Senior Clinical Research Associate I (Ophthalmology) – Pune | Syneos Health
Job Summary:
Syneos Health is seeking a Senior Clinical Research Associate I (Sr CRA I) with a minimum of 4 years of on-site monitoring experience and specialized knowledge in ophthalmology clinical trials. Based in Pune, this role involves site qualification, initiation, monitoring, and close-out visits to ensure full regulatory and GCP compliance. Ideal for professionals looking to lead and manage diverse global clinical studies in a high-impact environment.
Key Responsibilities:
Conduct on-site and remote monitoring (initiation, interim, and close-out) per ICH-GCP and regulatory standards
Evaluate site performance, escalate critical issues, and develop action plans
Ensure informed consent process is adequately documented and compliant
Perform source document verification and query resolution to ensure CRF data integrity
Manage investigational product (IP) inventory and compliance per protocol
Reconcile site documentation with Trial Master File (TMF)
Support recruitment strategies, regulatory document review, and ISF/archiving requirements
Document monitoring activities in line with SOPs and protocols
Mentor junior CRAs and support audit readiness at assigned sites
Participate in investigator meetings, training sessions, and bid defense meetings
Collaborate with RWLP team on informed consent forms and regulatory submissions
Required Skills & Qualifications:
Bachelor’s degree in life sciences or nursing (RN) or equivalent experience
Minimum 4 years of on-site monitoring experience required
Must have ophthalmology therapeutic area experience
Strong understanding of ICH-GCP, clinical trial regulations, and CRA procedures
Familiar with CRFs, ISF, TMF, and pharmacovigilance
Excellent communication, interpersonal, and analytical skills
Willingness to travel up to 75% regularly
Proficiency in digital tools and remote monitoring technologies
Perks & Benefits:
Work in a global, multicultural clinical environment with top pharma sponsors
Access to structured CRA training programs and therapeutic area mentoring
Career development with opportunities to take on lead CRA or project roles
Peer recognition, rewards programs, and total well-being initiatives
Be part of a company known for developing 94% of all FDA-approved drugs in the last 5 years
Company Description:
Syneos Health is a leading, fully integrated biopharmaceutical solutions company with 29,000+ professionals operating across 110 countries. Known for its scientific excellence and global reach, Syneos helps bring life-changing therapies to patients faster by integrating clinical development, regulatory affairs, and commercialization expertise.
Work Mode: On-site | Location: Pune, India
Call-to-Action:
Are you ready to advance your CRA career with a global biopharma leader? Apply now to join Syneos Health as a Senior CRA I – Ophthalmology and help accelerate meaningful medical breakthroughs.
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