Detailed job description and main responsibilities

Role Duties & Responsibilities

The specific responsibilities will depend on the requirements of each team, but may include:

Trial Administration

·         Assist with trial setup, initiation, and amendment processing in line with ICH-GCP and Trust SOPs.

·         Maintain investigator site files and essential documentation to ensure inspection readiness.

·         Complete case report forms and liaise with monitors to resolve data queries promptly.

·         Track trial-related payments and request invoices as per contractual agreements.

·         Assist with financial reporting and department-level data reporting, including collection of trial data where delegated and appropriate.

·         Arrange shipment of samples and reproduction of scans according to protocol requirements.

·         Screen clinic lists and wards to identify potential participants for trials, ensuring adherence to inclusion/exclusion criteria.

·         Approach potential participants in a professional and ethical manner to provide study information and support informed consent processes under delegation from the PI.

·         Assist with delegated follow-up visits and study-related procedures where appropriate and safe to do so.

·         Support the clinical team in patient-facing areas where safe and appropriate, under delegation from the PI and in line with protocol requirements.

·         Potentially collect data where appropriate per trial and as delegated.

·         Study follow-up visits as delegated by PI and appropriate per trial.

Data & Compliance

·         Ensure accurate and timely data entry into electronic data capture (EDC) systems and trackers.

·         Support safety reporting processes under the guidance of Principal Investigators.

·         Prepare for audits and inspections, ensuring compliance with UK Policy Framework, GDPR, MHRA guidance, and ICH E6(R3) GCP standards.

·         Report protocol deviations and escalate issues as per SOPs.

·         Coordinate patient feedback collection and reporting for quality improvement.

Communication & Coordination

·         Act as a point of contact for sponsors, CROs, and internal teams regarding trial conduct.

·         Organise trial-related meetings, prepare agendas, and produce minutes.

·         Liaise with NHS departments for case notes, mortality data, and archival materials.

·         Support departmental communications, including social media updates, ensuring compliance with Trust policy.

General Administration

·         Maintain adequate office and trial supplies, assisting with procurement.

·         Manage team diaries and coordinate scheduling for research activities.

·         Undertake administrative tasks delegated by the R&D management team.

Governance

·         Adhere to Trust policies on confidentiality, infection control, and equality.

·         Ensure compliance with all relevant legislation and ethical standards.

Managerial / Leadership

·         Work independently, prioritising workload to meet deadlines.

·         Provide feedback on processes and suggest improvements.

·         Support induction and mentoring of new staff under guidance of R&D management. 

Education /Learning

·         Maintain professional development and participate in training aligned with NHS Knowledge and Skills Framework.

·         Attend relevant study days, seminars, and investigator meetings.

VALUES

All staff at MCHFT have a responsibility to adhere to the following Trust values. 

•    Maintain active registration status
•    Always act in accordance with professional Codes of Conduct and guiding documents 
•    Where applicable, always act in accordance with the Code of Conduct for NHS Managers
•    Maintain up to date skills and knowledge 
•    Maintain an awareness of patient led service issues 
•    Maintain a professional/personal portfolio
•    Adhere to all Trust policy, procedures, and guidelines.
•    Adhere to Trust standards of behaviour and expected performance
•    Comply with Infection Prevention and Control (IP&C) policies and procedures as appropriate to their role and responsibilities in their individual work setting. Staff are required to be personally accountable for their actions and be responsible for their own compliance in relation to IP&C polices, protocols or advice.
•    Ensure they work in accordance with local procedures and report any issues which they consider to be a risk to the health and safety of themselves and/or others. 
•    Act in accordance with the Trusts values 
•    Where applicable to participate in and provide data on the efficacy of treatment and specialties