Clinical Research Associate

1 settimana fa

Milano, Italia IQVIA A tempo pieno

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
- 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.

**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 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.
- 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.

  • Clinical Research Associate

    4 settimane fa

    Milano, Italia Medpace A tempo pieno

    Join to apply for the Clinical Research Associate role at Medpace Continue with Google Continue with Google Join to apply for the Clinical Research Associate role at Medpace The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a...

  • Clinical Research Associate

    1 settimana fa

    Milano, Italia Altro A tempo pieno

    Join to apply for the Clinical Research Associate role at Medpace Continue with Google Continue with Google Join to apply for the Clinical Research Associate role at Medpace The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making...

  • Clinical Research Associate...

    1 settimana fa

    Milano, Italia Altro A tempo pieno

    Join to apply for the Clinical Research Associate role atMedpaceContinue with Google Continue with GoogleJoin to apply for theClinical Research Associaterole atMedpaceThe Clinical Research Associate position at Medpace offers the unique opportunity to have anexciting careerin the research of drug and medical device development whilemaking a differencein the...

  • Clinical Research Associate

    4 giorni fa

    Milano, Italia Medpace A tempo pieno

    Join to apply for theClinical Research Associaterole atMedpaceContinue with Google Continue with GoogleJoin to apply for theClinical Research Associaterole atMedpaceThe Clinical Research Associate position at Medpace offers the unique opportunity to have anexciting careerin the research of drug and medical device development whilemaking a differencein the...

  • Clinical Research Associate

    2 giorni fa

    Milano, Italia CROMSOURCE A tempo pieno

    **Location**: Italy - home based **Schedule**: Full-Time, Permanent CROMSOURCE is currently recruiting for a **Clinical Research Associate** for an internal position, located in Italy. **Position Duties & Responsibilities**: - Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study...

  • Clinical Research Associate

    1 settimana fa

    Milano, Italia Boston Scientific Corporation A tempo pieno

    **Clinical Research Associate**: - Remote Eligible: Remote in Country- Onsite Location(s): Milan, MI, IT**Additional Locations**: Italy-Milan; Italy-Rome **About The Role**: The Clinical Research Associate (CRA) supports the Global Clinical Operations (GCO) Center of Excellence, conducting activities consistent with GCO’s mission of building a world...

  • Clinical Research Associate

    6 giorni fa

    Milano, Lombardia, Italia ICON plc A tempo pieno

    Clinical Research AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Clinical Research Associate - Cell Therapy...

  • Clinical Research Associate

    4 ore fa

    milano, Italia ICON A tempo pieno

    Clinical Research Associate II ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II to join...

  • Clinical Research Associate

    4 giorni fa

    Milano, Italia Icon A tempo pieno

    Clinical Research Associate IIICON plc is a world-leading healthcare intelligence and clinical research organization.We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Clinical Research Associate II to join our...

  • Clinical Research Associate – Site Monitoring

    3 settimane fa

    Milano, Italia IQVIA A tempo pieno

    A leading global provider of clinical research services is seeking an Entry-level Clinical Research Associate in Milan, Italy. The role involves conducting clinical monitoring visits, managing study processes, and ensuring adherence to regulatory requirements. Candidates should possess a Bachelor's degree in a scientific discipline and have communication...