Clinical Research Coordinator

1 month ago

Bengaluru, India Clinogenesis Research Institute Full time

The Clinical Research Associate (CRA) is responsible for managing and monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. This role involves coordinating with clinical site staff, verifying data, and ensuring high standards for patient safety and data integrity. The CRA plays a crucial role in the clinical development process, acting as a bridge between the clinical trial site and the study sponsor.

Key Responsibilities:
  1. Site Management & Monitoring
  • Conduct on-site and remote monitoring visits to ensure site compliance with study protocols and regulatory standards.
  • Verify data accuracy by performing source data verification (SDV), ensuring that clinical data aligns with protocol requirements.
  • Assist with site start-up activities, including training site staff and supporting regulatory and ethics submissions.
Regulatory Compliance & Quality Control
  • Ensure that clinical trials are conducted in adherence to GCP, FDA, and ICH guidelines as well as internal SOPs.
  • Review and maintain essential study documents, including informed consent forms, case report forms, and regulatory submissions.
  • Identify, document, and follow up on any protocol deviations, working with the site to resolve and prevent recurrence.
Data Collection & Verification
  • Ensure accurate data collection, addressing data queries, and conducting periodic data quality assessments.
  • Monitor patient recruitment, enrollment, and retention to ensure study timelines are met.
  • Track study progress and maintain detailed site visit reports, follow-up letters, and communications.
Communication & Site Support
  • Serve as the primary point of contact between the sponsor and the site, facilitating clear, timely communication.
  • Provide ongoing training and support to site staff on protocol requirements, study procedures, and regulatory standards.
  • Collaborate with cross-functional teams, including data management, regulatory, and safety teams, to ensure study goals are achieved.
Risk Management & Troubleshooting
  • Identify potential risks related to patient safety or data integrity and take proactive steps to mitigate them.
  • Address and document any issues that arise, escalating as necessary to ensure compliance with regulatory and protocol standards.

Requirements

Bachelor’s degree in life sciences, nursing, pharmacy, or a related field; advanced degree preferred.

Minimum 1-3 years of experience in clinical research, ideally as a Clinical Research Coordinator or CRA.

Strong knowledge of GCP, FDA regulations, and ICH guidelines.

Experience with Electronic Data Capture (EDC) systems and familiarity with Clinical Trial Management Systems (CTMS).

Benefits

Competitive compensation package, including travel allowances for site visits.

Opportunities for career growth within clinical research and the broader life sciences field.

Professional development and training opportunities in advanced clinical research methodologies.

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