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.


  • Review protocols and conduct feasibility planning, risk assessments

  • Recruit study teams, Quality Control teams, and oversight committees such as steering committee

  • Plan and coordinate study initiation process (initial requirements in infrastructure and facilities, supplies, staff, training, etc.), in particular laboratory and pharmacy start-up activities

  • Conduct site and investigator selection: identify, visit and recruit suitable sites, identifying training and technical assistance needs

  • Test, document and pilot risk and mitigation strategies, such as code breaking procedure in emergencies (piloting)

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

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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.


  • Perform study close out visits at sites, and audit as required

  • Plan and coordinate data and source document archive for specified time period

  • Maintain study documents archive inventory, and make arrangements for (selected) access to files after close-out

  • Ensure unused trial supplies are accounted for, and appropriate disposal of trial materials once research is completed

  • Send notifications of closures: inform and submit relevant reports to official bodies (regulatory authorities, EC, etc.) and to other people involved with the study (investigators, institution, trial subjects, etc.)

  • Ensure and oversee close-out activities in case of premature termination of trial

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.


  • Oversee study and site management, including managing multiple sites/laboratories and ensuring consistency

  • Oversee specified processes within the trial, e.g. recruitment, monitoring, follow-up

  • Plan work schedules and timelines, review associated reports

  • Coordinate or manage teams or CROs

  • Understand how to use project management processes and tools

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

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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.


  • Tracking; Progress; Milestones; Deadlines; Timely; Objectives/goals/targets

  • Understand project scope, milestones, budgets, timelines; track these appropriately

  • Track progress of study, using tracking tools or software if appropriate, and measures progress against planned objectives and targets

  • Use progress tracking to anticipate potential issues, so initiative can be taken for resolution

  • Ensure timeliness of reporting relevant milestones

  • Review status reports from other team members in relation to milestones

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

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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.


  • Report appropriately when required within the team (e.g. on workload, logistics, status of project); escalate issues or concerns appropriately

  • Write suitable reports according to audience, presenting information clearly

  • Understand specific and varying reporting requirements for diverse bodies (e.g. IRBs, sponsors, funders, regulatory authorities as opposed to trial management team, steering committees and safety monitoring boards)

  • Have responsibility for the quality, coordination, medical and otherwise scientific accuracy and timeliness of relevant reports

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

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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.


  • Understand the communication and liaison required as part of a trial; for example communication with the sponsor, with sites, with PIs, stakeholders, monitors etc., to ensure smooth and successful execution of trial activities

  • Liaise appropriately and regularly with the groups relevant to their role, keeping groups informed of progress, developments and issues.

  • Be able to act as primary contact for authorities, media, CROs, etc.

  • Process communications received and ensure a timely and complete response

  • Ensure that relevant documents are communicated with the team; for example that the correct version of the investigator’s brochure/ protocol is sent to groups, communicating amendments, etc.

  • Interact with staff in other functional areas to ensure the highest level of collaboration across groups

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

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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.


  • Organise meetings or teleconferences (ensuring correct attendees, making practical arrangements, preparing agendas, etc.)

  • Prepare for, participate in and present clearly at meetings as required

  • Take minutes, ensure they are reviewed and signed by the individual in charge

  • Chair the meeting; have appropriate Chair training

  • Facilitate meeting, ensuring agenda is kept to and decisions made

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

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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).


  • Recruit and select team, plan and coordinate their training as required

  • Ensure that individuals have received and understood instructions to conduct their work both safely and as per the protocol

  • Ensure the work environment is safe for staff, e.g. that laboratory equipment or infection control procedures are in place

  • Ensure that individuals are qualified for their role; hold CVs, training records and logs of delegation, and ensure they are updated when appropriate

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

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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).


  • Deliver effective training in front of groups, e.g. site training on study protocol/SOPs

  • Produce materials such as manuals or presentations for training on a specific topic, e.g. the data management system or participant flow

  • Be able to determine the appropriate subject topic, assess audience responsiveness to training, repeat and paraphrase source material (e.g. SOPs) in order to produce an effective training session

  • Deliver effective On-the-Job (OJT) or Individual training

  • Develop a training curriculum and/or manage a training programme

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.


  • Support and guide other researchers or a team and monitor their performance, developing their skills and capacity as needed

  • Mentor new staff; act as an technical advisor or expert to staff or researchers

  • Help and support other researchers (whether with work or personal issues, learning, etc.); provide comprehensive advice and guidance

  • Be aware of the various styles of supervision, and understand the principles of sound supervision/motivation techniques and their applications in the work environment 

  • Line-manage and conduct appraisals for staff

  • Supervise and coordinate the work of the team

  • Evaluate and assign work/delegate to others, based on an individual’s strengths and interests

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.


  • Ensure collection and maintenance of essential study documentation, e.g. up-to-date protocol, trial master file, site files, delegation logs, investigator’s brochure, official approvals, CVs, important correspondence

  • Update important documentation as required

  • Hold documents in a central location, filed in an organised manner and readily available for inspection

  • Maintain security of documentation by controlling access and physically protecting it from elements (e.g. water, fire)

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

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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.).


  • Coordinate the resources and supplies required for study, ordering things when required and within financial constraints

  • Create ways to plan, track and inventory study consumables

  • Plan logistics required for the trial materials, such as arranging shipments and accounting for materials

  • Equipment management: take care of and calibrate assigned equipment, perform basic trouble-shooting and report damages/required repairs

  • Space management: ensure appropriate facilities for study and clean environment

  • Specialist setting: Maintain a laboratory in running order by preparing reagents and disposing of biological and chemical waste appropriately

Related competencies

Similar tasks: Initiating study; Finances management

Required skills: Organisational skills; Record-keeping

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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.


  • Have an awareness of study budget and operate within financial constraints, and assist others in doing so

  • Manage study budget and forecasting

  • Alert relevant personnel to potential escalating consumable and other costs associated with a clinical research study

  • Assist in budget negotiations and funding agreements

  • Maintain accurate accounts, synthesise financial information from multiple sources to create report and ensure up-to-date financial information is available and circulated

  • Manage expenses, e.g. preparing invoices and work orders, cash float, travel expenses, participant reimbursements

Related competencies

Similar tasks: Attracting funding; Securing or maintaining contracts; Tracking study progress; Overseeing essential documents

Required skills: Organisational skills; Record-keeping 

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