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Compliance In Focus
Posted by Paul Cobb on Mon, Sep 16, 2013

10 Signs That a Research Coordinator is Spread Too Thin

As a former research coordinator of five years, I am well aware of the extremely busy and10 Signs That A Research Coordinator is Spread Too Thin highly demanding nature of the job. In addition to balancing multiple trials, subjects, physicians, sponsors, and monitors; coordinators are often required to perform a diverse set of tasks that go beyond the scope of subject visit conduct. This may include regulatory submission and maintenance, laboratory processing and shipping, subject recruiting, and source document creation among others. Furthermore, coordinators often work to facilitate trials across multiple locations and must ensure that studies are conducted in accordance with applicable federal regulations, the investigator agreement or 1572, the protocol, and the rules of the IRB (FAIR SHAKE). Given the multitude of responsibilities, some coordinators may be spread too thin.

10 Signs That A Research Coordinator is Spread Too Thin:

  1. Inability to maintain accurate and complete source documentation – The subject binders may be missing pages, visits, procedures, appropriate signatures, or simply are not filled out. In other cases, subject binders may lack consistency in terms of adverse events (AEs) (e.g. documented in one place but not another), concomitant medications, or other study data.
  2. Difficulty entering data and/or responding to queries in a timely manner – Data may be overdue or the coordinator may be scrambling to enter visits as the monitor is arriving on site. In more severe cases, subjects may be enrolled and complete follow up visits prior to any data being entered. This can prevent the sponsor from tracking subject enrollment and may also violate the pre-arranged time-line for data entry outlined in the agreement between the sponsor and investigator. Queries can quickly accumulate and excessive unresolved queries are often a sign of an over-worked coordinator.
  3. Failure to use correct and updated study documentation – This includes use of outdated or incorrect versions of the informed consent document, protocol, source documents, and in some cases lab kits. The coordinator may not have started using the updated versions of study materials prior to a subject visit. This is also seen at sites which fail to have currently enrolled subjects sign revised versions of informed consent documents (when instructed to do so by the IRB).
  4. Adverse events have not been properly documented, entered, or reported – AEs may not be correctly signed off by the investigator, captured on AE logs, or entered on the case report form (CRF). In addition, AEs may not be correctly reported to the sponsor and/or IRB.
  5. Study devices or investigational medication are not properly processed in terms of receipt, storage, or product log completion – Receipt of investigational devices or medication may not be properly registered or acknowledged, storage may not be adequate or secure, and product logs may not be updated to reflect on-site inventory or current subject use.
  6. Delayed response to outstanding action items or other sponsor/CRO requests – Action items which require site assistance may not addressed or completed in a timely manner. This includes regulatory issues, data issues or queries, and other miscellaneous items requiring site follow-up.
  7. Site is unprepared for monitoring visits – Outstanding items/ issues from the previous monitoring visit have not been addressed adequately or completely. Regulatory and /or subject binders may not available or up to date. In some cases, the coordinator or site staff may be unaware of the monitor’s visit or not have dedicated sufficient space or resources for the monitor.
  8. The coordinator does not have sufficient time to spend working with the monitor – The coordinator may be unavailable or not have time to address monitor questions or action items. Furthermore, the coordinator may be unable to provide the monitor with requested study documentation or materials.
  9. Salient or recurring protocol violations – Protocol violations that indicate a lack of familiarity with the protocol or insufficient time to properly conduct the study. In addition, repeated violations of the same nature may suggest a lack of oversight on the part of the research coordinator.
  10. Incomplete or missing training documentation – Training documentation may be incomplete or absent. If training has occurred, the documentation will need to be located and filed. If training was not completed, appropriate members of the study team should be notified to complete the training.

Have you ever worked with a research coordinator who was spread too thin?

Perhaps you yourself were the coordinator. Please share your thoughts below. 

Photo Credit:Tom Morris

Giving Your Studies a Fair Shake

Topics: Research Coordinator, Clinical Research, Regulations


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