Senior/Clinical Research Associate

IQVIA RDS PTY. LIMITED; Melbourne; Híbrido; AUD 105.000 - 125.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Car allowance

Health allowance

Hybrid work environment

Descripción de la vacante

IQVIA RDS PTY. LIMITED is seeking (Senior) Clinical Research Associates for permanent, full-time roles across Australia. The positions offer flexible hybrid work with Melbourne and Sydney offices, and sponsorship for eligible candidates.

Responsibilities include on-site monitoring, site management, recruitment tracking, and ensuring compliance with GCP/ICH. Competitive salary with car allowance and superannuation is provided for eligible candidates, with career growth opportunities across trials.

Formación

• Bachelor's Degree in science or health care is required.
• Minimum 9 months of independent on-site monitoring experience.
• Solid knowledge of GCP and ICH guidelines applies.
• Proficiency with Microsoft Word, Excel and PowerPoint.

Responsabilidades

• Perform site monitoring visits following the protocol and regulatory requirements.
• Drive site recruitment plans and maintain regular communication with sites.
• Track regulatory submissions, recruitment, CRF completion and data queries.
• Maintain TMF/ISF and prepare visit reports with action plans.

Conocimientos

GCP & ICH knowledge

Time management

Educación

Bachelor's Degree in scientific discipline or health care

Herramientas

Microsoft Word

Microsoft Excel

PowerPoint

Descripción del empleo

Job Type: Permanent position | Full time position

Job Description

Are you a (Senior) Clinical Research Associate looking for your next big adventure? Look no further than IQVIA, a global CRO with outstanding reputation. Our CRA teams have current openings across various locations in Australia.

*Visa sponsorship for candidates that meet the requirements and eligibility. Only suitable candidates will be contacted. 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 in scientific discipline or health care. Requires at least 9 months of independent 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).

Organizational and problem-solving skills. Effective time and financial management skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

Candidates will be assessed according to their years of experience and be considered for various levels where applicable. What's in it for you? Flexible hybrid work environment, with an office in the heart of Melbourne and Sydney.

Competitive salary with car and health allowances. Career growth and opportunity across our FSO and FSP models. Work with skilled Managers across multi-phases clinical trials

CRA 2: Base AUD$105,000 + Car AUD18,000 + Super SCRA3: Base AUD$125,000 + Car AUD$20,000 + Super