SOPs, and protocol-specific procedures.
  • Verify proper informed consent documentation and subject confidentiality protections.
  • Identify protocol deviations, compliance risks, patient safety concerns, and data integrity issues proactively.
  • Support audit readiness, inspection preparedness, and corrective follow-up actions.

Source Data Verification & Data Quality Management

  • Conduct Source Document Review (SDR) and Source Data Verification (SDV) to ensure clinical data accuracy, completeness, and consistency.
  • Verify data entered into Case Report Forms (CRFs) and electronic data capture systems.
  • Manage and drive timely query resolution with investigative sites.
  • Ensure adherence to electronic data capture and clinical database compliance requirements.

Investigational Product (IP) Management

  • Review investigational product accountability, inventory, reconciliation, storage, security, and dispensing practices.
  • Ensure investigational products are handled according to protocol, blinding/randomization procedures, and regulatory standards.
  • Verify IP import, labeling, release, and return compliance where applicable.

Trial Documentation & TMF / ISF Management

  • Review and maintain Investigator Site Files (ISF) for completeness, timeliness, and accuracy.
  • Reconcile ISF documentation with Trial Master File (TMF) requirements.
  • Ensure archival readiness and compliance with essential document management standards.
  • Prepare and maintain:
    • Monitoring visit reports
    • Follow-up letters
    • Communication logs
    • Action tracking records
    • Study documentation packages

Patient Recruitment & Site Engagement

  • Support patient recruitment, retention, awareness strategies, and operational site performance improvement initiatives.
  • Collaborate with site teams to optimize recruitment efficiency and protocol adherence.
  • Maintain strong working relationships with investigators, coordinators, and clinical site personnel.

Stakeholder Management & Cross-Functional Collaboration

  • Serve as a key liaison between study sites, project teams, sponsors, and internal clinical stakeholders.
  • Participate in investigator meetings, sponsor governance meetings, project discussions, and monitoring team calls.
  • Collaborate with central monitoring teams, regulatory teams, and operational leadership.

Mentorship & Clinical Leadership

  • Provide mentorship, training, and operational guidance to junior CRA team members where applicable.
  • Support training visits, performance development, and monitoring quality improvement initiatives.
  • May support Clinical Operations Lead (COL) responsibilities under supervision.

Therapeutic Area Expertise

  • Apply strong therapeutic knowledge in:
    • Oncology clinical trials
    • Ophthalmology clinical studies
  • Support protocol interpretation, site education, and operational issue resolution specific to assigned therapeutic programs.

Required Qualifications

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Clinical Research, Biotechnology, Biomedical Sciences, or related disciplines OR Registered Nurse equivalent.
  • Minimum 5–6 years of clinical research experience.
  • Mandatory 5+ years of clinical monitoring/site monitoring experience.
  • Strong therapeutic expertise in Oncology and Ophthalmology.
  • Deep understanding of ICH-GCP, clinical trial monitoring, regulatory compliance, TMF/ISF management, and patient safety oversight.
  • Experience with EDC systems, CRFs, query management, site performance oversight, and sponsor-facing trial execution.
  • Strong communication, presentation, stakeholder management, and critical thinking skills.
  • Ability to adapt to dynamic global clinical trial environments.
  • Willingness to travel extensively (up to 75% travel required