Clinical Research Quality Control Officer - Re:Cognition...

at  ReCognition Health

ABOUT THE COMPANY:

Join a rapidly growing team that is a global leader in clinical trials! Re:Cognition Health, a leading provider of clinical trial research specializing in cognitive impairment, is looking for an ambitious, organized, and highly motivated Clinical Research Quality Control Officer for its clinical trials team. Re:Cognition Health’s clinics are major centers for international trials of disease-modifying drugs for Alzheimer’s disease and other neurological conditions.

REQUIREMENTS:

• Bachelor’s Degree in a science, technical, health-related field
• Minimum 10 year of previous or current experience in a pharmaceutical, biotech, CRO setting, or as a Clinical Trials Associate
• IT Proficiency (Microsoft Office package)
• GCP trained
• Excellent verbal and written communication skills

THE ROLE:

The Clinical Research Quality Control Officer’s primary responsibility will be providing critical support and assistance in the administrative management of the clinical trial studies for all Re:Cognition Health sites. The post holder is will be based in London for 3 days per week, and expected to travel across the UK to other sites for 2 days per week. The post holder will be working with a cutting-edge clinical research team, closely with the Study Coordinator, Principal Investigator and Senior Management teams to maintain and organize study files for each trial.
The ideal individual is a dedicated, hardworking individual with an interest in cognitive disease and clinical research.

RESPONSIBILITIES:

• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Review core trial documents to ensure compliance with SOPs and regulatory requirements and to perform consistency and quality control checks.
• Assist with preparation of trial specific source documentation, to ensure protocol and ICH GCP compliance, and ensuring ALCOA+ principles are ensured.
• Manage/oversee quality events updates and/or maintain SOPs and provides support in relation to the audit lifecycle.
• Advise sited on adequate records keeping and ensure all relevant information is accurately documented in the study participant’s files.
• Assist with collating, submitting, and tracking source data and data queries to Data Management within the set timeframes. Maintain clinical trial databases.
• Meet all annual job-related training and compliance requirements for a Clinical Research Quality Control Officer.
• Raise and manage all quality issues.
• Provide expert advice and guidance to the teams responsible for creating and managing Investigator Site Files (ISFs), including undertaking regular audits of ISFs to ensure compliance with regulatory requirements.
• Establish an internal risk-based audit program of both systems and trials, working with other teams as required (e.g. Information Governance team and senior trial managers). Plan and perform internal audits of processes and provide formal written feedback to include guidance on corrective and preventive actions (CAPA) to address any non-compliance with procedures and/or clinical trial regulations.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA) and Effectiveness Check (EC) plans and track till closures for quality events arising from Quality Issues, Audits, Inspections or during similar QA activities.
• Facilitate preparation, delivery and close out of regulatory inspections and sponsor audits, guided by the Clinical Trials Director.
• Lead/collaborate/support in QA initiatives/projects for quality, process improvements.
• Ensure that Policies, Standard Operating Procedures (SOPs) and Internal Operating Procedures (IOPs) are reviewed periodically and advise on required updates to ensure compliance with ethical, regulatory and other relevant frameworks, making recommendations for improvement where appropriate.