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Clinical Research Associate - Sponsor Dedicated

Company

IQVIA
Address , Remote
Employment type FULL_TIME
Salary
Expires 2023-09-12
Posted at 9 months ago
Job Description

Job Overview
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions
  • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Qualifications

  • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements.
  • Successful completion of a CRA Trainee Program or at least three months of on-site monitoring experience. 2 years of clinical research coordinator experience strongly preferred.
  • Alternatively, you should have an equivalent combination of education, training and experience
  • Good therapeutic and protocol knowledge as provided in company training.
  • Effective time and financial management skills.
  • Organizational and problem-solving skills.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
  • A Bachelor's degree in a health care or other scientific discipline or educational equivalent
  • I.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Written and verbal communication skills including good command of English language.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

As the COVID-19 virus continues to evolve, IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status