Job Description

We are seeking a detail-oriented and motivated Clinical Research Associate (CRA) to join our clinical operations team in a contract role. The CRA will be responsible for monitoring clinical trials, ensuring compliance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. This role plays a key part in ensuring the safety of study participants and the integrity of the clinical data collected.

Key Responsibilities

• Study Monitoring: Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, SOPs, and regulatory guidelines.
• Compliance Oversight: Ensure adherence to ICH-GCP, FDA regulations, and other applicable local/global regulations.
• Data Quality: Verify accuracy, completeness, and consistency of case report forms (CRFs) and source data. Identify and resolve data discrepancies with investigational sites.
• Site Management: Develop and maintain strong relationships with investigators, site staff, and study coordinators to ensure effective study execution.
• Documentation: Prepare detailed monitoring reports, track site performance, and maintain essential trial documents.
• Issue Resolution: Identify, document, and follow up on protocol deviations, regulatory issues, and other study-related concerns.
• Collaboration: Work closely with project managers, clinical trial managers, and cross-functional teams to support study timelines and deliverables.
• Training & Support: Provide protocol and study-specific training to investigational site staff as needed.
• May help in representing Clinical affairs in new product development teams and or be a clinical functional liaison

Qualifications:

• Bachelor’s degree required. Degree in Life Sciences or health sciences or nursing or other related field preferred.
• Must have at least 2 years of work experience in Clinical Research as a study coordinator or research assistant in a hospital setting or within a CRO. Monitoring experience is a plus.
• Knowledge of clinical trial methodology and GCP/ICH guidelines preferred.
• Experience assisting in clinical operations tasks such as evaluating clinical trial sites and other study start-up, study follow up activities (drafting study manuals, acting as a liaison with clinical sites at various phases of study conduct).
• This individual may help in study budget activities including study related payments, accruals, etc.
• The ideal candidate will have keen attention to detail, be organized, and be a great communicator.
• Some travel may be needed (Not to exceed 20%).

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