CLINICAL RESEARCH REGULATORY COORDINATOR II (2)

University of Alabama at Birmingham

United States

May 30, 2022

Description

CLINICAL RESEARCH REGULATORY COORDINATOR II (2) - (T197121)

Description

Position Summary

The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in Alabama and in the Deep South region. A comprehensive designation also means UAB Medicine patients have access to leading-edge treatments or clinical trials that they may not otherwise have at local community hospitals or smaller cancer centers. For many, an NCI designation can hold the key to survival. On-campus and around Birmingham, the O'Neal Cancer Center is a significant part of our economic powerhouse. The O'Neal Cancer Center powers more than 400 scientists and physician-scientists, cares for 20,000 patients annually, and is home to more than 160 employees, plus all the physicians and clinical staff engaged in cancer patient care. The link to our website is: https: // www. uab.edu/onealcancercenter/

To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms). To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. To draft informed consents. To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). To assist in drafting compliant advertisements. To serve as a resource person or act as a consultant within the area of regulatory expertise.

Annual Pay Range: $47,665 - $77,455

Qualifications

Qualifications

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirements.

Preferred Knowledge/Skills

  • Advanced knowledge in regulations related to clinical trials and retrospective IRBs.
  • Basic knowledge of clinical trials.gov, consenting, and protocol review, and adverse and serious adverse event reporting.
  • Ability to work independently, make decisions, and interact with sponsors, regulatory authorities, and investigators.
  • Ability to communicate effectively with physicians, sponsors, and other collaborators.
  • Primary Location

    : University

    Job Category

    : Clinical Research

    Organization

    : 310008400 Comprehensive Cancer Center

    Employee Status

    : Regular

    Shift: Day/1st Shift

    Similar Jobs

    University of Alabama at Birmingham

    United States Apr 29, 2022

    Add to favorites Read more...

    CLINICAL RESEARCH ADMINISTRATOR I

    The O'Neal Comprehensive Cancer Center is one of 51 NCI-designated comprehensive cancer centers in the United States and is the only one in UAB Medicine patients have access to leading-edge treatments or clinical The O'Neal...

    Columbia University

    United States Apr 30, 2022

    Add to favorites Read more...

    Clinical Research Coordinator

    The primary role of this position is to support clinical research involving The primary role of this position is to support clinical research involving Complete certification requirements for assigned protocols Screen designated schedules or patient...

    University of Alabama at Birmingham

    United States Apr 28, 2022

    Add to favorites Read more...

    CLINICAL RESEARCH COORDINATOR III

    CLINICAL RESEARCH COORDINATOR III - (T195316) The clinical researcher is the medical director of the network), the principal investigator on NIH and VA-funded clinical trials, care including recruitment, screening, scheduling, consenting, conducting To coordinate and...