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Study Monitor - Swansea, United Kingdom - Cyden Ltd
Description
Overall job purpose:
1.Oversee the progress of clinical and application research/trials.
2.Ensure all research is conducted, recorded, and reported in accordance with Protocols, SOPs, ICH-GCP and applicable regulatory requirements.
3.Provide a global evaluation of all investigations commissioned and executed.
Background:
We are looking for a Study Monitor to join our expansive Clinical and Application Research Team. The successful post holder will provide assistance in preparing study documentation for trials, IRB/IEC submissions and documentation for regulatory dossiers. You will be 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.
The successful candidate will have a strong interest in clinical trial and application research, and experience of working in a similar role. You will have excellent organisational, planning, and interpersonal skills. You will thrive from working under pressure and demonstrate initiative and problem-solving skills. You will have knowledge of clinical trials regulations, ICH-GCP and excellent literacy, numeracy, and IT skills.
We are looking for that exceptional person who brings progressive ideas, a positive attitude, and a professional demeanor.
Key Objectives/KPI's
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.
Assume full study monitor responsibility.
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
Skills, know-how & experience:
Essential Attributes
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.
Other Attributes
Excellent Organisational Skills.
Eye for Detail. You operate with a strong sense of due diligence.
Excellent Communication Skills. An inspiring communicator. You communicate clearly and concisely. You are effective in conflict resolution. You have the ability to handle different views to find a sensible way forward for a project. You communicate with a collaborative approach.
Diligent. Attentive and assiduous. Thoroughly investigate and verify issues.
