Clinical Trial Associate - #1713519

ARC's purpose is to expedite access to precision medicine clinical trials for patients globally. We fulfil our purpose through our dedicated team of experts with unparalleled domain knowledge, and the important relationships we have developed with our global clients.

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 further support our growing client base and to expedite patient access to life-saving experimental medicines, ARC has developed and launched our SaaS platform, ARC360. ARC360 is transforming how organisations access regulatory intelligence and tailor study-specific information for using in vitro diagnostics to select and manage patients in IND trials. Powered by cutting-edge technologies and supported by a team of regulatory, quality, and clinical operations experts, ARC360 is designed to accelerate the initiation of complex clinical trials.

Job Description

As a Clinical Trial Associate, you will play a pivotal part in overseeing clinical study operations from initiation through closeout, ensuring that all processes adhere to established protocols, regulatory requirements, and industry best practices. Your expertise will not only help maintain rigorous compliance with Good Clinical Practice (GCP) guidelines, relevant Standard Operating Procedures (SOPs) but will also support project team members in conducting high-quality clinical research.

The CTA will be involved in most activities in preparation for study set up, conduct and completing a Clinical study which usually includes:

• Supporting the CSL/CPM and CRA in the coordination and management of day-to-day clinical study activities, including monitoring timelines, budgets, and resource allocations.


• Support the development and maintenance of project plans.


• Arranging & participating in the organization of Study Team Meetings. Taking minutes & distributing.


• Collaborate closely with cross-functional teams including regulatory affairs, testing labs and clinical monitoring.


• Support test site selection, initiation, monitoring, and closeout visits.


• Oversee the preparation, management, and archiving of clinical study documentation, including regulatory submissions, informed consents, and standard operating procedures (SOPs).


• Ensure all clinical study processes fully comply with FDA, IVDR, GCP, ISO20916 and other relevant regulatory frameworks as appropriate.


• Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.


• Support the preparation of protocols, monitoring plans and other essential documentation.


• Set up and maintenance of the Trial Master Files (TMF) or electronic filing systems/ set up of the Investigator Site File (ISF).


• Ensure that databases/ tracking tools are set up and maintained throughout the study.


• Proactively identify, document, and support troubleshoot challenges that may compromise study conduct.


• Supporting client and regulatory audits/inspections.


• Other possible tasks may be assigned as needed.

Essential Criteria

• At least 3 years’ experience in Clinical Research with 3 years’ experience administering clinical studies


• Previous experience of working in Clinical Research or the Pharmaceutical Industry


• Knowledge of the Industry/Clinical trial process and drug development


• Knowledge of ICH GCP


• Experience in setting up and maintaining TMF and ISF in paper and/or electronic e.g Veeva


• 
  Skills & Attributes: Highly organized, detail-oriented, quick learner, proactive, flexible, able to multitask, self-motivated, and capable of working both independently and in a team.


• 
  Communication & Time Management: Excellent communication, influencing, and time management skills; able to work under pressure and meet deadlines.


• 
  IT Proficiency: Strong IT skills, especially in Microsoft Word, Excel, Smartsheet, and PowerPoint

Desirable Criteria

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.


• IVD and CDx experience


• Experience in implementation of an eTMF and supporting processes.


• Experience working with international study sites and a global oversight of clinical studies.


• Familiarity with risk-based monitoring approaches.


• Participation in regulatory and or vendor audits.


• Experience in the use of clinical trial management systems (CTMS), electronic data capture (EDC) systems.

Why Join ARC Regulatory?

• Competitive Salary


• 32 days of annual leave


• Employer pension contributions


• Employee Benefits Program (after probation)


• Hybrid working model (after probation)


• Training budget for professional development


• Office located in Catalyst Belfast – a hub of innovation