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CRA

Employer
Hobson Prior
Location
Hertfordshire, Hemel Hempstead, England
Salary
GBP45000 - GBP55000 per annum
Start date
18 Oct 2021
Closing date
16 Nov 2021

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Job Details

Hobson Prior are seeking a CRA to join a medical devices organisation who are focused on transforming the lives through innovative medical solutions. This role is on a permanent basis and located in London.

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

Key Responsibilities:

  • Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites.
  • Manage multiple sets of essential regulatory documents across several studies and division portfolios.
  • Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF).
  • Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies.
  • Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives.
  • Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking.
  • Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals.
  • Develop, prepare, complete and track required regulatory, ICF and legal documentation.
  • Document clinical research site and investigator readiness for participation across multiple studies.
  • Support internal quality audits, regulatory inspections, as applicable.
  • Update and maintain study-specific start-up trackers.
  • Update and maintain site specific start-up metrics in Clinical Trial Management Systems File and maintain site start up documents in eTMFs.
  • Provide updates to leadership on site start up activities, investigator readiness, regulatory submission and approval status, etc.
  • Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate.
  • Ensure compliance with appropriate regulatory (ICH/GCP, CA, EC, etc.) and internal SOPs/WI, policies & procedures.

Key Skills:

  • Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment.
  • Ability to work in a team environment and possess clear, concise communication & presentation skills.

Requirements:

  • Educated in a Bachelor's Degree, or an equivalent combination of experience and education.
  • Previous experienced in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within assigned geographies.
  • Confirmed ability to establish credibility internally and externally by commanding knowledge of informed consent requirements.
  • Previous experience working with investigational review boards.
  • Experience working with clinical trial management systems and clinical document control systems / eTMF.

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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