Senior Research Data Clerk

7 months ago


Nottingham, United Kingdom Nottingham University Hospitals NHS Trusts Full time

Communication To have high levels of verbal and written communication with internal and external stakeholders in order to respond to complex queries and meet contractual obligations. To appropriately signpost trial patients contacting the department to relevant healthcare professionals. Communicate effectively with the members of the clinical research team, patients and relatives, outside agencies and the wider Multi-Professional Team as appropriate. Act professionally to ensure that confidentiality of all information pertaining to patients and trials is maintained at all times.

Clinical Trials Administration To be a point of contact with Sponsors for data related activity including management of onsite and virtual monitoring visits and review of site file maintenance. Have a responsibility for a wide range of cross specialty trials which vary to each specific protocol. The post holder will receive and check documentation, access hospital patient information systems, confirm source data and resolve queries in a timely manner. To liaise with the trial caseholder to ensure data integrity prior to submission and data lock.

To liaise with and manage organising visits from external trial monitors, including obtaining patient records, scan results etc. in liaison with the research team. To respond to data queries in a timely manner and escalate to trial case holders and principal investigators when necessary. To review trial data information requirements prior to trial start up and attend other appropriate trial related meetings.

Ensure that site files are accurately compiled and complete prior to greenlight initiation. To assist research team members in the appropriate management and coordination of identified clinical trials. Ensure the implementation and maintenance of clinical research, including maintenance of delegation logs and spreadsheets as appropriate. To have a good knowledge of all clinical trials taking place in the research team, both those to which patients are currently being recruited (open) and those, which are no longer recruiting patients (closed and in follow up).

Adhere to codes of practice covering confidentiality, data protection and ICH-GCP. Data Collection To review patient data from medical and nursing records and perform accurate completion of complex electronic case reports forms working to ICH GCP and research governance guidelines. To be responsible for additional clinical trial data from other departments and external organisations. To liaise with the research team, medical staff and the wider MDT to obtain timely source data.

according to trial protocols. To use electronic databases to search for, access and retrieve published scientific literature and publicly accessible datasets. General Office Administration To undertake general office work and any other appropriate duties assigned by the research team leader To undertake any other duties deemed appropriate for the role. Participate and organise departmental research meetings as appropriate.

Take an active role in self-development, objectively reviewing own performance, identifying own needs and taking steps to meet those needs. Keep abreast of potential developments. Have high levels of competence in the use of electronic hospital systems. Manage the filing of data related activity - ensuring documents are correctly filed in patient records and in investigator site files



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