Clinical Research Director jobs in Providence, RI

Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (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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Senior Clinical Research Associate
  • TFS HealthScience
  • Copenhagen, NY FULL_TIME
  • Overview TFS HealthScience is excited to be expanding our Strategic Resourcing Solutions (SRS) team and we are looking for an experienced, highly motivated Senior CRA who shares our vision of providin...
  • 20 Days 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...
  • 2 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...
  • 3 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 ...
  • 10 Days Ago

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0 Clinical Research Director jobs found in Providence, RI area

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Advanced Practice Mgr Pediatric
  • Rhode Island Hospital
  • Providence, RI
  • This position will supportPedi Hasbro 5 & The Tomorrow Fund. Summary: The Advanced Program Manager (APM) reports to the ...
  • 3/28/2024 12:00:00 AM

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Advanced Practice Mgr
  • Rhode Island Hospital
  • Providence, RI
  • This position will support theVascular Access Team. Summary: The Advanced Program Manager (APM) reports to the Director ...
  • 3/28/2024 12:00:00 AM

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Clinical Manager Critical Care
  • The Miriam Hospital
  • Providence, RI
  • Summary: The Clinical Manager reporting to the department director is responsible for translating and supporting the goa...
  • 3/28/2024 12:00:00 AM

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Critical Care Paramedic
  • Lifespan Corporation
  • Providence, RI
  • Summary: Under supervision of the Medical Director and the Lifeguard EMS Program Coordinator following established polic...
  • 3/28/2024 12:00:00 AM

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President & COO
  • VNA of Care New England
  • Warwick, RI
  • Job Summary: The President & Chief Operations Officer, VNA of CNE is responsible for the smooth, effective, and efficien...
  • 3/27/2024 12:00:00 AM

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Manager, QARC Clinical Trial / Data Management
  • UMass Med School
  • Lincoln, RI
  • Manager, QARC Clinical Trial / Data Management Minimum Salary US-RI-Lincoln Job Location 2 days ago(3/24/2024 12:14 PM) ...
  • 3/27/2024 12:00:00 AM

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Senior Country Clinical Quality Management Lead (Remote)
  • Careerbuilder
  • Providence, RI
  • Merck Senior Country Clinical Quality Management Lead (Remote) Providence , Rhode Island Apply Now It is critical that, ...
  • 3/25/2024 12:00:00 AM

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Director, Quantitative Pharmacology and Pharmacometrics Immune/Oncology (Remote)
  • Careerbuilder
  • Providence, RI
  • Merck Director, Quantitative Pharmacology and Pharmacometrics Immune/Oncology (Remote) Providence , Rhode Island Apply N...
  • 3/25/2024 12:00:00 AM

The Providence city limits enclose a small geographical region with a total area of 20.5 square miles (53 km2); 18.5 square miles (48 km2) of it is land and the remaining 2.1 square miles (5.4 km2) is water (roughly 10%). Providence is located at the head of Narragansett Bay, with the Providence River running into the bay through the center of the city, formed by the confluence of the Moshassuck and Woonasquatucket Rivers. The Waterplace Park amphitheater and riverwalks line the river's banks through downtown. Providence is one of many cities claimed to be founded on seven hills like Rome. The...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Director jobs
$150,054 to $202,569
Providence, Rhode Island area prices
were up 1.6% from a year ago

Clinical Research Director in Killeen, TX
We are Looking for an Assistant Director for the Center for Clinical Research Education.
December 07, 2019
Clinical Research Director in Springfield, IL
During the Clinical Research Operations Forum a few weeks ago, Stephen Sonstein, Ph.D., Professor & Program Director for Clinical Research Administration at Eastern Michigan University spoke on the shift in clinical research going from a focus on regulatory compliance to a standardization of competencies for professionals working in the field.
February 06, 2020
Clinical Research Director in Olympia, WA
You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator in the NHS or as a clinical trials administrator.
January 28, 2020