Job Opportunity: Clinical Research Associate I (CRA I) at Syneos Health
Date: September 4, 2024
Location: Mumbai, India
Salary: ₹6.6 Lakhs per year
Experience: 0-2 Years / Freshers Welcome
Organization Overview: Syneos Health
Syneos Health® is a globally integrated biopharmaceutical solutions organization committed to accelerating customer success through clinical, medical affairs, and commercial insights. The company is renowned for its dedication to innovation, bringing therapies to market faster and positively impacting patients’ lives worldwide. Syneos Health values diversity, inclusion, and professional development, fostering a work environment where everyone feels like they belong.
Position Overview: Clinical Research Associate I (CRA I)
As a Clinical Research Associate I (CRA I) at Syneos Health, based in Mumbai, you will play a pivotal role in the management of clinical trials. This position is ideal for fresh graduates or those with up to 2 years of experience in clinical research. You will be responsible for ensuring that trial sites adhere to regulatory requirements, Good Clinical Practice (GCP), and protocol compliance, thus contributing to the success of clinical projects.
Key Responsibilities
- Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits to ensure compliance with regulatory guidelines, GCP, and protocol requirements.
- Informed Consent Verification: Oversee the informed consent process to ensure it 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: Manage 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: Serve as the 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 and Requirements
| Qualification | Requirement |
|---|---|
| Education | B.Pharm, M.Pharm, Pharm.D, MSc, BSc in Life Sciences |
| Experience | 0-2 Years / Freshers Welcome |
| Technical Skills | Proficient in computer skills; ability to adapt to new technologies |
| Knowledge | Strong understanding of GCP, ICH Guidelines, and other applicable regulatory requirements |
| 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. Working at Syneos Health means being part of a team that is committed to advancing innovative therapies and making a difference in patients’ lives.
How to Apply
Interested candidates can apply through the official Syneos Health website or LinkedIn page. Please ensure that you meet the qualifications and are willing to commit to the travel requirements.
Application Deadline: September 30, 2024
Contact: For inquiries, contact Syneos Health HR or visit the Careers Page.
Join Syneos Health and contribute to the future of clinical research!
