Clinical Research Coordinator

Job Summary

The Clinical Study Coordinator will manage and oversee clinical research studies to ensure compliance with clinical and regulatory standards. The position involves planning, coordinating, and executing research activities, while ensuring the safety of participants and the quality of data collected.

Location: Irvington, NJ

Responsibilities

· Coordinate and conduct clinical research studies in accordance with study protocols.

· Ensure that clinical trials are conducted according to all relevant regulations and ethical guidelines.

· May collect, record, and maintain study data, ensuring it is accurate and complete into sponsor EDC.

· Manage all study-related documentation, ensuring accuracy and compliance.

· Assist with the preparation and submission of regulatory documents.

· Schedule study-related procedures and follow up with participants.

· Maintain communication with investigators, sponsors, and regulatory bodies.

· Monitor patient safety, including reporting adverse events.

· Ensure the study is conducted within the allocated budget and timeline.

· Attend team meetings and provide updates on study progress.

Qualifications

· Minimum requirement - LPN or RN with an Associate Degree

· 1-2 years experience with running an internal medicine clinic

· Must have Venipuncture skills working with Pediatric and Adult population

· Extensive experience in handling drug accountability for vaccines, biologics, or capsules

· Knowledgeable on of HIPAA, OHRP, FDA and state regulations required

· Must have a good working knowledge of ICH-Good Clinical Practice guidelines

· IATA Certification preferred but not required

· Experience with ethics committee submission but not required.

Skills Required

· Excellent organizational skills, communication, interpersonal skills.

· Must be able to show empathy and or compassion with the patient population.

· Good Microsoft Office, Ms-Excel and documentation skills.

· Must be flexible to work 4-5 days per week.

Job Type: Contract to Hire (6 months)

Work Environment: Clinic (on-site)