Clinical Research Coordinator III

$122,000 - $255,000/Yr

Dartmouth Health - Lebanon, NH

posted 2 months ago

Full-time - Mid Level
Lebanon, NH
Ambulatory Health Care Services

About the position

The Clinical Research Coordinator III at Dartmouth-Hitchcock is responsible for performing a comprehensive range of clinical research duties at an advanced level. This role involves planning, organizing, leading, and executing clinical trial duties for multiple or complex clinical trials, with a focus on enhancing the overall productivity and success of the research program. The Clinical Research Coordinator III is expected to work with limited supervision and actively participate in decision-making processes related to clinical research, often taking the lead in team settings. The decisions made in this role have a significant impact on both internal and external partners, emphasizing the importance of ethical conduct and compliance with regulatory standards. It is crucial to note that this position cannot perform any tasks that require a license as per state or local laws. The responsibilities of the Clinical Research Coordinator III encompass various aspects of research operations, including mentoring and training new staff on Good Clinical Practice (GCP) and Human Subjects Protection (HSP) practices. The coordinator will independently manage study operations, oversee subject management, and ensure compliance with regulatory requirements. They will also play a vital role in participant safety by evaluating staff compliance with ethical standards and communicating the risks and benefits of study participation to research participants. In addition to operational duties, the Clinical Research Coordinator III will be involved in data management, including training others on Electronic Data Capture (EDC) systems, ensuring data accuracy, and developing Standard Operating Procedures (SOPs) for data quality assurance. Leadership and professionalism are key components of this role, as the coordinator will provide guidance and mentorship to team members while adhering to professional guidelines and ethical standards. The position also requires effective communication and collaboration with various stakeholders, including principal investigators, regulatory agencies, and study participants. The Clinical Research Coordinator III will assist in financial management of the research program and may identify new research opportunities, contributing to the overall development and management of the research portfolio.

Responsibilities

  • Mentors, onboards, trains and oversees new clinical research coordinator staff on Good Clinical Practice (GCP), Human Subjects Protection (HSP) practices, and ethical conduct of research.
  • Independently executes all aspects of study operations with minimal oversight from the investigator or their designee.
  • Oversees subject management, including data entry in Clinical Trials Management System (CTMS) and scanning informed consents into Electronic Medical Records (EMR).
  • Prepares and submits regulatory documents to study sponsors and applicable regulatory agencies.
  • Supports the evaluation of staff and assures compliance with GCP and HSP practices.
  • Trains others on the proper utilization of Electronic Data Capture (EDC) systems and technologies necessary for study operations.
  • Independently organizes and manages clinical trials and research studies.
  • Serves as a liaison between principal investigators, regulatory agencies, and study participants to resolve problems.

Requirements

  • Advanced knowledge of clinical research practices and regulations.
  • Experience in managing multiple clinical trials simultaneously.
  • Strong leadership and mentoring skills.
  • Excellent communication and interpersonal skills.
  • Proficiency in data management and analysis, including familiarity with EDC systems.

Nice-to-haves

  • Experience with grant writing and budget preparation.
  • Familiarity with ethical considerations in clinical research.
  • Knowledge of specific therapeutic areas relevant to the studies conducted.

Benefits

  • Sign-on bonus eligibility
  • Comprehensive health insurance
  • 401k retirement plan
  • Paid time off and holidays
  • Professional development opportunities
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