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- Safeguards
Competency Definition: The individual understands how to apply ethical theory in the context of clinical research design and operations. They understand the rationale and value of research, but can also balance its harms and benefits by taking into account participants’ interests. They are able to provide sound and poised review of the likely risks and benefits of a study to the participant, and to adapt this review based on the specific community and setting. They should particularly keep in mind populations which might be vulnerable in different ways, including children, populations living in low-resource settings or experiencing an emergency situation. On a daily basis, research staff and clinical professional must apply ethics and ensure that the confidentiality and privacy of the participant is respected at all times.
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Abilities
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Related competencies Tasks based on this knowledge: Developing a protocol; Risk and safety management; Engaging with the community; Enrolling and retaining participants; Supporting and advising participants throughout the informed consent process Similar knowledge: Good Clinical (or other) Practice; Research regulations Required skills: Cognitive skills; Work ethic
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Competency Definition
The individual understands the breadth of safety and risk issues that participants may face within a trial, and knows how to mitigate them. They fully understand the importance of relevant and timely reports during any type of safety breach, as well as standard safety reporting such as data safety monitoring (DSMB) report writing. They know how to handle adverse events putting participants at risk, including how to break the masking code in an emergency situation and how to ensure that participants will be providing care timely and accordingly. More broadly, the individual understands and manages risk throughout the study, and knows when to suggest actions to amend the study in view of current information and associated uncertainty and risk.
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Abilities
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Related competencies Tasks based on this knowledge: Developing study plans and documents; Analysing data; Controlling quality of research; Collecting accurate data; Providing clinical care; Ensuring appropriate use of IMPs; Reporting Knowledge base: Research methodology (randomisation and blinding); Good Clinical (and other) Practice Required skills: Cognitive skills
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Competency Definition: The individual understands the requirements for liability and insurance which may be required for different types of research studies, and knows the responsibilities of those involved (sponsor, investigator, funder), whether the study is commercial or non-commercial. They are able to plan and ensure appropriate cover for research projects, and report accordingly if claims are required.
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Abilities
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Related competencies Tasks based on this knowledge: Risk and safety management; Securing or maintaining contracts; Initiating study; Reporting Knowledge base: Governance and organisational context; Research regulations
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2- Quality Assurance
Competency Definition: The individual knows and understands the GCP guidelines (both from the International Conference on Harmonization and their local/national adaptations). They understand the importance of human subject protection in clinical research, and how application of the relevant GXPs seeks to ensure human subject protection and quality of research. They understand the necessity of applying GXPs (e.g. Good Clinical Practice, Good Pharmaceutical Practice, Good Laboratory Practice) to their work, and how to achieve this practically. They are careful to ensure participant confidentiality throughout the research process.
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Abilities
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Related competencies Tasks based on this knowledge: Developing the QMS and SOPs; Risk and safety management; Working as per the QMS; Controlling quality of research Similar knowledge: Ethics and human subject protection; Research regulations
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Competency Definition: The individual understands the importance of compliance with the protocol and study procedures to ensure quality of research; and acts accordingly on a daily basis. This task requires a thorough knowledge of the protocol, SOPs and quality management system. The individual should seek to attend protocol-specific training to enhance their understanding of the study. They understand how to apply the protocol knowledge and SOP guidelines to their day to day work, and how to report concerns such as protocol non-compliance. They ensure that there is a full set of up-to-date SOPs at their workplace, and coordinate the review and distribution of these documents when required.
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Abilities
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Related competencies Tasks based on this knowledge: Developing the QMS and SOPs; Controlling quality of research Knowledge base: Good Clinical (or other) Practice; Research regulations Skills required: Cognitive skills (attention to detail); Record-keeping |
Competency Definition: The individual understands the importance for quality control in research, and that monitoring is a tool to achieve this. They can take part in monitoring visits at sites, assisting others to resolve any discrepancies found. They understand the importance of documentation and record keeping, and as such keep clear reports of monitoring activities, findings and resolutions. They are able to plan a monitoring or quality control strategy, and coordinate the operationalising of it – which involves diverse activities such as checking source documentation or performing sites visits. Every individual involved in the daily activities of a study should ensure quality of research by consistently applying GXPs, complying with the protocol and to regulations, etc. Monitors will further ensure quality of research by performing audits.
