Clinical Research Associate I

Qualifications

• Bachelor's degree in life science/related field, advanced degree preferred.
• Minimum of 2+ years in clinical research industry.
• Solid understanding of GCP guidelines, regulatory requirements (e.g., FDA, EMA), and clinical trial processes.
• Excellent organizational, communication, and interpersonal skills
• Ability to travel to and from clinical sites and manage the demands of site visits.
• Capacity to work with and review large volumes of documentation and data.
• Combination of office work and travel to clinical sites, which may include healthcare environments and other clinical settings.

Responsibilities 

• Assist in the preparation and initiation of clinical trial sites, including site qualification and initiation visits.
• Conduct routine monitoring visits to assess site compliance with study protocols, GCP, and regulatory requirements.
• Ensure that the site is properly conducting the study and addressing any issues or concerns that arise.
• Review source documents and verify data against case report forms (CRFs) to ensure accuracy and completeness.
• Identify discrepancies or issues in data entry and work with site staff to resolve them.
• Assist in the collection and submission of essential documents and study materials.
• Ensure that all study-related documentation is accurate, complete, and up-to-date.
• Maintain organized records of monitoring activities, site correspondence, and study data.
• Assist in preparing for and managing audits or inspections by regulatory agencies.
• Serve as a point of contact for site staff, addressing questions and providing support as needed.
• Communicate effectively with the study team, including updates on site performance and any issues encountered.
• Provide support in the training of site staff on study protocols and procedures.
• Assist with the preparation and review of study documents, including monitoring reports and site visit reports.
• Support the study team in ensuring adherence to study timelines and deliverables.