Alder Hey Children's NHS Foundation Trust
The main purpose of the role is to support the clinical research team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies.
The post-holder will be responsible for supporting the set up and delivery of clinical trials within the Clinical Research Division from feasibility to archiving including (but not limited to):
* Assist with the efficient and timely set up of clinical trials
* Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines.
* Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines.
* Assist with preparation for audit and inspections within assigned teams.
* General trial-related communication in accordance with the Data Protection Act.
* Assist with maintenance of clinical trial documentation.
* Completion of Case Report Forms (CRFs) ensuring all patient data is collected accurately.
* Responsible for reporting of any Serious Adverse Events (SAE) within required timeframe
* Assist with the tracking and raising of invoices.
* Direct contact with patients and families to support study visits.
Main duties of the job
* Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations, joint research office and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
* Set up and initiation of allocated trials.
* Maintain investigator site files and essential documentation in accordance with ICH, GCP and Trust SOPs to ensure they are always kept inspection ready.
* Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
* Ensure collection of clinical case notes for all patients for monitoring and audit purposes, arranging and securing access to electronic records for external monitoring visits.
* Study specific training for use of electronic databases/portals.
* Completion of CRFs, data entry and data query resolution in a timely manner.
* Assist with preparation for audit and inspections.
* Attend and contribute to team and departmental meetings.
* Assist with trial document archiving by following the Trust's archiving guidelines.
* Ensure that office/trial related supplies are adequate and assist with the ordering process. Undertake general administrative tasks as delegated by the Research Governance Manager and Senior RFs.
Person Specification
Qualifications
* Education to a minimum of GCSE standard or equivalent
* ECDL qualification
* Relevant training courses in clinical research
Experience
* Previous research/data collection or clinical audit experience
* Experience of working within a health care system.
* Able to assess and interpret clinical/non-clinical information.
Knowledge
* Knowledge of the clinical trials process.
* Familiar with GCP guidelines/EU directives
* Knowledge of issues relevant to paediatric research.
* Knowledge of patient information systems.
Skills
* Good organisational skills
* Good verbal and written communication skills.
* Ability to work autonomously and as part of a team
* Good interpersonal skills
* Experience of working with MS Office applications
* Ability to troubleshoot effectively.
Other
* Ability to work to tight and/or unexpected deadlines.
* Flexible.
* Conscientious and hardworking.
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
Alder Hey Children's NHS Foundation Trust
£26,530 to £29,114 a year Per annum pro rata
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