Click on a number to see the correponding competency definition, or scroll down this page. Suggested abilities of staff who demonstrate that competency are taken from real-life examples of clinical research job descriptions.
1- Oversight
Competency Definition: The individual can plan the practical aspects of starting the study based on the protocol, including conducting early feasibility and risk assessment. They prepare study teams, including setting up and managing oversight committees, and negotiate start dates and milestones with all parties. They conduct site selection activities, and understand the needs of the chosen sites to address before study start, for example recognising the need for specific training or equipment. They run launch meeting and site initiation meetings, and ensure that the sites have the relevant information and documentation, such as the investigator’s brochure (IB) and site specific information (SSI). Individuals managing study initiation should have a good knowledge of the planned study operations so as to be able to execute them appropriately from start, and a thorough understanding of the protocol.
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Abilities
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Related competencies Similar tasks: Developing a protocol; Developing study plans and documents; Developing the QMS and SOPs; Working as per the QMS; Securing and maintaining approvals; Securing and maintaining contracts; Project management; Human resources; Overseeing essential documents; Logistics and facilities management; Engaging with the community Required skills: Strategic leadership; Interpersonal skills (negotiation); Organisational skills |
Competency Definition: The individual is able to perform study close-out activities such as site close-out visits, and reconciliation of study supplies at the end of the study. They write and coordinate relevant notifications (e.g. to institutions, regulatory authorities). They have an understanding of the requirements of the sponsor, regulatory bodies, GCP and any other applicable standards for archive of trial data and documents, and make relevant arrangements. They arrange for database lock at an appropriate time-point. Performing study closure requires good knowledge of the relevant guidelines and good project management and reporting skills.
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Abilities
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Related competencies Similar tasks: Disseminating study findings; Controlling quality of research (monitoring); Securing and maintaining approvals; Project management; Reporting; Overseeing essential documents; Data management Knowledge base: Research regulations; Good Clinical (or other) Practice Required skills: Organisational skills
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Competency Definition: The individual manages the study implementation and oversees the conduct of all activities from initiation to completion of the research project. They keep oversight of the project timeline, financing, human resources, other resources and logistics, in particular at and between groups and sites. They coordinate the relevant processes and teams, using project management tools if required.
Project management demands organisational and time management skills, and the ability to prioritise conflicting needs in order to successfully coordinate the activities of different parties (laboratories, research sites, etc.) involved in a clinical study.
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Abilities
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Related competencies Similar tasks: Developing study plans and documents; Developing the QMS and SOPs; Working as per the QMS; Controlling quality of research; Securing or maintaining contracts; Initiating study; Closing study; Tracking study progress; Liaising or acting as a link; Human resources; Supervising or mentoring; Logistics and facilities management; Finances management Required skills: Strategic leadership; Cognitive skills (problem-solving); Interpersonal skills; Organisational skills |
Competency Definition: The individual understands the project scope, milestones, budgets and timelines and can appropriately track the progress of these against the original planned target. They review status reports from other members of the team in relation to meeting these milestones, and can analyse the progress sufficiently to anticipate problems in advance.
Tracking study progress requires good project oversight and managerial skills, along with good attention to detail and record-keeping, as the individual must constantly keep an eye on others’ activities, on goals and targets and ensure they are met.
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Abilities
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Related competencies Similar tasks: Working as per the QMS; Controlling quality of research; Closing study; Project management Required skills: Cognitive skills; Organisational skills; Record-keeping |
2- Study communications
Competency Definition: Reporting can take the form of oral or written accounts of activities, which may take place at scheduled meetings or upon request from team members or stakeholders. This might be a continuous task (regular updates) or a time-driven one (requested reports).
This task requires language and communication skills (presentation and writing) as well as organisational skills, and aims to ensure that every party is aware of the progress of the study and that issues are escalated to relevant bodies. The individual understands the importance of escalating issues whether informally in the team or formally to authorities, and can do so as required. The individual understands the importance of reporting appropriately to relevant groups, for example keeping authorities and stakeholders informed of progress and issues. They can write and present reports according to the requirements of audience.
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Abilities
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Related competencies Similar tasks: Disseminating study findings; Risk and safety management; Tracking study progress; Liaising or acting as a link; Facilitating or attending meetings Required skills: Language and communication skills (presentation and writing); Organisational skills; Record-keeping |
Competency Definition: The individual maintains regular communications and interactions with study site(s), teams and relevant departments to ensure smooth and successful execution of trial activities. They make sure to constantly update and circulate new information to other parties in the trial, including protocol, SOPs, informed consent forms, etc. to study staff, and data or adverse events reports to review boards and sponsors.
In order to establish and maintain working communication between parties within a trial, point-of-contacts need interpersonal skills, good language and communication skills, as well as sound knowledge of the organisational context they are embedded in.
