Clinical Research Compliance Associate

Job Title: Clinical Research Compliance Associate

Location: London Bridge, SE1

Term: Full-Time, Permanent

Salary: Competitive + Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more)

Richmond Pharmacology are an early phase Clinical Research Organisation (CRO), where we are conducting pioneering early phase healthy participants and patient participant trials. Our experienced and world-renowned team, our central London location and our global reach contribute to making Richmond Pharmacology an exciting and dynamic place to work.

Purpose of the job

The Clinical Research Compliance Associate role primarily oversees clinical procedures and ensures accurate, complete data collection adhering to ICH GCP Guidelines, study protocols (CSPs), SOMs, SOPs, and other relevant regulations. Clinical Research Compliance Associates focuses on promoting, implementing and embedding the culture of 'Do It Right the First Time' for the purpose of ensuring clinical research trials and data quality integrity is upheld at the highest standard in accordance with ICH GCP and other regulatory requirements standards. The role fits in the newly setup functional department - Clinical Research Compliance Department. The new CRCA role encompasses the transformational aspects of being proactive in adherence of clinical compliance standards in all relevant aspects to clinical study.

The CRCA roles will include the management of all aspects of external monitoring visits, understand the nature of their queries and where applicable verify the validity of such queries in accordance with the ICH GCP standard requirements.

Main duties and responsibilities

External Monitors and Clinical Research Auditors Management and Reporting

• Support CRCMs in the delivery of induction and refresher training to EMs/CRAs to ensure Richmond processes and systems are well understood

• Coordinate and supporting CRCMs to liaise and coordinate with internal stakeholders with all aspects to EMs/CRAs site visits, ensuring the necessary documentation and information availability; and any query related activities are addressed in a timely manner.

Training and Education

• Support and coordinate to ensure clinical research team members are up to date to the latest compliance matters and standards

• Be a point of contact for coordination and liaison for CRC team for training needs analysis and organisation of relevant training

Quality Assurance and Quality Control:

• Maintain a comprehensive planned quality control activities for clinical research activities.

• Perform internal data quality control to ensure:

• the quality of clinical procedures performed, and any study data collected to ensure it is complete, correct and conforms to all requirements, ICH GCP Guidelines

• accuracy of data collection for all study as per Richmond guidelines agreed by PIs and Sponsor where applicable.

• Where applicable and necessary, support in resolution of VDB/EDC queries
• Support CRC team in adoption of Risk Base Quality Management (RBQM) approach through the establishment of robust statistical process control using six sigma methodologies

Collaboration and Communication

• Support CRCMs as a liaison between the research team and external monitors, facilitating communication and addressing inquiries or concerns.

Risk Management and Mitigation

• Manage and maintain risks associated dataset with clinical research activities primarily in compliance perspective

Continuous Improvement and Monitoring:

• Collate and evaluate the effectiveness of the compliance program supporting CRCT performance

• Collectively work with CRCMs to Implement process improvements and best practices

Documentation and Reporting:

• Maintain documentation of compliance activities, audits, and corrective actions.

• Support preparation of compliance reports to the study team, and other stakeholders

• Support in maintaining the tracking of protocol deviations list and undertake trend analysis

• Responsible for maintaining the compliance KPIs dataset by working closely with insight analyst for CRC team as well as ensuring the distribution of compliance analytics to CRCMs

Skills and Experience:

• BSc or above in Life Sciences, Nursing or Pharmacy (not necessarily registered in the UK)
• Previous data monitoring experience in CRO or pharma for clinical trials is desired

Application:

If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.