Dartmouth Health - Lebanon, NH
posted 2 months ago
The Clinical Research Coordinator II at Dartmouth Health is responsible for performing a comprehensive range of clinical research duties at a skilled level, demonstrating a solid understanding of the clinical research process and the regulations that govern it. This role is designed for individuals who are expected to take on progressively more complex and comprehensive clinical research responsibilities with an increasing level of independence, while working closely with the Principal Investigator (PI). The Clinical Research Coordinator II operates under the supervision and direction of the PI or their designee, ensuring compliance with state and local laws regarding licensure for specific tasks. In this position, the Clinical Research Coordinator II will engage in various research operations, which may occasionally require tasks outside of defined operating hours. Responsibilities include arranging and scheduling necessary tests and appointments, supporting subject management through data entry in the Clinical Trial Management System (CTMS), and assisting with the administration of Quality of Life (QoL) questionnaires under the supervision of the investigator. The coordinator may also conduct interviews with study participants to gather medical history, medications, adverse events, demographics, and quality of life issues, ensuring that all source data is collected accurately and in accordance with medical records. The role also encompasses the preparation and submission of regulatory documents to study sponsors and applicable regulatory agencies, as well as maintaining study and regulatory documentation. The Clinical Research Coordinator II will manage study tasks related to Institutional Review Boards (IRBs) and study sponsors, ensuring ethical conduct and participant safety by applying Good Clinical Practice (GCP) and Human Subjects Protection (HSP) practices. This includes developing safeguards for vulnerable populations and communicating the differences between clinical and research activities to participants. Data management is a critical aspect of this role, requiring the use of Electronic Data Capture (EDC) systems and technologies to ensure accurate data collection and quality assurance. The coordinator will monitor data quality, investigate discrepancies, and ensure compliance with data security protocols. Leadership and professionalism are emphasized, with opportunities for mentoring and training new employees under the guidance of supervisors or senior team members. The Clinical Research Coordinator II will also be involved in site and study management, organizing and managing clinical trials, conducting protocol reviews, and collaborating with investigators to develop recruitment and screening procedures. Effective communication and teamwork are essential, as the coordinator will serve as a liaison between principal investigators, regulatory agencies, and study participants, resolving issues and recognizing the contributions of interdisciplinary team members. Other duties may be assigned as required.