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.
Who will you be working for?
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
Cardiology, Oncology, Respiratory, Clinical Research Associate, clinical trials, CRO, Medical Devices, Monitoring, Pharma