Trial Manager

We are looking to recruit a Trial Co-Ordinator to join the Birmingham Clinical Trials Unit to support the clinical research being undertaken by the unit. Trial Coordinators are responsible for the day-to-day management of trials within Birmingham Clinical Trials Unit.

A key responsibility of the postholder is to ensure patient recruitment meets targets. The postholder must be able to communicate the underlying medical and scientific rationale of the studies to a wide professional and public audience. This will require close liaison with clinical research staff.

The Trial Coordinator will also be responsible for the production of promotional material, answering queries and resolving any technical or administrative barriers to participation.

Key responsibilities

• Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards of the Clinical Trials Unit and that appropriate records and audit trails are maintained.
• Ensure that the trial complies with current regulatory reporting requirements (e.g. of adverse events) to the relevant bodies e.g. competent authorities, ethics committees, investigators etc.
• Set up clinical sites, prepare ethics committee and regulatory submissions and ensure that the staff at participating sites understand and are able to comply with the protocol.
• Monitor progress of each site and take appropriate action to ensure good recruitment; compliance with the protocol, and the quality and timeliness of the data collection.
• Use initiative to tackle any practical difficulties reported by sites i.e. those which affect recruitment, protocol or Good Clinical Practice compliance or patient safety.
• Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required.
• The Trial Manager may contribute to the design, analysis, publication and presentation of the research.
• This may involve writing research grant applications; contributing to the design, development and feasibility/testing of protocols; case report forms; coding lists, and databases. Also, writing abstracts; designing posters. and contributing to journal articles.
• Responsible for the collection, processing and secure storage of the study documentation.
• Apply an in-depth understanding of the clinical research to ensure that the methods used to implement and conduct the protocol are consistent with answering the key research questions reliably. This will involve developing work plans to translate the major methodological requirements into practice. Plans must consider the wider implications i.e. to colleagues; policies of the Clinical Trial Unit; Good Clinical Practice; quality management; feasibility; costs, and deadlines.
• Organise and administer the external collaborative group.
• Identify, recruit and support participating sites.
• Provide regular feedback on the progress of the trial and encourage sites to meet recruitment targets.
• Plan and organise mailshots, newsletters and collaborator or investigator meetings.
• Maintain the trial website.
• Responsible for ensuring that the collection of data during the course of the trial is conducted so as to provide a complete, accurate and up to date trial data set(s) for analysis according to agreed deadlines.
• Train and supervise other staff (internal and external) involved in data management in the rules and procedures to be used, explaining the reasons/ principles behind them.
• Enter data onto the computer databases and perform regular systematic checks of information held on the trial database(s).
• Decide what steps need to be taken to correct any missing, contradictory or incorrect data and ensure that these problems are followed through to a satisfactory conclusion within a reasonable timescale.
• Monitor for systematic or serious errors and inconsistencies, breaking problems down to identify their cause in order to take action to improve working systems and prevent recurrence.
• Develop and document guidance notes and procedures for the conduct of the trial and ensure other members of staff are fully trained to understand and follow them. Create trial management tools including forms and databases.
• Prepare trial reports as required for example progress reports required by the Clinical Trail Unit management and the various trial steering and data monitoring committees, funding bodies or sponsors.
• Maintain the Clinical Trial Unit's Central Administrative Database.
• Coordinate and support the activities of the trial management group, steering and data monitoring committees. Represent the Clinical Trial Unit's interests and policies effectively at this level and report back to management. Key member of the trial management group contributing to the content, type and frequency of the case report forms to collect the information required to answer the research questions reliably and efficiently.
• Designing case report forms etc. to be as attractive and easy to use thus promoting error free data return.
• In discussion with clinical investigators decide the rules and procedures that will be used for coding, interpretation, entry and checking of the data. Record and code incoming forms and/or abstract from source records for data entry, checking for inconsistencies, violations and unusual or adverse events. Where necessary, agree new or changed rules, codes and procedures for the entry of non-routine or ad-hoc data with the trial management group.
• Maintain and circulate coding lists and inform other trial management staff of changes.
• Work with the trial statistician, performing preliminary and routine data analysis.
• Contribute to the work of the trial management team, supporting the Senior Trial Manager and/or Trial Team Manager, lead statistician and principal clinical investigators in the development and conduct of the team's entire portfolio of research.
• Represent team on Clinical Trial Unit committees e.g. web committee, publicity committee etc. Contribute to the Clinical Trial Unit's Quality Management System.
• Keep up to date with current research literature and developments in both the professional field and the clinical site speciality. Maintain relevant bibliographies by regular literature searches and critical review. Developing and publishing innovative approaches to improving trial methodology is encouraged.
• Present and give talks on the research (i.e. about the clinical trial and trial methodology) both internally and at major scientific / collaborators meetings. Managers may have some lecturing and teaching duties within the School and on the various clinical trial professional development courses. Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the Research Governance Framework for Health and Social Care, Coldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University's Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.

Person Specification

• An in-depth understanding of clinical research and trial management methodology and proven ability to apply these to the development, testing and implementation of trial management procedures.
• Excellent office management and clerical skills that include word processing & document layout.
• Experience and understanding of techniques for the management of medical research information e.g. data coding, entry validation and reporting.
• Ability to develop automated office procedures and to manage complex relational computer databases.
• Experience in the design, maintenance and interrogation of complex relational databases (MS Access or SQL Server preferred). Experience of using statistics packages such as SPSS and SAS e.g. to perform appropriate statistical tests and procedures for routine analysis and management of the trial data.
• Proven administrative and project management skills.
• Able to work on own initiative and problem solve.
• Effective communication, negotiation, presentation and inter-personal skills.
• Ability to demonstrate critical and intelligent attention to detail and high standards of accuracy.
• Ability to meet the travel needs of the post which includes travel in the Birmingham area and further afield on occasions.

Contact

Informal queries can be made to Caroline Rick - C.E.Rick@bham.ac.uk