Sr Cra I (Oncology/Ophthalmology)

Syneos Health

3-6 years

Not Disclosed

India

10 Nov. 28, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Research Associate I (Oncology / Ophthalmology) – Remote, India

Location: Remote (India)
Job ID: 25102625
Updated: November 5, 2025
Experience Required: 3–6 years in clinical monitoring, preferably in Oncology or Ophthalmology studies

About Syneos Health

Syneos Health® is a global, fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We transform clinical, medical affairs, and commercial insights into actionable outcomes that meet modern healthcare challenges.

Our Clinical Development model prioritizes both patient safety and client objectives. By simplifying processes and fostering innovation, Syneos Health creates an environment where professionals can thrive while delivering therapies that change lives globally.

Role Overview

The Senior Clinical Research Associate I (CRA I) will monitor clinical trial sites across Oncology and Ophthalmology studies, ensuring adherence to ICH-GCP, regulatory, and protocol standards. This role involves remote and on-site monitoring, oversight of site performance, and management of investigational product and patient safety processes. The CRA I will also support site start-up, regulatory compliance, and data integrity across all assigned studies.

Key Responsibilities

Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) in compliance with ICH-GCP, protocol, and local regulations.
Review informed consent processes, ensuring patient confidentiality and safety.
Monitor site performance, identify risks, and escalate serious issues with actionable recommendations.
Perform source document verification to ensure accuracy and completeness of Case Report Forms (CRFs).
Manage query resolution, provide guidance to site staff, and ensure timely closure of queries.
Oversee investigational product (IP) handling, including inventory, storage, dispensation, and compliance with protocol-specific requirements.
Maintain and reconcile Investigator Site Files (ISF) with the Trial Master File (TMF), ensuring completeness and audit readiness.
Support patient recruitment, retention, and engagement strategies.
Track site activities, observations, and action items using project tracking tools.
Participate in Investigator Meetings, sponsor meetings, and clinical training sessions as required.
Mentor and provide guidance to junior CRAs, including training and sign-off visits.
Support Real-World Late Phase (RWLP) studies with site selection, chart abstraction, and collaboration with sponsors, regulatory teams, and local affiliates.
Proactively suggest potential sites based on local treatment patterns, patient advocacy, and HCP networks.
Identify operational efficiencies and recommend process improvements for clinical site management.

Required Qualifications & Experience

Bachelor’s degree or RN in Life Sciences, Nursing, Pharmacy, or related field.
3–6 years of experience as a Clinical Research Associate in Oncology, Ophthalmology, or related therapeutic areas.
Strong knowledge of GCP/ICH guidelines, local regulatory requirements, and clinical trial processes.
Proven skills in remote and on-site site monitoring, source document verification, and IP management.
Excellent communication, interpersonal, and problem-solving skills.
Ability to manage travel up to 75% for on-site monitoring.
Proficiency with clinical trial management tools, EDC systems, and electronic monitoring technologies.

Why Syneos Health?

Work with a global team of 29,000 employees across 110 countries.
Contribute to clinical trials impacting 94% of novel FDA-approved drugs and 95% of EMA-authorized products over the past five years.
Opportunities for professional development, mentorship, and career progression.
Inclusive, collaborative, and supportive workplace culture that values diversity, innovation, and recognition.

Additional Information

Responsibilities listed are not exhaustive. Syneos Health may assign additional duties based on project requirements. Equivalent experience and qualifications may be considered. The company complies with all applicable global employment regulations, including ADA provisions and local legislation.

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Sr Cra I (Oncology/Ophthalmology)

Job Description

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