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- Design & planning of research

Competency definition: The individual has enough knowledge of a specific area linked to health, either with a background in fundamental or social sciences. This knowledge enables them to understand the purpose, concept and topic of a study. They have an appropriate education or experience in health sciences dependant on their role, which they are able to apply daily to perform their research job appropriately (e.g. to provide clinical care or deliver the intervention to participants, to set clinical research questions or to analyse quantitative and qualitative data). They maintain their understanding and knowledge of new advancements in their specific field by engaging with the professional community, i.e. by attending conferences or seminars and by reading relevant articles.

  • Have sufficient scientific knowledge for their role, e.g. understanding of medical terminology or HIV issues if the role warrants it

  • Maintain up-to-date understanding in their area of expertise, e.g. pharmacology (pharmacodynamics and pharmacokinetics), epidemiology

  • Be an expert or solid reference on health sciences for the team

  • Contribute medical input into study designs and protocol

Related competencies

Tasks based on this knowledge: Developing a protocol; Analysing data; Disseminating research findings; Providing clinical care; Ensuring appropriate use of IMPs; Handling biomedical products; Performing laboratory assays

Similar knowledge: Research methodology

Required skills: Cognitive skills; Work ethic 

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Competency Definition: The individual has an understanding of the different types of research methods and study designs, the different sources of data (primary and secondary), and they recognise when each might be used. In particular, they are aware of methods that are being used in the study they are working in. They are also well aware of the processes within a clinical trial or research project and of how they differ from practice.

Expert: Following conduction of a comprehensive literature review, the individual recognises the gaps in current knowledge and can suggest a suitable and practicable research question. They are able to turn the question into a feasible and appropriate trial design, adopting appropriate randomisation and blinding procedures. They suggest appropriate measures to answer the research question (primary and secondary outcomes, endpoints, etc.). They have a deep understanding of statistics as they relate to research design, including issues of validity, reliability and power calculations. They can suggest adaptations to the design or make appropriate allowances depending on the risk and setting of the trial, thus facilitating the research without inhibiting the validity of the results.


  • Understand the importance of and how to access, critique and synthesize literature appropriately

  • Be aware of/understand the elements (statistical, epidemiological and operational) of clinical and translational study design; and different stages of clinical trials

  • Design an appropriate clinical trial, including: select a design for the research question, define outcome measures and endpoints, perform power calculations, design a randomisation and blinding system, etc.

  • Develop cost effective risk-based strategies to run clinical research studies effectively in low-resource settings

Related competencies

Tasks based on this knowledge: Developing a protocol; Developing study plans and documents; Developing the CRF and DMS; Analysing data; Initiating study

Similar knowledge: Health-related knowledge 

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Competency Definition: The individual understands the different elements of a research protocol. They can write and/or review a protocol which operationalises the chosen research design appropriately for the disease and the setting in question.

Developing the protocol (which may be a pre-clinical, exploratory or clinical study) requires writing skills, combined with the ability to use theoretical knowledge of research methods and scientific concepts. The protocol development spans from drafting to approval, via review and then continuous updating.


  • Be aware of the different elements that must be covered in a research protocol, including the specific requirements (e.g. regulatory, ethical) linked to the study type and/or setting

  • Draft an appropriate protocol

  • Contribute to relevant sections of a protocol

  • Coordinate protocol writing and review; track inconsistencies, errors or omissions

Related competencies

Similar tasks: Attracting funding; Developing study plans and documents; Developing the QMS and SOPs; Developing the CRF and DMS

Knowledge base: Health-related knowledge; Research methodology; Ethics and human subject protection; Good Clinical (or other) Practice; Research regulations

Required skills: Language and communication skills (writing); Organisational skills (planning)

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Competency Definition: The individual understands therequirements of different funding sources, and can write an effective grant application which ensures maximum chances of success. Budget and resource requirements are planned thoughtfully and accurately. Attracting the necessary funding requires the individual to identify sources for funding, and to understand the current interests of donor agencies and global health stakeholders. Based on that information, the individual is able to plan a relevant study which will be attractive to the grant call, to evaluate study costs and necessary supplies, and to write effectively and in a persuasive manner.


  • Have an understanding of major funding bodies, and that application requirements vary from one to another

  • Understand the component parts of a grant application process

  • Plan costings and resources for a grant application

  • Independently write or contribute to grant application

  • Seek to address funders’ interests by developing original grants

Related competencies

Similar tasks: Developing a protocol; Securing or maintaining contracts; Logistics and facilities management; Finances management

Required skills: Strategic leadership; Language and communication skills (writing)


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2- Protocol operationalization

Competency Definition: The individual has sufficient understanding of the protocol and research processes to make plans for, and write documents to support the conduct of the study. They can contribute to or independently write the informed consent forms or other trial documents, as required for their role. They can design appropriate and pragmatic plans in relation to their role within the trial; for example how to project-manage the whole trial procedure, how to design the consent process and participant flow, etc.

Developing plans and documents to support the study requires good writing skills together with a comprehensive knowledge and understanding of the study protocol, the constraints within which the study will be run (e.g. low-resource or particular cultural setting, infectious disease requiring constraining protection measures), with the ability to translate this high-level document into practical and reproducible operations.


  • Design overall operational plan for the study, e.g. project management plan

  • Design participant flow process, with visit schedules, appropriate documentation and time-points for sample taking, etc.

