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.

Abilities

  • 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.

Abilities

  • 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.

Abilities

  • 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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