Freelance Senior Clinical Research Associate

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

ClinChoice is searching for a Freelance Clinical Research Associate to join one of our partner companies, a large pharmaceutical company leader in the field of medical devices. This would be for initially 2 years, for approximately 0.2 FTE. 

The ideal candidate will have a strong background as a CRA, ideally with medical device and cardiology studies, and experience with submissions in Italy.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts. 

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.
• Support with local Ethics Committee submissions for assigned studies, including Patient Informed Consent. 
• 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 labelling) 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.
• You 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.

Education and Experience:

• University Degree in scientific medical or paramedical disciplines.
• Previous proven experience as a CRA, performing on-site monitoring activities.
• Experience with Italian ethics committee submissions. 
• Strong knowledge of clinical trial operations, GCP/ICH Guidelines, and other applicable regulatory requirement.
• Fluent in English and Italian
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
• Willingness to travel

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice    

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.           

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice 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 to 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.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Keywords: Freelance Clinical Research Associate, Freelance CRA, Site Management, Monitor, Monitoring, Medical Devices, Travel, Submissions, Ethics, Contract Research Organisation, CRO.

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