About the Role
The Research (LPN) manages and oversees clinical trials, ensuring compliance with regulatory standards and study protocols. This role coordinates patient recruitment, data collection, and communication to facilitate smooth trial operations, maintain data integrity, and advance medical research.
Responsibilities
- Coordinate and manage daily clinical trial activities including patient screening, enrollment, and follow-up visits.
- Ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Collect, record, and maintain accurate clinical data and patient records in electronic data capture systems.
- Serve as the primary liaison between patients, investigators, and sponsors to facilitate communication and resolve issues.
- Monitor patient safety and report adverse events promptly according to protocol and regulatory guidelines.
- Schedule and conduct study visits, including obtaining informed consent and performing clinical assessments.
- Assist in the preparation and submission of regulatory documents and study reports.
- Maintain inventory of study supplies and ensure proper storage of investigational products.
Requirements
- Licensed Practical Nurse (LPN) credential in the United States.
- Basic knowledge of clinical research principles and regulatory requirements.
- Experience in patient care and clinical procedures.
- Strong organizational and communication skills.
- Ability to work collaboratively in a multidisciplinary team environment.
- Previous experience as a Clinical Research Coordinator or in clinical trial settings.
- Certification in Clinical Research (e.g., CCRC or equivalent).
- Familiarity with electronic data capture (EDC) systems and clinical trial management software.
- Knowledge of FDA regulations and Institutional Review Board (IRB) processes.
- Experience with patient recruitment and retention strategies.
Skills
- Clinical nursing skills for patient assessments, treatments, and safety monitoring.
- Strong organizational skills for managing protocols, scheduling, and documentation.
- Effective communication skills for interactions with patients, investigators, and sponsors.
- Knowledge of regulatory guidelines and clinical research processes.
- Proficiency with electronic data systems for accurate data entry and reporting.
Education Level
- Licensed Practical Nurse (LPN) credential
