Clinical Research Coordinator

Clinical Research Coordinator

Location: Staten Island, NY

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Job Description

The Clinical Research Coordinator is responsible for the overall coordination, organization, management, and efficient implementation of clinical trials. The CRC completes all study related procedures and distributes study medication and instructions to research subjects under the direction of the Principal Investigator and the Site Director. They maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Clinical Research Coordinator is guided by FDA regulations, Good Clinical Practice (GCP), and company standard operating procedures and policies.

Responsibilities

General:

• Obtain detailed knowledge of study protocols by reviewing with Principal Investigator (PI) and Site Director.
• Assist in drafting and reviewing source documents for accuracy before study start-up.
• Collaborate with PI and Site Director to clarify study components as needed.
• Manage studies under the guidance of PI and Site Director to ensure protocol compliance.

Study Management:

• Perform delegated study activities under Site Director's supervision.
• Attend investigator meetings as directed.
• Ensure protocol adherence and report breaches to sponsors and regulatory bodies.
• Screen, enroll subjects, schedule visits, and document communications.
• Assist PI in maintaining data integrity and subject safety.
• Enter study data (paper or electronic) and track adverse events.
• Conduct study close-out procedures.

Additional Responsibilities:

• Take on evolving tasks as required by the organization.

Skills and Qualifications

• High School Diploma required; college degree preferred.
• 2-4 years of experience or Clinical Research Coordinator certification.
• Strong communication, medical terminology knowledge, and problem-solving skills.
• Familiarity with GCP, ICH guidelines, and regulatory requirements.
• Proficient in Word, Excel, and clinical research software.