Clinical Research Coordinator II - Cancer Center

Dartmouth Health - Lebanon, NH

Full-time - Mid Level

Lebanon, NH

Ambulatory Health Care Services

About the position

The Clinical Research Coordinator II plays a vital role in managing and executing clinical research studies at a skilled level. This position requires a comprehensive understanding of the clinical research process and relevant regulations, with an emphasis on progressively taking on more complex responsibilities. The coordinator works closely with the Principal Investigator (PI) and is responsible for various aspects of study operations, including subject management, regulatory compliance, and data management, while ensuring ethical conduct and participant safety.

Responsibilities

• Occasionally perform tasks outside of defined operating hours.
• Arrange and schedule required tests and appointments for study participants.
• 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, including managing tasks related to Institutional Review Boards (IRBs) and study sponsors.
• Implement Good Clinical Practice (GCP) and Human Subjects Protection (HSP) practices in research activities.
• Assist in the design of studies to include safeguards for ethical conduct and protection of vulnerable populations.
• Utilize Electronic Data Capture (EDC) systems for study operations, including scoring tests and completing Case Report Forms (CRFs).
• Develop data collection documents and procedures for data quality assurance.
• Monitor data capture and management, identifying potential issues and suggesting solutions.
• Adhere to processes for data security and quality monitoring.
• Understand and employ professional guidelines and ethics related to clinical research.
• Travel to investigator meetings or protocol-specific training as needed.
• Organize and manage clinical trials and research studies, conducting protocol reviews for feasibility.
• Collaborate with study investigators to develop recruitment and screening procedures and compose informed consent forms.
• Serve as a liaison between principal investigators, regulatory agencies, and study participants.

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.