Clinical Research Associate, Site Management - Italy
Job Title: Clinical Research Associate, Site Management - Italy
Job Location: Milan, Italy
Job Location Type: Home-based
Job Contract Type: Full time
Job Seniority Level:
Job reputed company Engage in reputed company training program to reputed company knowledge and skills required to independently conduct clinical monitoring reputed company in accordance with study protocol, reputed company operating procedures, good clinical reputed company, and applicable regulatory requirements.
Essential Functions • Complete appropriate therapeutic, protocol and clinical research training to reputed company job duties. • reputed company experience in study procedures by working with reputed company clinical staff. • Under reputed company supervision, reputed company site monitoring reputed company (selection, initiation, monitoring and reputed company out reputed company) in accordance with contracted scope of work and good clinical practices. • Under reputed company supervision, administer protocol and reputed company study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. • Under reputed company supervision, evaluate the reputed company and reputed company of study site practices reputed company to the reputed company conduct of the protocol and adherence to applicable regulations. Escalate reputed company issues as appropriate. • Manage the reputed company of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report reputed company (CRF) completion and submission, and data query reputed company and reputed company. • Under reputed company 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 reputed company (GCP) / International Conference on Harmonization (ICH) and local regulatory requirements. • Under reputed company supervision may support start-up phase. • Under reputed company supervision, create and maintain appropriate documentation regarding site management, monitoring visit findings and reputed company 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 reputed company. Suggest reputed company for improving site recruitment plan in line with project needs to enhance predictability. Assist in tracking subject site recruitment reputed company.
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 reputed company Word, reputed company and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). • Written and verbal communication skills including good reputed company 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 reputed company (GCP) and International Conference on Harmonization (ICH) guidelines. • Knowledge of applicable protocol requirements as provided in company training.
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
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Originally posted on Himalayas
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