Italy Job Openings
IQVIA
Clinical Research Associate, Site Management - Italy
FULL TIME
September 5, 2024
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.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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
- Complete appropriate therapeutic, protocol and clinical research training to perform job duties.
- Gain experience in study procedures by working with experienced clinical staff.
- 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.
- Under close supervision, administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
- 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.
- 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.
- 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.
- Under close supervision may support start-up phase.
- 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.
- Collaborate and liaise with study team members for project execution support as appropriate.
- 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
- Bachelor's Degree Degree in scientific discipline or health care preferred. Req
- Equivalent combination of education, training and experience may be accepted in lieu of degree.
- In possess of the local ministerial decree as per Italian requirements.
- Prior clinical experience preferred.
- Some organizations may require 2 years of clinical experience.
- Computer skills including proficiency in use of Microsoft Word, Excel and Power Point and use of a laptop computer and i Phone and i Pad (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.
- Advanced knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Knowledge of applicable protocol requirements as provided in company training.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
New Job Alerts
Amplifon Group
Italy IT Project Management Internship
FULL TIME
September 22, 2024
View Job DescriptionNestle Operational Services Worldwide SA
IT - Junior Risk & Compliance Specialist
Assago
FULL TIME
September 21, 2024
View Job DescriptionLooking for similar job?
IQVIA
Clinical Research Associate, Sponsor Dedicated - Italy
FULL TIME
August 22, 2024
View Job DescriptionBoston Scientific Corporation
Field Clinical Specialist, Vascular Peripheral Interventions (based in Italy)
FULL TIME
August 9, 2024
View Job DescriptionBoston Scientific Corporation
Field Clinical Specialist, EP (based in Marche)
Bologna
August 9, 2024
View Job DescriptionOspedale San Raffaele srl
Junior Technician position Cell Therapy in TIGET Clinical Lab
August 1, 2024
View Job DescriptionSee What’s New: IQVIA Job Opportunities
IQVIA
Global Site Activation Manager, South Africa
FULL TIME
September 12, 2024
View Job DescriptionNew Job Alerts
Amplifon Group
Italy IT Project Management Internship
FULL TIME
September 22, 2024
View Job DescriptionNestle Operational Services Worldwide SA
IT - Junior Risk & Compliance Specialist
Assago
FULL TIME
September 21, 2024
View Job Description