Research Coordinator III - OB-GYN

Dartmouth Health - Lebanon, NH

Full-time

Lebanon, NH

Ambulatory Health Care Services

About the position

The Clinical Research Coordinator III is responsible for overseeing and executing comprehensive clinical trial duties for multiple or complex clinical trials. This role requires advanced skills in research operations, ethics, data management, and leadership, with a focus on ensuring the productivity and success of clinical research programs. The coordinator works with limited supervision, actively participates in decision-making, and leads teams to achieve research objectives while adhering to regulatory compliance and ethical standards.

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).
• Carries out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision by the investigator.
• Interviews study participants about their medical history, medications, adverse events, demographics, and quality of life issues, with review by the principal investigator.
• Prepares and submits regulatory documents to study sponsors and regulatory agencies.
• Maintains study and regulatory documentation, ensuring all staff involved in the study are trained and that training is documented.
• Supports the evaluation of staff and assures compliance with GCP and HSP practices.
• Assists in the design of studies to include safeguards for ethical conduct and protection of vulnerable populations.
• Trains others on the proper utilization of Electronic Data Capture (EDC) systems and technologies necessary for study operations.
• Develops and implements data collection documents and instruments, ensuring accuracy and completeness of data.
• Designs and develops Standard Operating Procedures (SOPs) for data quality assurance.
• Monitors data quality and escalates issues as appropriate.
• Provides guidance, oversight, and mentoring to team members in service excellence and professionalism.
• Independently organizes and manages clinical trials and research studies, conducting protocol reviews and participating in study site selection activities.
• Composes informed consent forms and protocol abstracts, and may participate in manuscript/abstract development.
• Serves as a liaison between principal investigators, regulatory agencies, and study participants to resolve problems.

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.