Trial Coordinator - Health and Medical
- Full Time
The Trial Coordinator will be a member of one or more trial working groups, responsible for the management and organisation of the trial(s) office for the conduct of large, clinical trial protocols and administration of the clinical collaborative groups. He/she is expected to be capable of the continued development, critical appraisal and documentation of appropriate procedures for managing trial protocols effectively. This requires specialist expertise and experience and a good understanding of how the theories and concepts that underlie the design, conduct and analysis of clinical trials are applied in practice. Trial Coordinators are expected to make an active contribution to setting, maintaining and communicating CRCTU policy, quality standards and trial management frameworks.
Duties and responsibilities
- Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and CRCTU quality standards 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.
- 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. which affect recruitment, protocol or Good Clinical Practice compliance or patient safety.
- Conduct initiation, problem solving, monitoring, quality assurance/audit visits as required.
- Apply 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, CRCTU policy, Good Clinical Practice, quality management, feasibility, costs and deadlines.
- 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.
- Keep up to date with current research literature and developments in both the professional field and the disease site speciality.
- Maintain relevant bibliographies by regular literature searches and critical review.
- Developing and publishing innovative approaches to improving trial methodology is encouraged.
- Higher degree in a relevant biomedical or associated subject, or graduate with strong experience in clinical research.
- 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.
- Office management and clerical skills that include excellent 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.
- Can take own decisions to organise the work of a professional team under management guidance.
- Effective communication, negotiation, presentation and inter-personal skills.
- Must demonstrate a 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 occasion.
Promising candidates who lack the experience to coordinate a trial independently may be accepted for training.
Informal queries can be made to Anna Lawson - firstname.lastname@example.org.