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.

Abilities

  • 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.).

Abilities

  • 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.

Abilities

  • 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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