Clinical Research Associate

About the job

A Clinical Research Associate (CRA) is a professional who plays a critical role in the field of clinical research. Their primary responsibility is to ensure that clinical trials are conducted in accordance with applicable regulations guidelines and protocols.

Key Responsibilities

• Protocol Compliance: Ensure that clinical trials are conducted according to the approved study protocols Standard Operating Procedures (SOPs) Good Clinical Practice (GCP) and applicable regulatory requirements.
• Site Selection and Initiation: Identify and evaluate potential investigational sites for participation in clinical trials. Conduct site initiation visits train site staff on protocol requirements and ensure all necessary documentation is in place.
• Monitoring: Perform routine monitoring visits to assigned sites to verify the integrity of clinical data and ensure compliance with study procedures. Collect review and verify source documentation and case report forms (CRFs) for accuracy and completeness.
• Data Management: Collaborate with data management personnel to ensure accurate and timely data collection reporting and resolution of data queries. Review data listings and tables to identify discrepancies or inconsistencies.
• Safety Reporting: Monitor and report adverse events (AEs) and serious adverse events (SAEs) to the sponsor ethics committees and regulatory authorities as required by regulations and protocols.
• Regulatory Compliance: Ensure that all required regulatory and ethics committee submissions are completed accurately and in a timely manner. Assist in the preparation and review of regulatory documents such as clinical trial applications and informed consent forms.
• Documentation and Record Keeping: Maintain trialrelated documentation including study files essential documents and correspondence. Ensure that all trialrelated materials are complete organized and stored securely.
• Relationship Management: Establish and maintain effective relationships with investigators study coordinators and site personnel to facilitate study conduct and address any issues or concerns that arise during the trial.
• Study Closeout: Conduct site closeout visits and ensure that all required study documentation and supplies are returned to the sponsor or properly archived. Assist in the preparation of study reports and final study data for submission to regulatory authorities.
• Continuous Learning: Stay updated on relevant regulations guidelines and industry best practices. Attend training sessions and professional conferences to enhance knowledge and skills in clinical research.

Qualifications And Skills

• Bachelors degree in a scientific or healthcarerelated field (or equivalent experience) such as MSc. Clinical Research M. Pharm Pharm D medical and Paramedical degree.
• Strong knowledge of Good Clinical Practice (GCP) guidelines and relevant regulatory requirements (e.g. FDA ICH).
• Prior experience working as a Clinical Research Associate or in a related role is preferred.
• Excellent organizational communication and interpersonal skills.
• Attention to detail and ability to work independently and as part of a team.
• Proficiency in using clinical trial management systems and electronic data capture systems.
• Willingness to travel to clinical trial sites as needed (domestic and international)

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Remote Work :

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