Clinical Trials Senior Research Co-ordinator

Job overview

As a research governance officer, you will specifically be responsible for the co-ordination and day to day management of a portfolio of studies within the research and innovation directorate with particular oversight of any pharmaceutical and medical device studies.

Main duties of the job

The post holder will support on standards in information governance (IG-R). They will also support other ongoing work streams within the IG Team as required. The post holder will work closely with both health informatics, research informatics team and the delivery team to ensure research activity is understood in terms of security and compliance with the data protection act within the ROH and subcontracted external bodies.

The post holder will assist in this vision by ensuring that all use of Trust data, both personal and non-personal data, meets the highest ethical standards and legal frameworks. The post holder will be the key link for the study team and support on relevant privacy impact assessments and providing high quality advisory service to all trust staff including divisional managers, corporate managers, and clinical staff and most importantly ensuring that the needs of data subjects are always met.

The role is required to work on their own initiative on a regular basis and manage their own workload; this will require excellent planning and organisational skills. The post holder must be able to work communicate information to a wide range of staff groups, i.e. Consultants, external stakeholders. Using their own judgment the post holder will be able to prioritize their workload effectively.

Working for our organisation

The Royal Orthopaedic Hospital NHS Foundation Trust is one of the largest specialist orthopaedic units in Europe. We offer planned orthopaedic surgery to people locally, nationally and internationally.

Our Trust is a very special hospital; big enough to deliver world class services and small enough to offer exceptional patient and staff experience. We offer a working experience unique in the West Midlands and we're always on the lookout for passionate people to join our award-winning team.

The ROH is an equal opportunities employer. We employ people of difference and are committed to growing an inclusive culture, where difference is celebrated, and people feel able to bring their whole and authentic self to work.

We are a Disability Confident Leader and offer a range of inclusive, family friendly and flexible working arrangements and policies, to support our people in the workplace. Flexible working requests will be considered.

The Trust is committed to the Disability Confident Interview Scheme and will offer an interview to disabled applicants who meet the minimum criteria for a vacancy and consider them on their abilities.

If you have a disability and need any support with your application or require any reasonable adjustments to be implemented please do get in touch with the Recruiting Manager for this position so that the team can support you.

• To act as lead for the allocated research study team for the set up and approval of any pharmaceutical or medical device clinical trials
• Establish and maintain effective working relationships across the Trust and with external companies, able to communicate with staff/people at all levels.
• Ensure relevant internal parties as well as funders are advised of new studies and their progress through to active status.
• Hardworking and understands the value of teamwork.
• Good attention to detail.
• Excellent verbal, telephone, and written communication skills
• Works independently, recognising own strengths but can seek advice when necessary
• Provide guidance and support for principal investigators, sharing knowledge of best practice and current legislation/guidance.
• A large degree of working time is spent at a desk using computer for prolonged periods. Other activities include meetings and walking to other areas of the Trust. Some of the time the post holder will go into clinical areas to visit staff. The post holder may sometimes have to meet with staff out of normal office hours.
• Collate study documentation in relation to regulatory requirements including quality checking information sheets, samples request forms etc.
• Maintain a strong and current working knowledge of developments regarding clinical research management regulation and governance and NHS structures and services.
• Check data for errors, liaise with the clinical team for missing data and ensure full documentation of any queries raised.
• Ensure costings for all new studies are undertaken, liaising across departments withing ROH to accurately complete the NIHR costing template.
• To be a member of the west Midlands CRN.
• To be GCP trained and keep up to date in clinical research.
• To support with carrying out risk assessments for research studies and assist with implementing mitigating actions or escalating as required.
• Identify, report and support resolutions of problematic studies and where deviations from agreed timelines are likely.
• Oversee monitoring of IG incidents, proposing corrective and preventative actions and co-ordinate and assist in culminating an incident investigation report.
• To proactively ensure the provision of a comprehensive, high quality and efficient administrative service, including identifying improvements to team and/or department working practices.
• Liaise with finance and research delivery teams to ensure the budgets for inclusion in contracts are appropriate and cover costs of work carried out.
• Use of research IT systems including the NIHR EDGE online database, IRAS (Integrated Research Application System) and CPMS (Central Portfolio Management System), Portfolio Maps (Research study scoping database), CROSS, REDCap and all Microsoft Office packages.

This job description may be reviewed from time to time considering developments and may be amended in consultation with the post holder.

Concentration will be required, and the work pattern may be unpredictable and subject to interruptions when updating plans, research reports and meeting short deadlines.

The role will act as the main point of contact for support and guidance in relation to the studies portfolio from participating sponsors, funders, pharmaceutical partners, regulatory authorities and the trial oversees committees.

Ensuring that appropriate documentation is available for conducting clinical trials alongside the clinical trials protocol and determine which approvals are needed for studies and submissions to HRA, REC, MHRA and other regulatory bodies.

The post holder will ensure that research coordinators are compliant with ICH GCP guidelines.

Person specification

Qualifications

• Degree or equivalent knowledge, training or experience through any combination of alternative study, employment, or voluntary work. OR A levels plus evidence of continuing professional development to degree level.
• GCP training

• Appropriate professional qualification or knowledge of legal procedures and contracts gained through experience

Experience

• Experience of report writing and managing/ analysing complex data
• Plan and organise a broad range of complex activities, adjust governance plans, strategies or programmes
• Significant Operational management experience working within a NHS environment working with clinicians and other health care professionals at all levels of the organisation.
• Articulate/experience of communication with varying levels within an organisation.

• HR – day to day supervision/management of staff and delivers training on a range of subjects.
• Information Governance or Research Governance experience.
• Contract experience
• Demonstrable experience in the research department

Knowledge

• Understanding of Good Clinical Practice (GCP) and the EU clinical trials directive
• Knowledge of Common law of Confidentiality, Data Protection Act 2018 and GDPR.
• Able to understand and work within Trusts policies of data protection, equal opportunities, health and safety and meet differing needs of patients.
• Essential IT skills in word, excel, PowerPoint, access, MS teams and email systems.

• In-depth understanding of clinical research and trial management methodology, including applicable regulatory requirements.
• Writing Data Protection Impact Assessments (DPIAs)

Skills

• Excellent health and attendance record.
• Able to Work under pressure
• Self-motivated and enthusiastic
• Ability to work as part of a team and autonomously.
• Commitment to working flexibly to contribute to developing patient care
• Team player
• Ability to deal with distressing situations
• Plan and organise routine activities
• Ability to identify changing priorities
• Reliable