Title: Clinical Research Coordinator I

Location: RBA/Staten Island

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 22 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ 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.

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.

Responsibilities:

• Obtains detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator and Site Director prior to the effective date of the study.
• Assist to develop draft source documents and review the documents for accuracy and clarity prior to study start up.
• Reviews with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
• Manages studies with direct oversight from Site Director, and Principal Investigator to ensure compliance with protocol requirements.
• Manages studies with Principal Investigator, Site Director, and Recruitment Manager to develop effective programs for study enrollment.

Study Management

• Perform study activities as delegated by the Principal Investigator and under the supervision of the Site Director.
• Attends the investigator meeting for each assigned protocol, as appropriate with directive from Site Director.
• In conjunction with Site Director and Principal Investigator, ensure adherence to the protocols and document breaches or violations with sponsors and appropriate Institutional Review Boards (IRBs) and other outside regulatory organizations, as required.
• Screen, enroll subjects and schedule subject visits in conjunction with Principal Investigator
• Review and obtain informed consent from with potential study volunteer
• Document all written and phone correspondences with sponsor, labs, IRB other regulatory organizations
• Assist Principal Investigator in conducting studies in manner to ensure integrity of data and safety of subjects.
• In conjunction with Principal Investigator, accurately report and track adverse events as defined by each study protocol

Skills and Qualifications:

• Education and experience
  • High School Diploma or its equivalent; College degree preferred.
  • 1 year of research experience preferred.
  • Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology to communicate with physician office and laboratory staff.
• Requirements
  • Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
  • Excellent communication skills (interpersonal, written, verbal)
  • Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Benefits:

• Matching 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Paid time off
• Vision insurance