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Abilities
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Related competencies Tasks based on this knowledge: Developing the QMS and SOPs; Risk and safety management; Working as per the QMS; Reporting; Overseeing essential documents; Collecting accurate data Knowledge base: Good Clinical (or other) Practice; Research regulations Required skills: Cognitive skills (attention to detail, problem-solving); Record-keeping |
3- Regulations & Governance
Competency Definition: Trial staff should understand the relevant submissions required (trial registry, regulatory, ethics, and any others such as national or local requirements), and contribute to or write the submissions. The individual coordinates and maintains the required submissions and provides appropriate updates, for example in the case of protocol amendments or for annual reporting purposes. Those in charge of maintaining approvals must be aware of the regulations that apply to trials and know how to submit applications to regulatory bodies. Reviewing authorities should ensure submission dossiers are complete and should provide an appropriate and timely review of those dossiers. They must keep written records of their decisions and respond clearly to investigators regarding those decisions.
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Abilities
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Related competencies Tasks based on this knowledge: Similar tasks: Determining liability and insure needs; Securing and maintaining contracts; Reporting; Liaising or acting as a link; Overseeing essential documents Knowledge base: Research regulations Required skills: Language and communication skills (writing); Record-keeping
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Competency Definition: The individual understands the importance of, and manages, binding agreements and contracts. These could be with individuals or with sites or subcontractors. The individual ensures that all the relevant contracts are agreed and that they are signed, stored, and updated appropriately. Securing contracts require good negotiation skills and a thorough understanding of responsibilities and liability within the clinical trial team. The individual should also be able to assess vendors and/or suppliers based on their claimed qualifications, experience, accreditation, etc. Contracts should define the distribution of roles, responsibilities and accountability within the contractors, and define the governance processes that apply.
Sponsor specific: Sponsors should consider legacy after trial closure (e.g. issues relating to access to drug for a wider public, including participants outside the trial).
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Abilities
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Related competencies Tasks based on this knowledge: Determining liability and insurance needs; Securing or maintaining approvals; Initiating study; Liaising or acting as a link; Overseeing essential documents Knowledge base: Governance and organisational context; Research regulations Required skills: Interpersonal skills (negotiation); Record-keeping |
Competency Definition: The individual has an understanding of the roles and responsibilities of staff within relevant organisations, both in terms of practical application to their day-to-day role and of governance. The individual understands the roles and responsibilities of organisations involved in the trial (e.g. sponsor, regulatory authorities, contract research organisation, other sites), how organisations relate to groups involved in a trial, and understand how their own site/group fits into this framework. They understand their own roles and responsibilities and how their job fits into the overall research project, who they must report to, and when delegations are required. They also understand where the research study fits within the wider scientific aims of their organisation and what plans should be put in place for the future distribution of the product would it be proven safe and effective. They ensure that others in the team understand their own roles and responsibilities, and work within this remit.
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Abilities
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Related competencies Tasks and skills using this knowledge: Determining liability and insurance needs; Securing or maintaining approvals; Securing or maintaining contracts; Human resources; Liaising or acting as a link; Strategic leadership Similar knowledge: Research regulations
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Competency Definition: The individual has an understanding of the relevant guidelines relevant to their work, whether local policies, international guidelines or regulatory authorities requirements; and applies them to their work. They report appropriately, especially in the case of breach of abidance, and work with the authorities when required such as during audits. They understand fraud and misconduct during research and seek to address them. All staff should consistently abide by regulations, and some hold particular responsibility to check that the study meets regulatory requirements, local policies, and applicable international guidelines.
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Abilities
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Related competencies Tasks using this knowledge: Developing study plans and documents; Controlling quality of research; Securing or maintaining approvals; Securing or maintaining contracts Similar knowledge: Governance & organisational context
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