  • Design study processes related to ethics, such as community sensitisation plans, participant information leaflets, recruitment strategies and informed consent form

  • Design practical communication plans to circulate information within trial staff and to key stakeholders, e.g. participants groups

  • Coordinate/Contribute to the writing of study documents, such as information leaflets for participants

Related competencies

Similar tasks: Developing a protocol; Developing the QMS and SOPs; Developing the CRF and DMS; Initiating study; Project management

Required skills: Language and communication skills (writing); Organisational skills (planning)



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Competency Definition: The individual has sufficient understanding of the protocol, of the practicalities of its execution and of the risks associated to the study to design a quality management system and risk-mitigation strategies. They develop a quality assurance plan in accordance with Good Clinical Practice guidelines in order to deliver the best-quality science and study. They understand how to take account of pre-study assessments (feasibility, risk and site assessment) to develop study-specific quality management plans. The QMS should include plans for audits at different sites and contractor organisations, if applicable.

The individual also understands the structure and requirements that SOPs must fulfil, and know how to write detailed, clear and pragmatic guidelines that will enable replicable performance of study activities between individuals, between sites, etc., thus enabling consistent execution of the QMS plan. Developing SOPs to operationalize study plans requires good writing skills together with detailed knowledge of the requirements of the organisation within which the individual is working and the standards it requires. 


  • Develop quality management systems for the whole study, and for specific sites, laboratories or pharmacies, where appropriate

  • Develop and write procedures for quality assurance, e.g. how to track participants’ information and check the accuracy of collected data without breaking confidentiality rules

  • Develop and write procedures to control compliance to protocol and SOPs on a daily basis and throughout the study

  • Design risk management and safety plans, e.g. adverse event reporting systems, safety management plans, etc.

  • Coordinate/Contribute to the writing or drafting of SOPs

  • Write SOPs that are both GCP and regulations compliant

  • Develop guidelines to ensure study procedures will be consistently applied and adhered to

  • Plan and translate the quality management system into pragmatic SOPs

Related competencies

Similar tasks: Developing a protocol; Developing study plans and documents; Developing the CRF and DMS; Risk and safety management; Determining liability and insurance needs; Working as per the QMS; Controlling quality of research; Initiating study; Project management
Knowledge base: Good Clinical (and other) Practice; Governance and organisational context; Research regulations

Required skills: Organisational skills (planning); Language and communication skills (writing) 


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Competency Definition: The individual has sufficient understanding of the study and of data management constraints to suggest practical means for data capture and to write documents to collect study data. In particular, they design a suitable Case Report Form (CRF) and/or questionnaires, taking account of the outcomes to measure, of the study endpoints, etc. They also develop plans for the overall data management process, including methods for reporting and monitoring the safety data. They must ensure the CRF and planned data management system (DMS) will enable acquisition of appropriate and high quality data in order to answer the research question.


  • Coordinate/Contribute to the writing of CRFs or source documentation forms

  • Develop health questionnaires

  • Design a data management plan for the study

  • Contribute to quality management systems for the study as they apply to data processes, such as monitoring of safety data and checking database requirements

  • Investigate potential data management systems for the study

Related competencies

Similar tasks: Developing a protocol; Developing study plans and documents; Developing the QMS and SOPs; Controlling quality of research; Creating and maintaining a database; Data management

Knowledge base: Health-related knowledge; Research methodology

Required skills: Language and communication skills (writing); Computer and IT skills

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3- Interpretation of study results

The individual can extract and analyse quantitative data using appropriate software, applying their knowledge of biostatistics, trial design and medicine to draw valid conclusions from the data and outline limitations. The analysis stage may involve some modifications of the data (e.g. creating graphs, calculating rates) to clearly present results. The individual is able to perform statistical monitoring and interim analyses if required, including to validate the data.

Data may also be qualitative, in which case the individual uses different software if necessary, and applies different knowledge related to social sciences methods to perform the analysis and draw accurate conclusions.

Data analysis and interpretation requires analytical thinking and IT skills of the relevant software.


  • Extract data from database and conduct data analyses using statistical software packages; e.g. compute rate, ratio and percent, interpret bar graphs

  • Identify and articulate whether or not any conclusions drawn from analyses of data are valid and based on the material provided

  • Perform statistical monitoring of data and interim analyses

  • Interpret efficacy and safety data from clinical trials

  • Specialist setting: Apply modelling and simulation knowledge using quantitative data and appropriate technology

Related competencies

Tasks based on this knowledge: Developing a protocol; Developing study plans and documents; Developing the CRF and DMS; Analysing data; Initiating study

Similar knowledge: Health-related knowledge

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The individual is aware of the importance of reporting the results of research, and of the various dissemination formats available for different audiences. They can clearly communicate results in writing and speaking, in a manner suitable for the audience. They take appropriate steps to feed results back to the local community, and are able to prepare lay summaries for research participants and the public. They are able to submit an abstract for a conference, and subsequently prepare a suitable poster or oral presentation (or assist others to do so). They understand the component parts of a scientific publication or final report, and can draft, coordinate and write one confidently.

Language and communication skills are of primary importance to disseminate findings, as is the ability to synthesise complex information to explain to others. The task may require coordination and managerial skills when the first author or leader is expected to collect contributions from various parties in their team.


  • Coordinate/Contribute to/Write a publication or final report

  • Be aware of the differing requirements and formats of journals

  • Be aware of the concept of plagiarism and of requirements for citations of others’ work

  • Write and submit abstracts to conferences or journals

  • Assist in the preparation of and/or deliver oral or poster presentations at conferences/meetings

  • Write, agree and work to a publication policy or dissemination plan

  • Develop communication and awareness programmes for results

Related competencies

Similar tasks: Analysing data; Closing study; Reporting; Facilitating or attending meetings

Knowledge base: Health-related knowledge; Research methodology

Required skills: Cognitive skills; Language and communication skills; Organisational skills


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