Detailed job description and main responsibilities

To work according to Good Clinical Practice  (GCP) and research governance standards for clinical research studies

To provide an effective quality data management service to delivery organisations within the Research Delivery Network (RDN). To act as a resource and role model for junior staff and the wider multidisciplinary team.

To identify and work within Standard Operating procedures (SOPs) in accordance with individual study site requirements.

To support the set up and conduct of randomised controlled trials and other NIHR Portfolio studies

To create databases for identification, tracking, recording and reporting of the patient pathway, relevant to achieving on time and to target objectives for patient recruitment

To ensure that the clinical study protocols you are working on are adhered to. Assist research staff and clinicians to ensure protocols are accurately followed.

In collaboration with Study Managers ensure that every study which involves patients transferring between Organisations has a defined pathway. This will require liaison with staff in multiple organisations.

To transcribe/export data from medical records (paper or electronic) to case report forms (CRFs) (paper or electronic) as required by the protocol and return these to the study coordinating centre in a timely manner, liaising with Research Nurses, Clinicians and other research staff as necessary to ensure accuracy of completion

To act appropriately to report and record serious adverse events, this includes communication with the Principal Investigator and site team, Sponsor teams, relevant regulatory bodies and local personnel.

To take responsibility for liaising with multiple organisations (e.g. Clinical Trials Units) regarding data queries and for checking and resolving data queries, establishing and maintaining a robust system of documenting these queries

Use the Local Portfolio Management System and other trial specific tools to identify when new data is required; take responsibility for quality control, checking validity and completeness of all recorded data and reports presented to the required timetable and to track patient activities across multiple Partner Organisations

Work with other members of the study team in the provision of a comprehensive study service

To complete eligibility forms for study patients and to ensure that all relevant data has been recorded

To randomise /register patients to studies according to protocol requirements, as required

To assist in ensuring that protocol required tests/procedures are done according to the schedule in the specific study protocol

Liaise with Study Coordinators for specific study protocols and procedures

To ensure that clinical study recruitment records are accurately maintained.

To ensure safe filing and storage of study documentation and samples in accordance with Good Clinical Practice and Research Governance

Maintain sufficient stocks of documentation and equipment required for studies (e.g. CRFs, Questionnaires, Blood Sample Kits)

To arrange couriering of samples and ensure the contained samples are delivered safely and securely to the necessary destination.

To organise and prepare for visits by trial monitors, inspectors and internal auditors

To attend meetings relevant to the nature of the job

For full Duties and Responsibilities please see attached Job Description on the Trust website