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Clinical Research Associate II

Employer
Hobson Prior
Location
Italy, Milan (province)
Salary
£31626.35 - £40662.45 per annum
Start date
31 Mar 2021
Closing date
27 Apr 2021

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Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Hobson Prior are currently looking for a Clinical Research Associate II to join a Global CRO in Milan on a permanent basis.


Please note that to be considered for this role you must have the right to work in this location.


Job Responsibilities:

  • You will act as main link with study site personnel, or in partnership with Central Monitoring Associate. Confirms all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • To prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Contributes in global clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.
  • You will execute site qualification, site initiation, interim monitoring, site management activities and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice and protocol compliance.
  • To confirm the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
  • May perform investigational product inventory, reconciliation and reviews storage and security. Confirms the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP.
  • To provide direction at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • You will maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required
  • You will routinely review the Investigator Site File for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File. Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies.
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets.

Requirements:

  • Excellent knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
  • Educated in a Bachelor's degree or RN in a related field or equivalent combination of education, training and experience, at least 2 years of experience as CRA .
  • Excellent computer skills and be able to embrace new technologies.
  • Excellent communication, presentation and interpersonal skills.
  • Ability to travel of up to 75% on a regular basis.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.



Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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