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Clinical Research Associate (CRA II/SCRA), Italy - L

Employer
CROMSOURCE
Location
Italy
Salary
Competitive
Start date
4 Dec 2023
Closing date
3 Jan 2024

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Job Details

Description:

Location: Italy - home based

Schedule: Full-time, Permanent

CROMSOURCE is a growing international CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture, and we are looking for a dynamic person to join our in-house team as a Clinical Research Associate (CRA II). You will be responsible for site management (including start-up), both on-site and remotely across Italy while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies.

You will manage clinical projects to ensure quality, budget, and timelines are met while working on projects from our varied client base, ranging from small to mid-sized pharma, biotech, and medical device companies. The studies you will initially be assigned to will be within Oncology, Respiratory, Medical Device, and Cardiology.

Join our team and help us deliver clinical trials that will improve patients' lives.

Main Job Tasks and Responsibilities:

 

  • Keeps professionally abreast of all scientific, regulatory, and operational aspects relevant to the clinical projects assigned
  • Assists in the selection of sites, site evaluation visits, initiation visits, and ensuring follow-up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
  • May act as Feasibility Associate after appropriate and documented training
  • Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance
  • Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness, and quality of the Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
  • Conducts source data verification and in-house review of clinical data and ensures timely resolution of data queries to guarantee reliable clinical data
  • Manages the investigational products (storage, inventory, dispensing records, packaging, and labeling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc.) to ensure timely and correct supply to the site
  • Cooperates with the site staff for ensuring proper reporting from the site of the safety issues (such as AEs/SAEs, SUSARs, etc.) and their follow-up, guaranteeing timely and appropriate handling of safety issues
  • Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project
  • Will be the main contact person for the site in order to ensure close follow up
  • Provides general support to the Clinical Research Division on quality control of clinical data
  • Promptly address the Projects Coordinators/ Project Managers/ Senior Project Managers about any issues that can jeopardize the conduct of the clinical projects assigned
  • Reports to the Head of Clinical Monitoring Unit on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial
  • Develops training material and gives training in collaboration with the Training & Qualification Management Unit
  • May assist in contract negotiation with sites on study budget after appropriate and documented training
  • Assists the preparation of the study including CRF design/development, writes CRF instructions, and organizes the study files and documents to ensure good start-up of the investigation sites
  • May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training.
  • Guides and supervises Clinical Research Associate I (CRA I) in order to coach and train them on the job

 


Education and Experience:

 

 

  • University Degree in scientific medical or paramedical disciplines
  • Previous proven experience as a CRA, performing on-site monitoring activities
  • Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirements

 


Specific Role Requirements and Skills:

 

 

  • Fluent in English
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel

 


The Benefits of Working in Italy:

 

 

  • Meal vouchers
  • Mobile phone if requested by the Line Manager
  • Dedicated Line Manager
  • Monthly meetings with the line manager
  • Full performance and development process with end-of-year reviews
  • Team events and end-of-year party
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Employee satisfaction survey - your feedback is important for continuous improvement

 


The Application Process

Once you have submitted your CV, you will receive an acknowledgment email. If you have the requirements we need, you will be invited for a phone interview as the first step.

If you would like to discuss the role before applying through the website @ http://www.cromsource.com/careers/job-vacancies please contact mailto:careers@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below-industry average turnover rates.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status, or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Clinical Research Associate, CRA, Site Management, Monitor, Monitoring, Oncology, Respiratory, Medical Device, Cardiology, Travel, Submissions, Ethics, Contract Research Organisation, CRO, Permanent, Pharma, Outsourcing

Skills:

Cardiology, Oncology, Respiratory, Clinical Research Associate, clinical trials, CRO, Medical Devices, Monitoring, Pharma

Location: Italy

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Company

CROMSOURCE is now part of ClinChoice. Learn more about ClinChoice by visiting

ClinChoice

CROMSOURCE, a ClinChoice company, is an ISO-certified international provider of fully outsourced services to the pharmaceutical, biotechnology and medical device industries, specialised in clinical development and flexible resourcing solutions.

CROMSOURCE was founded in 1997 and its successful growth has been built on stability, integrity, and high levels of customer satisfaction. We have grown steadily through offices across all regions of Europe and North America and delivering a comprehensive breadth of services.

Acting through PharmaceuticalMedical Device and Flexible Resourcing Solutions teams, and with a comprehensive portfolio of services, we offer a flexible approach to ensure CROMSOURCE optimally supports the unique needs of each client. This could mean providing regulatory consultancy to a small company at the early stages of a medical device development programme, through to provision of full services to a pharmaceutical company performing an international mega-trial to support registration of their product. Whatever the size and scope of the project, each receives the same level of attention to detail and commitment to delivery of a high quality service within budget and to timelines agreed.

We are experts providing experts and we live by our motto – Advise Agree Deliver. This means we leverage our experience and expertise at the early stages of discussions with our clients to freely advise them on the optimal project plan. We then reach agreement with each client on the scope of service, timelines and budget. CROMSOURCE then commit to deliver those services on time and within budget – according to our End-to-End Guarantee and this commitment to guaranteed delivery is unique in the clinical research environment.

 

 

 

Company info
Website
Telephone
+44 (0) 1786 468990
Location
6-9 The Square
Stockley Park
Hayes
Uxbridge
UB11 1FW
United Kingdom

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