Clinical Study Advisor in Belfast

Location: Belfast

Salary: £ DOE

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We are a Belfast-based Clinical Research Organisation that specialises in delivering compliance excellence for companies in the precision medicine sector. We support many of the world's leading pharmaceutical R&D companies in implementing unapproved diagnostics in their clinical development programmes for patient selection or stratification, working as a strategic and integrated expert partner, taking full sponsor ownership of the IVD study being conducted in parallel with our clients' IND/IMP trial.

ARC's team of experts cover IVD regulatory compliance, study design and approvals, quality assurance including vendor due diligence and management along with a team of clinical research experts who manage the IVD study, ensuring it is conducted in compliance with local and global GCP, and that the biomarker data is robust and reliable.

To be an integral member and Clinical Lead to project team(s) in the development and delivery of ARC's Sponsor Delegation offering to client companies, ensuring that client objectives are met and always exceeded. This will require the utilisation of a platinum standard approach to clinical research project management, internal and external stakeholder satisfaction as well as an innate work ethic that is aligned with the company's core values.

• Study design, strategy, planning (timeline, resources and budget management).
• Coordinating clinical operational activities with internal stakeholders and clients, including pharma company and central testing laboratories conducting the studies.
• Development and/or review of associated documentation including documents such as CPSP, CSP, investigator brochure, informed consent for devices, risk-based monitoring plan and reports, in compliance with relevant regulations, guidelines and SOPs.
• Client management, issue resolution, troubleshooting and ongoing coordination between all relevant groups to maintain compliance to protocol, patient safety and robust data collection and provision of regular updates to project progression.
• Understanding and application of relevant regulatory requirements and ethical approvals for conducting studies (e.g. Managing the study close out activities including, essential documentation filing and completion between study testing site(s) and sponsor TMF, ethical and regulatory bodies notification of study close, study close out report).
• Generation of clinical study reports and related documentation to submit to regulatory authorities, ethical review boards and local agencies such as national competent authority.

Undergraduate degree in biological sciences or other related scientific subject. Other devices or pharmaceutical experience in the capacity of device sponsor will be considered. Demonstrable knowledge of regulatory requirements and industry practices (e.g. Experience of using TMF and/or eTMF and Smartsheet (or equivalent) software. Experience of authoring clinical study documents (e.g. Clinical Strategy, Data Management Plan, CPSP, CSP, Investigator Brochure, Risk-based Monitoring Plan, Informed Consent Documents). Postgraduate degree in biological sciences or other related scientific subject. Prior experience working in a rapid growth, SME environment. Specific experience within oncology, IHC, NGS or molecular CDx.

Benefits: Private Medical, Free Car Parking, Employee Referral Scheme