Top Clinical Research Executive jobs in Rhode Island

Top Clinical Research Executive plans and directs all aspects of the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Top Clinical Research Executive ensures adherence to SOPs, Good Clinical Practice and FDA regulations. Requires an advanced degree. Additionally, Top Clinical Research Executive typically reports to top management. The Top Clinical Research Executive manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. To be a Top Clinical Research Executive typically requires 8+ years of managerial experience. Comprehensive knowledge of the overall departmental function. (Copyright 2024 Salary.com)

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Specialist II, Quality Control
  • Velocity Clinical Research, Inc.
  • East Greenwich, RI FULL_TIME
  • Overview

    Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

     

    As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

     

    Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

     

    Job Summary:

    Conduct and manage QC of multiple sites with higher volume and complexity of studies in accordance with Quality Control Plan. Works closely with the clinical research coordinators and site directors to provide feedback on the quality of the source documents.

    Responsibilities

    Duties/Responsibilities:

    • Conduct QC reviews following current QC review processes or guidelines according to the quality control plan.
    • Coordinate and conduct the quality review of source documents to identify protocol deviations, ALCOA-C and GCP/ICH compliance and logic checks.
    • Review DOA log to ensure staff are delegated to the tasks for which they are documenting in the source.
    • Communicate study/regulatory/source documentation deficiencies to Coordinators, investigators, and/or other responsible parties for resolution.
    • Identify compliance and deviation trends across coordinators and/or trials and escalate to Site Leadership, Investigator and Manager of QC.
    • Identify and escalate process gaps in Velocity SOPs to the Manager of QC.
    • Works closely with QC manager to communicate with Site Leadership and Velocity QA regarding any protocol deviations, good documentation practices deficiencies and any identified potential staff training requirements. This role emphasizes individual site trends analysis and thorough review of site-specific source documentation.
    • Communicate effectively and professionally with coworkers, leadership.
    • Perform QC duties while maintaining confidentiality and privacy.
    • Identify/escalate issues regarding breaches of confidentiality of patient protected health information, sponsor confidential information, and/or Velocity confidential information.
    • Comprehend protocol requirements to verify good documentation practices, and completeness of source.
    • Participate in site director quality calls to discuss QC findings.
    • Maintain up-to-date quality reporting and tracking documentation.
    • Act as resource for Quality Control Specialist I as well as serve subject matter expert for coordinators.
    • Other duties as assigned.

    Qualifications

    Required Skills/Abilities:

    • Proficient problem-solving and strategic decision-making abilities.
    • Proficient knowledge of GCP and ICH guidelines.
    • Proficiency in taking individual responsibility for actions and demonstrating professionalism in feedback scenarios.
    • Proficient understanding of medical terminology.
    • Proficiency in utilizing various technologies: Computers, Microsoft Office, CTMS systems, Electronic Data Capture, Electronic Informed Consent systems, Electronic Regulatory Systems, fax, copier, and multi-line telephone.
    • Proficient ability to work in a fast-paced environment.
    • Strong verbal, written, and organizational skills.
    • Strong interpersonal and communication abilities.
    • Ability to work as a team player.
    • Advanced ability to read, write, and speak English.
    • Ability to multi-task.
    • Ability to work independently, plan, and prioritize multiple deliverables and objectives with minimal guidance.
    • Ability to be flexible/adapt as daily schedule may change rapidly.
    • Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised
    • Must be detail-oriented.

    Education and Experience:

    • Bachelor’s degree and minimum of 2 years’ experience as a Clinical Research Coordinator/Clinical Research Associate OR
    • Associate’s degree and a minimum of 4 years’ experience as a Clinical Research Coordinator/Clinical Research Associate OR
    • High School Graduate and/or technical degree and 6 years as a Clinical Research Coordinator/Clinical Research Associate

    Required Licenses/Certifications:

    • CCRC, CCRP, CCRA certification through ACRP or SOCRA, strongly encouraged.

    Physical Requirements:

    • Prolonged periods of sitting at a desk and working on a computer.
    • Must be able to lift up to 15 pounds at times.

     

    NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required.  Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change.  All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

  • 1 Month Ago

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Clinical Research Assistant
  • Rhode Island Hospital
  • Providence, RI FULL_TIME
  • Summary: Under the general supervision of the Principal Investigator(s) and Clinical Research Coordinator assist in acquisition and analysis of patient information for multiple clinical research proje...
  • 3 Days Ago

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Clinical Research Prgm Coord
  • Rhode Island Hospital
  • Providence, RI FULL_TIME
  • Summary: Reporting to the Principal Investigator(s) and in accordance with established policies and procedures the incumbent is responsible for the operation of research programs including recruitment...
  • 4 Days Ago

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Clinical Research Assistant
  • University Gastroenterology LLC
  • Providence, RI FULL_TIME
  • DescriptionResponsibilities/Duties/Functions/Tasks:• Assists the Study Team, as needed in communication of study requirements to all individuals involved in the study. • Works with the Study Team, as ...
  • 11 Days Ago

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Clinical Research Coordinator II
  • University Gastroenterology LLC
  • Providence, RI FULL_TIME
  • DescriptionResponsibilities/Duties/Functions/Tasks:· Regular communication of study requirements and changes to relevant members of study staff. Implements recruitment strategies to prescreen, screen,...
  • 13 Days Ago

Rhode Island (/ˌroʊd -/ (listen)), officially the State of Rhode Island and Providence Plantations, is a state in the New England region of the United States. It is the smallest state in area, the seventh least populous, the second most densely populated, and it has the longest official name of any state. Rhode Island is bordered by Connecticut to the west, Massachusetts to the north and east, and the Atlantic Ocean to the south via Rhode Island Sound and Block Island Sound. It also shares a small maritime border with New York. Providence is the state capital and most populous city in Rhode Is...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Clinical Research Executive jobs
$220,197 to $401,876