Cambridge, Cambridgeshire, East Anglia, England
|Posted:||49 days ago|
|Location:||Cambridge, Cambridgeshire, East Anglia, England|
|Salary:||£600 - £640 per day|
Xplore Life Sciences are recruiting an experienced Clinical Study Advisor to work for a top-tier Pharmaceutical company based in Cambridge, UK.
This is a freelance contract role with a minimum of 6 months duration and is likely to extend.
The role is classed as INSIDE IR35 and will be paid PAYE to the candidate.
Remote working is possible with occasional visits to the Cambridge site.
The ideal candidate will have specialist knowledge in clinical trials and participant informed consent. The aim of this initiative is to analyse up to two million genomes by 2026.
The samples HBS sequenced for this initiative include genomic samples collected on clinical trials. Participants have the opportunity to opt in and donate samples for broad, scientific health-related research. This genomic and paired clinical data, along with vast datasets from external collaborations and consortia, enables the CGR to investigate the underlying causes of disease and integrate this knowledge across the drug discovery and development pipeline. This work is fundamental to driving the discovery of unprecedented targets and precision medicine strategies.
In this role you will play an integral part in ensuring that clinical study teams include all documentation required to support the compliant collection of genomic samples and subsequent data generation. You will work closely with the Genomics Clinical Science Adviser to learn about country and site level requirements that may inhibit the collection of this sample. You will also manage a busy query management system, fielding questions direct from study teams and other key stakeholders.
You will also be responsible for using internal systems to survey which clinical studies are being set up and are eligible to collect the genomic sample. You will review clinical study supporting ethics and protocol documentation to ensure the genomic sample is consistently and compliantly represented.
Key activities include:
- Ensure clinical study teams' compliantly use of participant Informed Consent Forms (ICF) and Clinical Study Protocols (CSP) associated with the collection of the optional genomics sample
- Independently handle a ticketing system, triaging and answering questions from study teams and other key stakeholders
- Independently track and record clinical trial progress from across the company, identifying trials eligible for inclusion of the genomics sample
- Proactively review ICF and CSP to check for compliant language
- Contribute to internal communications campaigns to ensure continued understanding of the genomics sample across the company
- Lead/contribute to ad hoc projects across P&O where required
- Degree or equivalent experience in relevant subject
- Good Clinical Practice (GCP) training or equivalent experience
- Experience and specialist knowledge in clinical trials operations and supporting documentation document preparation
- In-depth understanding of ICF language
- Work well within a small team and matrix management environment
- Highly competent in MS software, including Access
- Strong stakeholder management with a collaborative approach
- Excellent organisation skills, attention to detail, and written and oral communication skills
- PhD or equivalent experience in a relevant subject
- Understanding of clinical trial ethics approval process
- Scientific background in HBS, genetics and genetic analysis