Checklist - key roles in the trial team

This list of key roles within the trial team and the personal/general characteristics and particular strengths required to take on the role has been provided by Fernando Althabe and team, Argentina

Trial manager

Personal characteristics: well respected, committed, available, multi-talented, hard working, well organised, capable of forward planning excellent communicator. he or she should never underestimate the importance of common sense and obsessional attention to detail in trial management.

Strengths should include: Ability to work within a team and organise it, management skills, strategic planning, ability to prioritise, motivator/listening skills, focused but flexible approach, perseverance, knowledge/experience of all relevant guidance/regulations.

Trial coordinator or clinical monitor

General Characteristics: availability to travel and to remain away form home for extended periods, excellent communication skills, be able to maintain emotional as well as intellectual empathy with physicians and their assistants, good speaking voice as they will be responsible for the training in data entry of the study physicians and their staff, acquire a knowledge of the clinical trial literature for the specialty under investigation.

Data manager

General Characteristics: attention to detail, accuracy, being a team player, pro-active and involved, ability to work with the project manager and understand the requirements of the trial, must possess a general knowledge of both data entry and data management software and be able to prepare flow chart for the development process, knowledge of RCTs and an in-depth knowledge of the specific trial being conducted, ideally he or she will possess a knowledge of the statistical analysis software that will be used.

Data clerk

General characteristics: methodical, accurate, reliable and a team player.

Statistician

General characteristics: experienced in trials, open minded, committed, a team player and preferable PhD level.

Clinical monitor or research assistant

General characteristics: specialists in the area under investigation, a team player, committed and must be available.

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