Are you seeking a rewarding career in clinical research? Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is currently seeking a Clinical Research Associate II (CRA II) to join their dynamic team in India. This position will be essential in accelerating the delivery of life-changing therapies by simplifying and streamlining clinical development.
About Syneos Health
Syneos Health® is dedicated to bringing the customer and the patient to the forefront of everything we do. With 29,000 employees across 110 countries, we are passionate about developing our people and committed to a culture that allows everyone to authentically be themselves. Our Total Self culture unites us globally, promoting diversity of thought, backgrounds, cultures, and perspectives. Join us, and discover how your work matters everywhere!
Role Overview
As a Clinical Research Associate II, your main responsibilities will include:
- Performing site qualification, initiation, monitoring, management activities, and close-out visits, ensuring compliance with regulatory requirements, ICH-GCP guidelines, and study protocols.
- Assessing and documenting the informed consent process and ensuring patient confidentiality and safety.
- Conducting Source Document Reviews, verifying clinical data accuracy, and applying query resolution techniques.
- Managing investigational product inventory, ensuring compliance with handling and dispensing protocols.
- Regularly reviewing and reconciling the Investigator Site File (ISF) with the Trial Master File (TMF) to maintain accuracy and compliance.
- Documenting activities through report writing and data entry into tracking systems.
- Acting as the primary liaison with study site personnel, ensuring all site team members are trained and compliant.
Qualifications
To thrive in this role, you should have:
- A Bachelor’s degree or RN in a related field, or equivalent education, training, and experience.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
- Strong computer skills and the ability to adapt to new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Willingness to travel up to 75% on a regular basis.
