Job Title: CRA II / Sr CRA I (Oncology – Mumbai, Client-based)
📅 Updated: September 17, 2025
📍 Location: Mumbai, India (Client-based)
🆔 Job ID: 25101933
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. With 29,000 employees across 110 countries, we translate clinical, medical affairs, and commercial insights into outcomes that change patients’ lives.
Our model keeps the customer and patient at the center, streamlining processes, driving innovation, and accelerating delivery of therapies.
💡 Work Here Matters Everywhere.
Why Join Us?
Career growth and progression opportunities.
Supportive and engaged line management.
Access to technical and therapeutic area training.
Peer recognition and total rewards program.
Inclusive Total Self culture where authenticity and belonging thrive.
Key Responsibilities
Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remote).
Ensure compliance with ICH-GCP, GPP, regulatory requirements, and study protocols.
Evaluate site performance and escalate issues promptly with action plans.
Verify informed consent procedures and subject safety/confidentiality.
Perform Source Document Review, data verification, and query resolution.
Support site compliance with electronic data capture requirements.
Review and reconcile investigator site files (ISF) with the Trial Master File (TMF).
Verify investigational product (IP) inventory, storage, dispensing, and reconciliation.
Document activities via trip reports, confirmation letters, and communication logs.
Support subject/patient recruitment and retention strategies.
Manage site-level project activities, budgets, and timelines.
Liaise with site staff, sponsors, and internal teams.
Provide site and project-level support for audit readiness.
Prepare for and attend Investigator Meetings, sponsor meetings, and training sessions.
For Real World Late Phase: support site identification, chart abstraction, data collection, and collaboration with local stakeholders.
Qualifications & Experience
🎓 Education: Bachelor’s degree or RN in a related field (or equivalent combination of education/experience).
🧪 Experience:
3–5 years of monitoring experience.
Therapeutic expertise in Oncology (plus Hematology, Cardiology, Neuropsychiatry, Rare Diseases, Immunology preferred).
Background in pharma/clinical research.
💻 Skills:
Knowledge of ICH-GCP guidelines and regulatory requirements.
Proficiency in computer systems and willingness to adopt new technologies.
Excellent communication, presentation, and interpersonal skills.
✈️ Travel: Ability to travel up to 75% regularly.
Additional Information
This posting is for an upcoming opportunity, not an immediate vacancy. Candidates expressing interest will join the talent pipeline.
Tasks and responsibilities listed are not exhaustive; equivalent qualifications or experience may be considered.
Committed to diversity, inclusion, and equal opportunity.
About Syneos Health Impact
Partnered on 94% of FDA novel drug approvals and 95% of EMA-authorized products over the past 5 years.
Worked across 200+ studies, 73,000 sites, and 675,000+ patients globally.
A company where employees challenge the status quo in a competitive, evolving environment.
🌐 Learn more: www.syneoshealth.com
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