Clinical Research Associate

Summary:

The Clinical Research Associate (CRA) is responsible for monitoring and coordinating clinical trials to ensure compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The CRA works closely with clinical sites, study teams, and sponsors to ensure that clinical trials are conducted efficiently, safely, and ethically.

Responsibilities:

Site Management:

• Initiate, monitor, and close out clinical trial sites according to study protocols.
• Conduct site visits to ensure the site adheres to study protocols, GCP, and regulatory requirements.
• Verify that trial data is accurate, complete, and verifiable from source documents.
• Ensure that the investigational product is handled and stored per the protocol and regulatory requirements.

1. Monitoring Activities:

• Perform on-site and remote monitoring of clinical trials.
• Review and verify case report forms (CRFs) and source documentation.
• Ensure proper reporting and documentation of adverse events and protocol deviations.
• Maintain regular communication with site staff to ensure compliance and troubleshoot any issues.

Regulatory Compliance:

• Ensure that clinical trials are conducted in accordance with GCP, applicable regulations, and study protocols.
• Assist with the preparation and submission of regulatory documents.
• Ensure that informed consent is obtained and documented for all study participants.

Documentation and Reporting:

• Prepare and maintain accurate study files, including monitoring visit reports, correspondence, and site records.
• Report on the progress of clinical trials to the study team and sponsors.
• Provide regular updates on site performance, including recruitment, data quality, and compliance.

1. Collaboration and Communication:

• Work closely with the study team, investigators, and site staff to ensure successful execution of clinical trials.
• Participate in study team meetings and teleconferences.
• Assist in the resolution of any issues that arise during the trial.

Training and Support:

• Provide training to site staff on study protocols, GCP, and regulatory requirements.
• Assist with the development of study tools and training materials.
• Support site staff in the use of electronic data capture (EDC) systems and other study-related technology.

Qualifications:

• Education: A bachelor’s degree in life sciences, nursing, pharmacy, or a related field. Advanced degrees or certifications in clinical research are advantageous.
• Experience: Prior experience in clinical research, with specific experience in monitoring clinical trials. Knowledge of GCP and regulatory requirements is essential.
• Skills:
  • Strong organizational and time-management skills.
  • Excellent communication and interpersonal skills.
  • Attention to detail and ability to work independently.
  • Proficiency in electronic data capture systems and other clinical trial management tools.
• Certifications: Certifications such as Certified Clinical Research Associate (CCRA) or equivalent are preferred.

Work Environment:

• The CRA role involves both office-based and fieldwork, with travel to clinical trial sites required. The position may involve national or international travel depending on the trial locations.