Instagram
youtube
Facebook

Sr Cra I (Ophthalmology Experience)

4+ years
Not Disclosed
10 July 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 (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.