CLINICAL RESEARCH REGULATORY COORDINATOR II (3)

University of Alabama at Birmingham

United States

November 9, 2021

Description

CLINICAL RESEARCH REGULATORY COORDINATOR II (3) - (T190889)

Description

About O'Neal Comprehensive Cancer Center

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

Position Summary

Prepares, submits, and assists with multiple levels of research documentation, IRB submissions to UAB, WIRB, Advarra, and others. Maintains regulatory documentation including ICF, protocol, 1572, CV's, ML, IB, recruitment materials, submission forms, drafts informed consents. Maintains/prepares FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs). Serve as resource person or act as consultant within area of regulatory expertise.

Primary Duties and Responsibilities

  • Prepares, submits, and assists with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms)
  • Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms
  • Drafts informed consents
  • Prepares and maintains FDA applications for INDs and IDEs
  • Assists in drafting compliant advertisements
  • Makes and assists in modifying protocols and study documents
  • Completes and submits safety Reports and government documents as needed
  • Enters protocol-specific data into required institutional systems (IRAP and OnCore)
  • Maintains appropriate licensure for clinicians
  • Conducts internal quality assurance audits of regulatory files
  • Oversees the maintenance of Delegation of Authority logs
  • Maintain study's compliance with institutional requirements
  • Assists colleagues in identifying efficiencies and improving processes
  • Attends departmental meetings, training and educational opportunities
  • Performs other duties as assigned
  • Annual Salary Range: $45,395 - $73,770

    Qualifications

    Qualifications

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

    Preferred Knowledge, Skills, and Abilities

  • Advanced knowledge in regulatory related to clinical trials and retrospective IRBs
  • Basic knowledge of clinical trials.gov, consenting, and protocol review, adverse and serious adverse event reporting
  • Ability to work independently, to make decisions, to 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