Role: Clinical Research Associate I, II, III and Senior CRA (Full Service or Sponsor-dedicated)
Company: Top Tier CRO
Location: Home-Based (if required some flexibility to work in the office can be offered) / Regional Monitoring OR National Monitoring (if Full Service CRA)
Salary: £33,000 - £50,000 Dependant on the level of Experience
As the successful applicant, you will be working on a Full-Service basis, where you'd work on a mix of protocols and sponsors and perform site management activities over the UK (or Regionalised wherever possible).
Or you can be assigned and dedicated to one sponsor (generally Top 10 Pharmaceutical companies), and report directly to the Sponsor project teams, this way granting you in invaluable direct pharma experience. These positions are generally performed across a regionalised cluster of hospital sites. They stress to only have monitoring done on a local basis, creating a work life balance or you can monitor across the entire UK and Northern Ireland.
Depending on experience responsibilities include:
All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of Clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties All aspects of site and registry management as prescribed in the project plans Organize and make presentations at Investigator Meetings Report, write narratives and follow-up on serious adverse events Review progress of projects and initiate appropriate actions to achieve target objectives You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required Participate in the development of protocols and Case Report Forms as assigned Interact with internal work groups to evaluate needs, resources and timelines
Experience of clinical research monitoring including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment In lieu of the above requirements, candidate's significant previous experience of site management and/or study co-ordinator experience will be considered Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process Good planning, organization and problem solving abilities Good communication and interpersonal skills
· If you are interested in a new opportunity but your experience doesn't fit this role, please email your CV to or call for a confidential discussion about potential opportunities.
NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?
JCW offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.
JCW is a recruitment company operating in the Life Sciences space, with specialist consultants working within the technical and regulatory areas. This includes the following markets;
· Pharmacovigilance/Drug Safety
· Regulatory Affairs
· Quality Assurance
· Quality Control
· Medical information
· Medical Writers
· Clinical trials
· Clinical research
· Project Management
If you are interested in opportunities, but feel this position is not suitable, please feel free to get in touch on or