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Research Coordinator II - Heart and Vascular

Research Coordinator II - Heart and Vascular

Dartmouth HealthLebanon, NH, US
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Overview

Clinical Research Coordinator II performs a full range of clinical research duties at a skilled level and has a working knowledge of the clinical research process and the regulations that govern it. The expectation is to perform progressively more complex and comprehensive clinical research duties with an increasing level of independence, working closely with the Principal Investigator (PI). The Clinical Research Coordinator II works under the supervision of and at the direction of the PI or their designee. They cannot perform any tasks that state or local law require a license to perform.

Responsibilities

  • Research Operations – Occasionally requiring tasks outside of defined operating hours
  • Arrange and / or schedule required tests and other appointments
  • Understand and support all aspects of study operations (including subject management / regulatory) with oversight from the investigator or their designee
  • Primarily support subject management, such as data entry in the Clinical Trial Management System (CTMS), scanning informed consents into EMR, and supporting data entry needs of the study
  • Carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision of investigator
  • Interview study participants about medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by PI, with collection of source data directly informed by medical records
  • Communicate with participants throughout the course of the study
  • Provide education and support to study participants and their families
  • Prepare and submit regulatory documents to study sponsors and applicable regulatory agencies
  • Maintain study and regulatory documentation
  • Manage study tasks primarily related to working with Institutional Review Boards (IRBs) and study sponsors as well as Dartmouth-Hitchcock Medical Center (DHMC) regulatory committees

Ethics & Participant Safety

  • Apply and implement Good Clinical Practice (GCP) / Human Subjects Protection (HSP) practices
  • Maintain familiarity with the ethical conduct of research and safeguards needed when conducting research
  • Assist in the design of studies to include specific safeguards to ensure ethical conduct and protect vulnerable populations
  • Develop or assist with development of documents related to safety and security
  • Communicate with research participants regarding the difference between clinical activities and research activities, and the risks and benefits of study participation

    • Data and Informatics

  • Utilize Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations
  • Score tests, enter data, and complete Case Report Forms (CRFs, eCRFs) accurately and according to protocol
  • Develop or assist with data collection documents and instruments and procedures for data quality assurance
  • Monitor for and identify potential issues related to data capture, collection or management and suggest solutions; investigate incomplete, inaccurate or missing data
  • Adhere to processes and run queries, summaries and reports to monitor data quality
  • May be responsible for recognizing trends related to data quality and escalating as appropriate
  • Use required processes, policies and systems to ensure data security

    • Leadership and Professionalism

  • Understand and employ professional guidelines and code of ethics related to the conduct of clinical research and Dartmouth-Hitchcock (D-H) and project-specific training requirements
  • May travel to investigator meetings or protocol-specific training
  • May participate in new employee mentoring / training under the guidance of a supervisor or senior team member

    • Site and Study Management

  • Organizes and manages clinical trials and research studies
  • Conducts protocol reviews to assess feasibility and seeks out new research opportunities
  • Participates in study site selection activities
  • Collaborates with study investigators to develop recruitment and screening procedures
  • Designs and develops recruitment documentation
  • Composes informed consent forms and protocol abstracts
  • Maintains other study documents and study management tools
  • May participate in manuscript / abstract development

    • Communication and Team Science

  • Serves as a liaison between principal investigators, regulatory agencies, Dartmouth-Hitchcock stakeholders and study participants to resolve problems
  • Identifies and recognizes the respective roles of team members
  • Understands and upholds the importance of an interdisciplinary team and the value each member brings to clinical studies
  • Performs other duties as required or assigned

    • Qualifications

  • Bachelor's degree and 2 years of relevant research experience OR equivalent years of experience
  • Ability to travel as required
  • SOCRA / ACRP Certification or eligible for certification preferred

    • Required Licensure / Certifications

  • BLS certification within 30 days of hire date
  • Human Subjects Protection (HSP) within 30 days
  • Certified Good Clinical Practice (CGCP) within 30 days
  • Area of Interest : Research / Science
  • Pay Range : $46,321.60 / Yr. - $71,780.80 / Yr. (Based on 40 hours per week, otherwise pro rata)
  • FTE / Hours per pay period : 1.00
  • Shift : Day
  • Job ID : 34136

    • Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans. Click here for information on these benefits and more : Benefits | DHMC and Clinics Careers

    Dartmouth Health is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dartmouth Hitchcock Medical Center and Dartmouth Hitchcock Clinics comply with applicable Federal civil rights laws and do not discriminate on the basis of race, color, national origin, age, disability, or sex.

    Seniority level

  • Entry level

    • Employment type

  • Part-time

    • Job function

  • Information Technology

    • Industries

  • IT Services and IT Consulting

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    Location : Lebanon, NH

    Salary : $58,600.00-$73,200.00

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    Research Coordinator • Lebanon, NH, US