Dartmouth Hitchcock Medical Center and Clinics

Research Coordinator III - Clinical Research Units

Dartmouth Hitchcock Medical Center and Clinics  •  Lebanon, NH (Onsite)  •  4 days ago
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Job Description

The Clinical Research Coordinator III performs a full range of clinical research duties at an advanced level and plans, organizes, leads, and performs comprehensive clinical trial duties for multiple or complex clinical trials, focusing on the overall productivity and success of the program. The expectation is to perform with limited supervision and actively participate in decisions regarding the clinical research process, often leading teams. The impact of decisions of the Clinical Research Coordinator III are wide in scope affecting both internal and external partners. They cannot perform any tasks that by state or local law require a license to perform.

Responsibilities

Research Operations - Occasionally requiring tasks outside of defined operating hours:

  • 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.

    • Ethics & Participant Safety

  • 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.

    • Data and Informatics

  • 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.

    • Leadership and Professionalism

  • 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.

    • Site and Study Management

  • 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.

    • Communication and Team Science

  • 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.
  • Portfolio and Program Development & Management

    • Qualifications

    • Bachelors or equivalent years of experience
    • Masters in relevant field preferred
    • 4 years of relevant research experience
    • Ability to travel as required

    Required Licensure/Certifications

    • BLS required within 30 days of hire date
    • Certified Clinical Research Coordinator (CCRC-ACRP) or Certified Clinical Research Associate (CCRA) or Certified Clinicial Research Professional (CCRP-SCRA)
    • Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.
    Dartmouth Hitchcock Medical Center and Clinics

    About Dartmouth Hitchcock Medical Center and Clinics

    How can the lifestyle in New Hampshire and Vermont compliment your career? You can have amazing 4-season living with a career at one of the top health systems in the country. The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. Anchored by the academic Dartmouth-Hitchcock Medical Center in Lebanon, NH, the system includes the NCI-designated Norris Cotton Cancer Center, the Children's Hospital at Dartmouth-Hitchcock; 4 affiliated hospitals and 30 Dartmouth-Hitchcock ambulatory clinics across the region. We are close to the urban centers of Boston, New York and Montreal, but also offer proximity to the seacoast and multiple top-tier ski mountains within a short driving distance. Throughout New Hampshire, the opportunities – both career and personal – truly make our area the ideal place to work and play.

    Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, veteran status, or any other characteristic protected by law.

    Industry
    Healthcare & Social Services
    Company Size
    5,001-10,000 employees
    Headquarters
    Lebanon, New Hampshire
    Year Founded
    Unknown
    Website
    dartmouth-hitchcock.org
    Social Media