Study Monitor Clinical Operations
Swansea
The Recruitment Co are recruiting for a Study Monitor (Clinical Operations) to join our clients expanding team. A world-leading manufacturer of high-quality technical products.
Contract: Permanent
Salary: £28,017pa
Shifts: Full time
The Role: Oversee the progress of clinical and application research/trials. To ensure all research is conducted, recorded, and reported in accordance with Protocols, SOPs, ICH-GCP and applicable regulatory requirements. Provide a global evaluation of all investigations commissioned and executed. The successful post holder will provide assistance in preparing study documentation for trials, IRB/IEC submissions and documentation for regulatory dossiers.
Solely responsible for ensuring collection of the required essential documents for study start-up and throughout the conduct of a trial. You will conduct on-site training and motivate the investigators. As part of document review, you will ensure accurate data is recorded across multiple investigations and verify patient data. You will ensure adherence to protocol, GCP and internal SOPs. You will maintain all files pertaining to the clinical trials, track study progress and ensure timely quality updates are provided.
Your responsibilities will include routine site visits and assessments. Your role will be to ensure all projects run optimally, and work is completed correctly and within designated timelines. You will bridge the gap between the Principal Investigator and research personnel, providing vital advice and making informed decisions. You will ensure Routine Close-out activities are completed and audit all activities undertaken at each investigative site.
Essential Requirements:
Solid degree in scientific subject
Experience in a clinical research setting; proven clinical trial experience.
Experience in Phase I-IV trials; Phase II - III is preferred.
Working knowledge of EU Clinical Trials Directive, Medical Device Directive, UK Clinical Trials Regulations, Principles of ICH-GCP, GDPR and Research Governance Framework Legislation with proven ability to apply these to the coordination of clinical trials.
Understanding of current EU Medical Device Regulation
Working knowledge of BS EN ISO 14155 is preferred.
Experience working effectively in a team/matrix environment.
Proven ability to manage multiple priorities and communicate effectively.
Key Objectives/KPIs
Motivate research team.
QA/QC investigators daily activities; ensuring compliance with CIP and regulatory compliance.
Ensure research staff achieve targets and deliverables in a timely manner.
Conduct detailed audits and trend analysis on key elements of trial execution; bridge the gap.
Procure, store, and disseminate study supplies (dispensing and accountability), including investigational devices.
Induct, train and mentor new department personnel, including competency testing.
Identify and devise new training materials as deemed appropriate.
Identify and devise new departmental SOPs/WI and template documentation, as deemed appropriate
If you have the required skills and experience required for this role then please submit your CV for immediate response.
CPSwansea
The Recruitment Co. is an equal opportunities employer and we're committed to diversity and inclusion in the workplace.