Research Coordinator III - Neurology jobs in United States
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Dartmouth Health · 1 week ago

Research Coordinator III - Neurology

Dartmouth Health is seeking an experienced Clinical Research Coordinator III in the Department of Neurology to manage clinical trials. This role involves overseeing study operations, ensuring regulatory compliance, and mentoring new staff while maintaining high standards in clinical research practices.

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Responsibilities

Mentors, onboards, trains and oversees new clinical research coordinator staff on Good Clinical Practice (GCP), Human Subjects Protection (HSP) practices, the ethical conduct of research and a full range of clinical research duties including regulatory compliance
May arrange/schedule required tests and other appointments
Independently executes all aspects of the study operations (subject management/regulatory) with minimal oversight from the investigator or their designee
Oversees subject management, such as data entry in Clinical Trials Management System (CTMS), scanning informed consents into Electronic Medical Records (EMR), and supporting data entry needs of the study
May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision by investigator
May interview study participants about their medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by principal investigator with collection of source data directly informed by medical records
May communicate with participants throughout the course of the study
May provide education and support to study participants and their families
Prepares and submits regulatory documents to study sponsors and any applicable regulatory agencies
May maintain study and regulatory documentation including working with the Institutional Review Board (IRB), ensuring all staff involved in the study are trained and that the training is appropriately documented
Supports the evaluation of staff and assure compliance with GCP,HSP practices and the ethical conduct of research
Assists and facilitates the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations
Assists and facilitates with the development of documents related to safety and security
Communicates to research participants the difference between clinical activities and research activities and the risks and benefits of study participation
Trains others on the proper utilization of Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations
Scores tests, enters data and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol
Develops and implements data collection documents and instruments
Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data
Designs, develops or assists with development of Standard Operating Procedures (SOPs) for data quality assurance
Adheres to processes and runs queries, summaries and reports to monitor the quality of data
Monitors for and detects issues related to data capture, collection or management and suggests solutions
Recognizes trends related to data quality and escalates as appropriate
Uses required processes, policies and systems to ensure data security
Understands and employs the professional guidelines and code of ethics related to the conduct of clinical research and D-H and project specific training requirements
Travels to investigator meetings and study training sites
Provides guidance, oversight and mentoring to team members in skills and in performance expectations of service excellence, teamwork, communication, dependability and professionalism
Independently organizes and manages clinical trials and research studies
Conducts protocol reviews to assess the feasibility of potential studies
Participates in study site selection activities
Designs, develops and recommends recruitment and screening procedures and documentation
Composes informed consent forms and protocol abstracts
May participate in manuscript/abstract development
Maintains other study documents and study management tools
Provides expertise and guidance to the research team and investigators
Participates in the preparation of grants or study budgets for funding department research
Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems
Supports and provides guidance to other members of the research team

Qualification

Clinical Research CoordinationClinical Practice (GCP)Human Subjects Protection (HSP)Electronic Data Capture (EDC)Certified Clinical Research Coordinator (CCRC)Certified Clinical Research Associate (CCRA)Certified Clinical Research Professional (CCRP)Data Quality AssuranceLeadershipCommunicationTeamworkMentoring

Required

Bachelors or equivalent years of experience
4 years of relevant research experience
Ability to travel as required
BLS required within 30 days of hire date
Certified Clinical Research Coordinator (CCRC-ACRP) or Certified Clinical Research Associate (CCRA) or Certified Clinical Research Professional (CCRP-SCRA)
Certified Good Clinical Practice (CGCP) within 30 days
Human Subjects Protection (HSP) within 30 days

Preferred

Masters in relevant field

Company

Dartmouth Health

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Dartmouth Health is a highly integrated, cohesive healthcare system grounded in outstanding medical expertise.

Funding

Current Stage
Late Stage

Leadership Team

K
Kenneth J. Kelliher
Vice President, Supply Chain Division
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