Your browser does not support javascript! Please enable it, otherwise web will not work for you.
« BACK

16253-CRA 2

Undefined
Accountants
Contract Full Time
Melbourne
35 days ago
0
  • 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
    • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
    • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • 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.
    • 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.
    • 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.
    • 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.
    • Collaborate and liaise with study team members for project execution support as appropriate.
    • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
    • If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.

    Qualifications
    • Bachelor's Degree Degree in scientific discipline or health care preferred.
    Requirements
    Requires at least 1 year of on-site monitoring experience.
    • Equivalent combination of education, training and experience may be accepted in lieu of degree.
    • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines).
    • Good therapeutic and protocol knowledge as provided in company training.
    • Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable).
    • Written and verbal communication skills including good command of English language.
    • Organizational and problem-solving skills.
    • Effective time and financial management skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

 

At IQVIA, 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. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

Salary Details*
NameAmount
Salary Type Normal Wages
Base Salary $0
Superannuation 9.5%
Bonus offered No
Total Package $0
* Salary details are calculated without bonus and monthly payout as per tax bracket without tax threshold and other allowances. Its always good to confirm these details with the employer or recruiter.
No Image

Undefined

About Undefined
Skills Required
Visa Requirements
Student Visa
Experience Requirements
Any
Salary Requirements
Normal Wages
Job Type
Contract Full Time
Copyrights © 2021 QWER Pty. Ltd. - All Rights Reserved
ACN: 643 516 241 | ABN: 56 643 516 241