Clinical Research Coordinator (LPN) In-person in Cortland, New York at Smith Allergy and Asthma

About the Role:

The Clinical Research Coordinator (LPN) plays a pivotal role in managing and overseeing clinical trials to ensure they are conducted in compliance with regulatory standards and study protocols. This position involves coordinating patient recruitment, data collection, and communication between study participants and the research team to facilitate smooth trial operations. The coordinator ensures accurate documentation and reporting of clinical data, maintaining the integrity and confidentiality of patient information. By collaborating closely with investigators, sponsors, and regulatory bodies, the coordinator helps advance medical research and contributes to the development of new treatments. Ultimately, this role supports the successful execution of clinical studies that improve patient outcomes and advance healthcare knowledge.

Minimum Qualifications:

• 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.

Preferred Qualifications:

• 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.

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.

Skills:

The Clinical Research Coordinator (LPN) utilizes clinical nursing skills daily to perform patient assessments, administer treatments, and monitor patient safety during trials. Strong organizational skills are essential for managing multiple study protocols, scheduling visits, and maintaining accurate documentation. Effective communication skills facilitate clear interactions with patients, investigators, and sponsors, ensuring all parties are informed and engaged. Knowledge of regulatory guidelines and clinical research processes ensures compliance and ethical conduct throughout the study lifecycle. Additionally, proficiency with electronic data systems supports accurate data entry and reporting, which is critical for the integrity and success of clinical trials.