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Abilities
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Related competencies Similar tasks: Controlling quality of research; Securing or maintaining contracts; Project management; Tracking study progress; Reporting Knowledge base: Governance and organisational context Required skills: Interpersonal skills; Language and communication skills |
Competency Definition: Active participation in meetings encompasses multiple tasks, such as planning and organising, chairing and facilitating, as well as presenting or interacting with others. The individual has the ability to organise, plan, manage and record the outcomes of the meeting appropriately. They take detailed minutes of meetings to subsequently circulate discuss information and reached decisions to others, which necessitates good record-keeping skills. Senior individuals may chair meetings as required. This task requires interpersonal skills to facilitate active and useful discussions so as to achieve maximum efficiency.
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Abilities
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Related competencies Similar tasks: Liaising and acting as a link; Reporting Knowledge base: Governance & organisational context Required skills: Interpersonal skills; Organisational skills; Language and communication skills; Record-keeping |
3- Staff management
Competency Definition: The individual can recruit and select an appropriately qualified team. They hold CVs and training records of study and site staff, and update them as appropriate. They ensure that individuals have received sufficient instruction to carry out their research activities, and can direct them to training when required to bridge gaps in knowledge, or when needed (e.g. coordinating GCP refreshers). They must also ensure that staff will be equipped to perform their job safely and act in a sound and safe manner at the workplace (e.g. availability and consistent use of Personal Protective Equipment, up-to-date vaccinations).
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Abilities
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Related competencies Similar tasks: Initiating study; Project management; Creating or delivering training; Supervising or mentoring; Overseeing essential documents; Logistics and facilities management Knowledge base: Good Clinical (and other) Practice (safety rules); Research regulations Required skills: Strategic leadership; Record-keeping |
Competency Definition: The individual delivers relevant information in a meaningful way to others. They develop appropriate training objectives based on the needs of the group, and develop interesting and useful materials for training. When delivering training (e.g. in lectures or seminars), they are clear, effective and adapt their material and speech appropriately. The individual can also train individuals in a specific task or perform On-the-Job Training when needed.
To deliver effective training, the individual requires excellent language and communication skills, and good interpersonal skills to respond to trainees. They already have, or seek to gain, a full understanding of the subject to be covered (e.g. the study protocol or SOPs).
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Abilities
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Related competencies Similar tasks: Developing study plans and documents; Human resources; Supervising or mentoring Required skills: Interpersonal skills; Language and communication skills
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Competency Definition: The individual has the ability to lead, motivate, mentor, supervise, monitor, train and advise staff in their work, acting as an expert resource on a specific topic if necessary. They supervise and line-manage staff, conducting appraisals when needed, and have skills in motivating and guiding their team. They can assign work appropriately depending on the interests and skills of individuals, so as to maximise the effectiveness of their team. They can oversee the activities of other staff members, identifying knowledge gaps and encouraging training if needed. The individual understands the different needs and management styles available and adapt appropriately to less experienced staff.
Supervision and mentorship requires good interpersonal skills, the ability to give clear instructions and feedback, and project management skills so as to assign tasks appropriately.
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Abilities
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Related competencies Similar tasks: Project management; Human resources; Creating or delivering training Required skills: Strategic leadership; Interpersonal skills
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4- Resources management
Competency Definition: The individual ensures that all applicable essential documents and trial records existence are accurate, complete, kept up-to-date and maintained – especially for those required by law and/or vital to the quality assurance of the study. They appropriately store and maintain restricted access to documents, where applicable.
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Abilities
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Related competencies Similar tasks: Determining liability and insurance needs; Securing or maintaining approvals; Securing or maintaining contracts; Closing study (archiving); Reporting Knowledge base: Good Clinical (or other) Practice; Research regulations Required skills: Record-keeping |
Competency Definition: The individual supports the research process by managing logistical tasks and ensuring the infrastructure and facilities are in good working order. They are able to plan, coordinate, track and reorder the resources and generic supplies for the study. They maintain equipment inventory, prepare and perform trouble-shooting on assigned material (electronic devices, equipment and reagents in the laboratory, etc.).
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Abilities
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Related competencies Similar tasks: Initiating study; Finances management Required skills: Organisational skills; Record-keeping |
Competency Definition: The individual has an awareness of study budget and understands how to operate research projects within financial constraints. They manage the study budget, including preparing financial reports and cost forecasts. They keep accurate, up-to-date accounts, and assist in ensuring timely payments for stakeholders. They are involved in budget negotiations, and in preparing the associated funding agreements between groups. Managing financial resources requires good study tracking, record-keeping and organisational skills, including the ability to plan and operate within given limitations.
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Abilities
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Related competencies Similar tasks: Attracting funding; Securing or maintaining contracts; Tracking study progress; Overseeing essential documents Required skills: Organisational skills; Record-keeping |