Lead CRA for Novel Biotech - South East UK

Working within pain management therapies, this role will have involvement in a yet-to-be initiated clinical study set to run across 4 or 5 European companies. You will be co-monitoring through a number of different countries with vendor-based CRAs whilst also having responsibility for UK sites. 

 

Responsibilities:

  • Deliver the project / program according to the quality management plan. Guide CRAs and advise on critical specific study issues.
  • Manage clinical study set-up, maintenance and follow-up study activities through ongoing tracking and review of study progress. Report progress to appropriate clinical management and project management forums.
  • Drive high performance and efficiency of the clinical team through CRA project objectives, the conduct of monitoring visits. Provide performance feedback to management on clinical team members.
  • Conduct qualification, initiation, monitoring, and closeout visits for research sites in compliance with the approved protocol
  • Communication with the medical site staff including coordinators, clinical research physicians and their site staff
  • Verifying adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff

 

 

Requirements:

  • Bachelor’s Degree in allied health fields such as Nursing, Pharmacy, or Health Science
  • Previous clinical trial monitoring experience gained within a CRO or Pharmaceutical company.
  • Solid understanding of ICH-GCP guidelines.
  • On-site monitoring experience is essential.
  • Strong communication skills both written and verbal.
  • Proven experience of building relationships with site staff.

 

This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.

 

To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.

 

Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.

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