Syneos Health® is a fully integrated biopharmaceutical solutions organization that focuses on accelerating customer success through clinical, medical affairs, and commercial insights. With a commitment to innovation, the company is driven to bring therapies to market faster, positively impacting patients’ lives worldwide.
Clinical Research Associate I (CRA I) – Syneos Health (Mumbai Location)
Position Overview:
As a Clinical Research Associate I (CRA I) based in Mumbai, you will play a key role in the management of clinical trials. You will be responsible for ensuring that trial sites adhere to regulatory requirements, Good Clinical Practice (GCP), and protocol compliance, contributing to the success of clinical projects.
Key Responsibilities:
- Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits, ensuring compliance with regulatory guidelines, GCP, and protocol requirements.
- Informed Consent Verification: Ensure the process of obtaining informed consent is adequately performed and documented for each subject, maintaining confidentiality and safety.
- Clinical Monitoring: Review site processes, source documents, and medical records to verify that clinical data entered in the case report forms (CRFs) are accurate and complete.
- Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and compliance with storage and security requirements. Ensure proper labeling, importation, and return of IP.
- Documentation: Maintain accurate documentation through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
- Project Scope and Timelines: Understand project scope, budgets, and timelines. Manage site-level activities and communications to meet project objectives and deliverables.
- Liaison Role: Act as a primary contact with project site personnel, ensuring site and project-specific team members are trained and compliant with applicable requirements.
- Audit Readiness: Provide guidance towards audit readiness standards and support preparation for audits, including required follow-up actions.
- Real World Late Phase Studies: For late-phase studies, perform additional responsibilities such as site support, chart abstraction, data collection, and collaboration with sponsor affiliates.
Qualifications:
- Education: Bachelor’s degree or RN in a related field, or an equivalent combination of education, training, and experience.
- Knowledge: Strong understanding of Good Clinical Practice (GCP) and ICH Guidelines, along with other applicable regulatory requirements.
- Technical Skills: Proficiency in computer skills and the ability to adapt to new technologies.
- Interpersonal Skills: Excellent communication, presentation, and interpersonal skills are essential.
- Travel Requirements: Willingness and ability to manage up to 75% travel on a regular basis.
Contract Details:
- Duration: 6-month contract with client-based responsibilities.
Why Work at Syneos Health?
Syneos Health offers a supportive environment focused on career development, technical and therapeutic training, and peer recognition. The company fosters a culture of diversity and inclusion, ensuring that everyone feels like they belong.
