SUMMARY

SerenaGroups is the premier clinical trials company serving the wound care industry. As a Clinical Research Associate (CRA), you will manage and monitor trial sites to ensure data integrity, patient safety, and protocol adherence. You will oversee site selection, initiation, monitoring, and close-out visits, keep study documentation organized, and function as the main point of contact between the sponsor and clinical sites.

QUALIFICATIONS AND REQUIREMENTS

• A Bachelor’s degree in nursing or a related field
• 2+ years of experience as a wound care nurse
• Strong wound care knowledge, including medical terminology, clinical practices, and regulatory policies related to wound healing and treatments.
• In-depth understanding of FDA regulations, GCP, and other relevant clinical trial guidelines
• Proficiency with Microsoft Office and experience with electronic data capture (EDC) systems and databases
• Excellent communication, organization, time management, and critical thinking skills

ESSENTIAL FUNCTIONS

• Conduct site initiation, monitoring, and close-out visits to ensure compliance with the study protocol, ethical standards, and regulatory requirements.
• Review and verify case report forms (CRFs) and source documents for accuracy and completeness; maintain essential study documentation.
• Monitor adherence to protocols, Good Clinical Practice (GCP), and applicable regulations.
• Serve as the primary contact between the study sponsor and clinical sites, building strong relationships with investigators and staff to address issues and keep studies moving forward.
• Protect patient rights, safety, and well-being throughout the trial, including verifying informed consent procedures.
• Report and help resolve adverse events promptly; document any deficiencies or issues observed during site visits and prepare monitoring visit reports.
• Provide training to site staff on protocols, data collection, and best practices.

ACCOUNTABILITY

You will ensure data accuracy, proper handling of investigational products, timely reporting of adverse events, provide site staff training, and maintain compliance with Good Clinical Practice (GCP) and regulatory requirements.