Clinical Research Associate II
Updated: November 11, 2024
Location: India (Home-Based)
Job ID: 24005945
About Syneos Health
Syneos Health® is a leading biopharmaceutical solutions company focused on accelerating customer success through integrated clinical, medical affairs, and commercial strategies. With over 29,000 employees in 110 countries, we are driven to bring therapies to market faster, changing lives through innovation and collaboration.
Why Join Us?
At Syneos Health, we foster a culture where you can:
Develop your career with robust training, mentorship, and progression opportunities.
Be your authentic self through our Total Self culture, uniting us globally.
Work in an inclusive environment that values diversity of thought, background, and experience.
Experience the satisfaction of contributing to groundbreaking research and therapies.
Key Responsibilities
Clinical Monitoring & Site Management:
Conduct site qualification, initiation, interim monitoring, and close-out visits (remote/on-site).
Ensure regulatory, ICH-GCP, and protocol compliance, and immediately escalate issues to the project team.
Verify informed consent process and documentation for each patient while ensuring confidentiality.
Data Management & Quality Assurance:
Review and validate clinical data entered in case report forms (CRFs) for accuracy and completeness.
Reconcile Investigator Site Files (ISF) with the Trial Master File (TMF).
Manage investigational product (IP) inventory, reconciliation, and compliance with protocols.
Site Collaboration:
Act as a liaison with site personnel and study teams, providing training and ensuring compliance.
Support patient recruitment, retention, and awareness strategies.
Prepare for and attend Investigator Meetings and sponsor face-to-face sessions.
Regulatory Adherence:
Support audit readiness and follow-up actions.
Maintain working knowledge of ICH-GCP Guidelines, applicable regulations, and company SOPs.
Real World Late Phase Responsibilities:
Site support from identification through close-out.
Conduct chart abstraction and collaborate with sponsor affiliates and local staff.
Identify out-of-scope activities and proactively recommend potential sites.
Qualifications
Minimum 3 years of experience in on-site and remote monitoring.
Expertise in therapeutic areas such as Neurology, Immunology, Rare Diseases, CVD, and Oncology.
Bachelor’s degree or RN (or equivalent combination of education, training, and experience).
Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and regulatory requirements.
Strong computer skills and ability to adopt new technologies.
Excellent communication, presentation, and interpersonal skills.
Ability to travel up to 75%.
Preferred Locations: Mumbai, Delhi, Bengaluru, Hyderabad, Ahmedabad.
Why Syneos Health?
Over the past 5 years, we’ve worked with 94% of FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies. Join us in shaping the future of healthcare.
Additional Information:
Syneos Health is committed to equal opportunity and diversity in hiring. Reasonable accommodations will be provided as needed in compliance with applicable laws.
Explore your career with Syneos Health: Learn More Here
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