Clinical Project Assistant
SanofiÂ
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Job Description
Location: India (Remote)
Job Category: Clinical Operations / Monitoring
Job Type: Full-Time (Remote)
About the Role
CUS Tech is seeking a detail-oriented Clinical Research Associate (CRA) to join our growing global team. In this role, you will be responsible for monitoring clinical trials, ensuring adherence to regulatory standards, and supporting the execution of study protocols with precision and integrity.
As a CRA, you will work closely with investigators, clinical sites, and cross-functional teams to ensure accurate data collection, compliance with Good Clinical Practice (GCP), and the protection of patient safety throughout the clinical trial process.
Role & Responsibilities
- Monitor clinical trial activities to ensure compliance with protocols, SOPs, and regulatory requirements.
- Conduct site visits, including initiation, monitoring, and close-out activities.
- Review and verify Case Report Forms (CRFs) for completeness and accuracy.
- Support site selection, investigator training, and performance evaluation.
- Identify, document, and report protocol deviations, issues, and adverse events in a timely manner.
- Collaborate with clinical operations, data management, and medical affairs teams.
- Maintain essential study documentation and assist with regulatory submissions.
- Ensure data integrity and patient safety throughout the study lifecycle.
Educational Qualification
- Bachelorâs or Masterâs degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Strong knowledge of GCP, ICH guidelines, and clinical research regulations.
  Experience & Skills
- Solid understanding of clinical trial design, documentation, and reporting requirements.
- Excellent attention to detail, analytical thinking, and problem-solving skills.
- Proficient in Microsoft Office and Clinical Trial Management Systems (CTMS).
- Effective communication and interpersonal skills for interacting with site staff and investigators.
Location
Remote, India
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