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Study Startup Regulatory Specialist (R1083925)

Posted: 2019-06-12

Industry
Hospitals/Healthcare/Diagnostics
Function
IT
Role
Software Engineer/ Programmer
Posted On
12th Jun 2019
Job Ref code
J3V58J6ZQXN3NHJM5QX
Job Description


Job Description

IQVIA is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
BASIC FUNCTIONS:
To provide regulatory support to clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
  • Complete adaptations of Informed Consent Forms (ICFs) with appropriate internal team.
  • Perform other related duties as assigned that may include:
    • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects including essential regulatory document reviews for site initiation visits.
    • Complete debarment checks for principal Investigators and sub investigators as directed by the Study Start Up team.
    • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.

KNOWLEDGE, SKILLS AND ABILITIES:
  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
  • Need a Candidate with Clinical Trials Experience of at least 1 year. Equivalent education/degree and skill in the same domain would be preferable.
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
  • Knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
  • Ability to read and synthe technical material and to prepare clear and concise written documents.
  • Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:
  • Requires Bachelor's degree with at least 3 years of related work experience, science degree preferred or equivalent level of education and work experience.
  • One or more years of work experience in areas relevant to regulatory affairs, quality assurance, and clinical research.
  • Good analytical and communication skills, particularly writing skills, are essential.
  • Demonstrated computer literacy is required.

Join Us
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1083925

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