Clinical Research Associate, Site Management - Italy, Milan

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Clinical Research Associate, Site Management - Italy, Milan

Client: IQVIA

Location: Milan, Italy

Job Category: Other

EU work permit required: Yes

Job Reference: fb1ba0c9937b

Job Views: 10

Posted: 20.02.2025

Expiry Date: 06.04.2025

Job Description:

Job Overview:
Engage in structured training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

Essential Functions:

1. Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
2. Gain experience in study procedures by working with experienced clinical staff.
3. Under close supervision, perform site monitoring visits (selection, initiation, monitoring and close out visits) in accordance with contracted scope of work and good clinical practices.
4. Under close supervision, administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
5. Under close supervision, 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.
6. 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.
7. Under close supervision, 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 Good Clinical Practice (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements.
8. Under close supervision, may support start-up phase.
9. Under close supervision, 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.
10. Collaborate and liaise with study team members for project execution support as appropriate.
11. If applicable, learn key facets for successful development of project subject recruitment plan on a per site basis. Suggest ideas for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment progress.

Qualifications:

1. Bachelor's Degree in scientific discipline or health care preferred. Equivalent combination of education, training and experience may be accepted in lieu of degree.
2. In possession of the local ministerial decree as per Italian requirements.
3. Prior clinical experience preferred. Some organizations may require 2 years of clinical experience.
4. Computer skills including proficiency in Microsoft Word, Excel, PowerPoint, and use of a laptop computer and iPhone/iPad (where applicable).
5. Written and verbal communication skills including good command of the English language.
6. Organizational and problem-solving skills.
7. Effective time and financial management skills.
8. Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
9. Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
10. Knowledge of applicable protocol requirements as provided in company training.

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.