Clinical Research Nurse​/Coordinator

Clinical Research Nurse / Clinical Research Coordinator

Schedule: Monday–Friday, On-Site

Experience: Clinical Nursing & Clinical Research Experience Preferred

We are seeking a Clinical Research Nurse / Clinical Research Coordinator to join our clinical research team at our site in Hamden, Connecticut
.

This is a hands-on, full-time position requiring five days per week on-site
. The role is ideal for an experienced Registered Nurse who is interested in, or has experience with, clinical research and enjoys combining direct patient care with the coordination and management of clinical trials.

The successful candidate will work closely with the Principal Investigator, Sub-Investigators, study participants, sponsors, CROs, and the research team to ensure studies are conducted safely, efficiently, and in accordance with study protocols and applicable regulations.

Our current and upcoming clinical research portfolio includes studies in:

• Allergy
• Cardiometabolic disease
• Obesity and weight management

• Coordinate the day-to-day activities of assigned clinical research studies.
• Ensure study activities are performed in accordance with the protocol, Good Clinical Practice (GCP), FDA requirements, and site SOPs.
• Coordinate and conduct study visits from screening and baseline through follow-up and study completion.
• Review study protocols and ensure all required assessments and procedures are completed within the specified timelines.
• Maintain accurate, complete, and organized clinical and research records.
• Provide oversight of participant medical records and study documentation.
• Ensure source documentation is accurate, current, and appropriately maintained.
• Complete and maintain case report forms and electronic data capture (EDC) systems.
• Assist with recruitment, prescreening, screening, enrollment, and participant retention.
• Coordinate laboratory testing, imaging, specialty assessments, and other protocol-required procedures.
• Communicate with sponsors, CROs, monitors, laboratories, and other study partners.
• Prepare for and participate in monitoring visits, audits, and regulatory inspections.
• Identify and appropriately document protocol deviations, adverse events, and other safety information.
• Assist with study start-up, regulatory documentation, and study close-out activities.

• Provide professional nursing care to clinical research participants.
• Perform nursing assessments and routine clinical evaluations.
• Obtain vital signs, ECGs, blood samples, and other protocol-required specimens.
• Perform phlebotomy and other clinical procedures as required.
• Participate in medical procedures and assessments related to study protocols.
• Administer investigational products and other medications as permitted by the protocol and applicable regulations.
• Monitor participants for adverse events, changes in clinical status, and treatment-related concerns.
• Recognize and appropriately
• Provide participants with education regarding study procedures, medications, appointments, and ongoing participation.
• Perform routine nursing responsibilities while ensuring the specific requirements of each clinical trial are met.
• Maintain accurate and timely nursing and clinical documentation.
• Promote participant safety, comfort, and confidentiality throughout the research process.

• Active Registered Nurse (RN) license in Connecticut.
• Nursing degree from an accredited institution.
• Clinical nursing experience, preferably in an outpatient, ambulatory, specialty, or clinical research setting.
• Previous experience as a Clinical Research Coordinator (CRC) is highly desirable.
• Experience working with clinical research protocols and study participants preferred.
• Familiarity…