Research Operations Area

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- Data flow

Competency Definition: The individual has a full awareness of the database requirements for a trial, including verification and query systems and audit trails, and how this can be achieved practically. This involves applying both practical IT knowledge to create the physical database and theoretical knowledge of the CRF and data analysis plan in order to integrate appropriate requirements and specifications. The individual can programme, test and implement an appropriate data management system, including using various devices for electronic data capture (e.g. PDAs, smartphones). They manage and trouble-shoot the physical infrastructure of the database, as well as the software interface and the data itself. They must also pay attention to aspects of security of data, in particular during data transfer or archiving. 

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Competency Definition: The individual understands the data collection, data entry and verification process. They recognise the importance of accurate and comprehensive source documentation, and of verifying this information before it is entered into the database. They are able to spot issues such as out-of-range values. They coordinate or otherwise participate in the data entry process, ensuring that reported trial data are accurate, complete, and verifiable from source documents. They can coordinate and produce data queries, keeping appropriate records of their findings and resolutions, and raising concerns when necessary. They recognise the need for confidentiality, and understand the relevant guidelines pertaining to this. 

Data may be collected from a range of sources including CRFs or health questionnaires that data collectors should be familiar with and able to appropriately fill in or retrieve information from, e.g. if the data has been directly generated by an electronic source. Collectors may work in the laboratory, or directly at the bedside.

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Competency Definition: The individual manages the data process in the trial; they oversee the flow of data and the specifications for its regular backup and safe storage, in line with ethical requirements and respecting participants’ confidentiality. They operate the data management system (DMS), and execute quality management strategies for the data. They check the timely resolution of database queries, and review reports generated from the databases as required. Data management requires excellent knowledge of the data flow plan, processes and guidelines, and good project management skills.

Expert: Experts may work with other sites to implement data management solutions during multicentre trials, and support the improvement of the data management process when necessary.

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2- Clinical & laboratory operations

Competency Definition: Clinical care relates to the theoretical knowledge of medicine and the ability to apply it during the research process, for example assessing clinical history, taking relevant measurements and samples, and providing appropriate and safe care and treatment. The individual may be involved in care in different ways: as a performer (conduct participants’ visits), as a coordinator (oversee or lead the clinical team) or as a controller (review participants’ medical records). The individual understands the differences between research and standard clinical care, and has a good understanding of the clinical field of study. The individual may also carry out data collection tasks that involve direct interaction with participants, such as administering health questionnaires or taking samples and measurements. They also deliver the intervention, monitor the participant for toxicity of the intervention, control adherence to treatment and provide emergency care in case of Adverse Event (AE).

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Competency Definition: The individual demonstrates an understanding of pharmacology and of the appropriate use of drugs, including investigational medical products (IMPs). They have knowledge of drug toxicity, pharmacokinetics and pharmacodynamics issues, and know how those should influence the clinical research process and participants’ clinical management. They apply their pharmacology knowledge to the IMP, ensuring safe use and dispensing of the IMP and of any appropriate comparators within the trial. They have a thorough knowledge of Good Manufacturing and Pharmacy Practices, and understand how to ensure the drug contains the appropriate active compound, especially in settings where counterfeit drugs occur frequently. They may assist in study design and implementation by providing pharmacological advice on the IMP and the comparators (placebos) to be used.

The individual also understands the importance of pharmacovigilance, both throughout and beyond the study lifecycle, and suggests steps to continually monitor drug effects in both situations.

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Competency Definition: Biomedical products may be participants’ biological samples (e.g. blood, tissues) as well as drugs or other medical devices used for treatment, and this competency relates to the ability to source, track and process these products safely and carefully within the trial environment. 

The individual has a good understanding of the requirements for storage, handling and tracking of the relevant biomedical products. They develop systems to handle these products appropriately, ensuring correct labelling and storage temperatures are maintained and documented. They ensure that they have the correct and completed paperwork for any samples taken and received.
Handling biomedical products require logistical skills (e.g. inventory and ordering of drug supplies, dealing with export/import permits) as well as technical knowledge (e.g. conditions for transport and storage, processing and reconstitution on receipt if applicable). Within the context of clinical trials, it also requires record-keeping skills as products need to be tracked, e.g. to identify participants from which a sample was taken or to ensure the drug labelling is made according to the code in blinded trials.

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Competency Definition: The individual uses lab equipment to conduct routine diagnostics for the trial, and can interpret and document the results appropriately. Performing laboratory operations requires scientific background knowledge (e.g. to interpret biological tests) and record-keeping skills.

Expert: The individual is also able to plan and set up new procedures and techniques within a laboratory.

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3- Interaction with the public and participants

Competency Definition: The individual understands the importance of community engagement in research activities and can design an appropriate community sensitisation strategy, adapting as required depending on the location and the needs of the study. They understand that different activities may be required at different sites for multi-centre studies, according to local variations. They can set up a Community Advisory Board, and know when to contact key opinion leaders and community chiefs or elders. They must ensure good communication is established in order to enable research/create a favourable context for research. Engaging with the community requires strong interpersonal skills and a good understanding of the area and culture where the research is to be held.

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Competency Definition: The individual who recruits and retains participants will be involved in outreach activities (informing potential participants about the study), screening potential participants (e.g. by administering health questionnaires for eligibility check), and executing strategies for retaining randomised participants. 

The individual needs a good understanding of the means for enrolling subjects in the trial, including the inclusion/exclusion criteria and participant recruitment strategies. They can manage participant recruitment, track figures and suggest trouble-shooting actions when recruitment figures are not met. They coordinate the visit schedules of participants in the trial, assisting in the follow-up of individuals and retention strategies, and monitoring withdrawals. They understand the importance of using local languages to interact with participants, and ensure the research team is equipped with translators if needed. 

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Competency Definition: The individual is aware of the legal requirement to gain and maintain informed consent for participants in a trial, and of the reasons for doing so. They explain the study in ways a potential participant can understand, paying attention to factors that can influence decision-making. The individual uses their excellent interpersonal skills and communication skills to deliver information about the study in a clear, accessible, non-technical manner, and can use creative means to explain difficult concepts (e.g. using illustrations when necessary). They are particularly sensitive to the requirements of vulnerable participants, and know when an impartial witness is needed to ensure transparency and fairness of the process. They also document the informed consent suitably, e.g. by adding a copy of the form to the patient record.

Once initial consent has taken place, the individual maintains good communication with the participant and continues to support them to ensure they are happy to continue, and ensures that they understand visit schedules, instructions on IMP or daily diary use, and any other trial procedures. Advising may also involve delivering general health advice to participants and their relatives.

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