Clinical Research Associate, Site Management

4 settimane fa


Roma, Italia IQVIA LLC A tempo pieno

Clinical Research Associate, Site Management - Italy page is loaded Clinical Research Associate, Site Management - Italy Apply locations Milan, Italy time type Full time posted on Posted Yesterday job requisition id R1415148 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.
  • 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 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.
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. Learn more at Similar Jobs (1) Experienced Clinical Research Associate, Site Management - Italy locations Milan, Italy time type Full time posted on Posted 2 Days Ago #J-18808-Ljbffr

  • Roma, Lazio, Italia MSD A tempo pieno

    The Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...


  • Roma, Lazio, Italia MSD A tempo pieno

    The Clinical Research Associate RoleThe role of Clinical Research Associate involves overseeing the performance and compliance of assigned protocols and sites in a country. Under the guidance of the CRA manager, the individual ensures study conduct compliance with ICH/GCP, country regulations, Company policies, quality standards, and adverse event reporting...


  • Roma, Italia EastHORN Clinical Services A tempo pieno

    **Job summary**: As a **Clinical Research Associate **you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties....


  • Roma, Italia MSD A tempo pieno

    **Job Description**: The role of **Clinical Research Associate** is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event...


  • Roma, Lazio, Italia MSD A tempo pieno

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...


  • Roma, Lazio, Italia MSD A tempo pieno

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...


  • Roma, Italia MSD A tempo pieno

    Job DescriptionWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a...


  • Roma, Italia MSD A tempo pieno

    With support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. - Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. - Performs clinical study site management/monitoring...


  • Roma, Italia MSD A tempo pieno

    We aspire to be the premier research-intensive biopharmaceutical company in the world. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and...


  • Roma, Italia TFS HealthScience A tempo pieno

    Overview: TFS HealthScience is excited to be expanding our **Strategic Resourcing Solutions (SRS) **team and we are looking for an experienced, highly motivated **Clinical Research Associate** who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry...


  • Roma, Italia Cmed A tempo pieno

    The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, UK, US, Belgium, Czech Republic, Switzerland, Denmark, Romania, and India. The CRO occupies a unique position in the clinical...


  • Roma, Italia ABBVIE A tempo pieno

    For our Commercial offices, based in Rome, we are looking for a Clinical Research Associate II, with following responsibilities: - Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations,...


  • Roma, Italia MSD A tempo pieno

    **Job Description**: The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company’s policies and procedures, quality standards and adverse event reporting requirements...


  • Roma, Italia MSD A tempo pieno

    **The role of **Clinical Research Associate** is accountable for performance and compliance for assigned protocols and sites in a country.**: **Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our Company policies and procedures, quality standards and adverse event reporting...


  • Roma, Lazio, Italia MSD A tempo pieno

    Job DescriptionWe aim to establish ourselves as the leading research-focused pharmaceutical company globally. Our dedication to improving healthcare accessibility is evident through our extensive policies, programs, and partnerships. At the forefront of combating diseases that affect both humans and animals, including cancer, HIV, Ebola, and emerging animal...


  • Roma, Italia Sitero LLC A tempo pieno

    Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our...


  • Roma, Italia ICON plc A tempo pieno

    At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Integrity, Collaboration, Agility...


  • Roma, Italia TFS HealthScience A tempo pieno

    Overview: TFS HealthScience is excited to be expanding our SRS team and we are looking for an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence. Our SRS team is a highly experienced international group of professionals led by an industry expert. We are a leading global mid-size Contract...


  • Roma, Italia MSD A tempo pieno

    **Job Description**: We aspire to be the premier research-intensive biopharmaceutical company in the world. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs, and partnerships. Today, we continue to be at the forefront of research to prevent and treat diseases that...


  • Roma, Italia Merck Sharp & Dohme (MSD) A tempo pieno

    Job DescriptionWith support of SrCRA/CRA and/or CRA Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites. Develops strong site relationships and ensures continuity of site relationships through all phases of the trial. Performs clinical study site...