Clinical Trials Senior Research Co-ordinator

Clinical Trials Senior Research Co-ordinator The Royal Orthopaedic Hospital NHS Foundation Trust

As a research governance officer, you will be responsible for the coordination and daily management of a portfolio of studies within the research and innovation directorate, with particular oversight of pharmaceutical and medical device studies.

Main duties of the job

The post holder will support standards in information governance (IG-R) and other work streams within the IG Team. They will work closely with health informatics, research informatics, and the delivery team to ensure research activities comply with data protection laws within the ROH and external bodies.

You will ensure all use of Trust data, both personal and non-personal, meets ethical and legal standards. You will be the key link for the study team, supporting privacy impact assessments and providing high-quality advice to staff, including ensuring the needs of data subjects are met.

The role requires working independently, managing your workload with excellent planning and organizational skills. You must communicate effectively with a wide range of staff, including consultants and external stakeholders, and prioritize tasks effectively.

About us

The Royal Orthopaedic Hospital NHS Foundation Trust is one of Europe's largest specialist orthopaedic units, offering planned orthopaedic surgery nationally and internationally.

We are committed to providing exceptional patient and staff experiences, fostering an inclusive culture, and supporting flexible working arrangements. We are a Disability Confident Leader and support applicants with disabilities through reasonable adjustments.

Job responsibilities

Lead research study teams for the setup and approval of pharmaceutical or medical device trials.

Establish effective relationships within the Trust and with external partners, and communicate study progress.

Provide guidance to principal investigators, ensure regulatory documentation is complete, and maintain knowledge of research regulations and governance.

Manage data quality, oversee study costings, and ensure compliance with GCP guidelines.

Utilize research IT systems such as NIHR EDGE, IRAS, CPMS, REDCap, and Microsoft Office tools.

Support risk assessments, incident management, and continuous improvement of administrative processes.

Coordinate with finance and research teams to ensure accurate study budgets and documentation.

Ensure study documentation aligns with regulatory requirements and support study approvals from bodies like HRA, REC, and MHRA.

Person Specification Qualifications

• Degree, equivalent experience, or A levels with ongoing professional development.
• GCP training.
• Relevant professional qualification or legal knowledge.

Experience

• Report writing, data management, and analysis.
• Operational management within the NHS.
• Experience with research governance, data protection, and working with multidisciplinary teams.

Knowledge

• Understanding of GCP, EU clinical trials directive, Data Protection Act 2018, and GDPR.
• Knowledge of NHS policies and clinical research methodologies.

Skills

• Excellent communication and organizational skills.
• Ability to work under pressure and independently.
• Teamwork, reliability, and flexibility.

Other

This position requires a Disclosure and Barring Service check.

Employer details

The Royal Orthopaedic Hospital NHS Foundation Trust

Address

The Royal Orthopaedic Hospital NHS Foundation Trust

Research Governance and Contracts Manager

Salary: £37,338 to £44,962 per annum (pro rata)

Contract and hours

Permanent, Full-time

Reference number

380

Location

The Royal Orthopaedic Hospital NHS Foundation Trust