Clinical Research Coordinator II - Gastroenterology

Dartmouth Health - Lebanon, NH

Full-time

Lebanon, NH

Ambulatory Health Care Services

About the position

The Clinical Research Coordinator II at the Center for Digestive Health is responsible for supporting a growing portfolio of clinical trials by performing a range of clinical research duties. This role requires a solid understanding of the clinical research process and relevant regulations, with an emphasis on progressively complex tasks and increased independence. The coordinator works closely with the Principal Investigator (PI) and is involved in various aspects of study operations, including subject management, regulatory documentation, and data management.

Responsibilities

• Arrange and/or schedule required tests and other appointments.
• Support all aspects of study operations, including subject management and regulatory compliance, under the oversight of the investigator or their designee.
• Manage subject data entry in the Clinical Trial Management System (CTMS) and scan informed consents into the Electronic Medical Record (EMR).
• Administer Quality of Life (QoL) questionnaires under the supervision of the investigator.
• Interview study participants about medical history, medications, adverse events, demographics, and quality of life issues, with review by the PI.
• Communicate with participants throughout the study and provide education and support to them and their families.
• Prepare and submit regulatory documents to study sponsors and regulatory agencies.
• Maintain study and regulatory documentation.
• Manage study tasks related to Institutional Review Boards (IRBs) and study sponsors, as well as regulatory committees.

Requirements

• Bachelor's degree and 2 years of relevant research experience or equivalent years of experience.
• Ability to travel as required.
• BLS certification required within 30 days of hire.

Nice-to-haves

• SOCRA/ACRP Certification or eligibility for certification preferred.