Research Coordinator III - OB-GYN

Dartmouth Health - Lebanon, NH

Full-time - Mid Level

Lebanon, NH

Ambulatory Health Care Services

About the position

The OB-GYN position in Lebanon, NH, focuses on managing and conducting the RELIEF trial, a significant multi-center clinical research study aimed at evaluating the effectiveness of reduced-dose onabotulinumtoxinA for treating urgency incontinence among older females. The role involves overseeing research operations, ensuring compliance with ethical standards, and managing data collection and participant interactions, all while collaborating with various stakeholders including patients, caregivers, and healthcare providers.

Responsibilities

• Mentors, onboards, trains, and oversees new clinical research coordinator staff on Good Clinical Practice (GCP) and Human Subjects Protection (HSP) practices.
• Independently executes all aspects of study operations with minimal oversight from the investigator.
• Oversees subject management, including data entry in Clinical Trials Management System (CTMS) and scanning informed consents into Electronic Medical Records (EMR).
• Administers Quality of Life (QoL) questionnaires and interviews study participants about their medical history and quality of life issues.
• Prepares and submits regulatory documents to study sponsors and regulatory agencies.
• Maintains study and regulatory documentation, ensuring compliance with the Institutional Review Board (IRB).
• Supports the evaluation of staff and assures compliance with ethical research practices.
• Trains others on the proper utilization of Electronic Data Capture (EDC) systems and technologies.
• Develops and implements data collection documents and instruments, ensuring data accuracy and completeness.
• Independently organizes and manages clinical trials and research studies, including protocol reviews and site selection activities.

Requirements

• Bachelor's degree or equivalent years of experience.
• Master's degree in a relevant field preferred.
• 4 years of relevant research experience.
• BLS certification required within 30 days of hire.
• SOCRA/ACRP Certifications required.

Nice-to-haves

• Experience in clinical trial management and regulatory compliance.
• Familiarity with data management and electronic data capture systems.

Benefits

• Health insurance coverage.
• Paid holidays and vacation time.
• Professional development opportunities.