Lack of clinical research coordinator definition a problem for drug study sector

The role of clinical research coordinator is increasingly common in drug research, yet the skills required for the position and even the responsibilities have yet to be fully defined according to a news study.

The research – published in Contemporary Clinical Trials Communications – looked at the occurrence of staff competencies listed in clinical trials in the Medline, Current Contents and PubMed databases.

The key finding was that while study coordinators are seen as important, a standard definition of what a CRC does has yet to emerge.

“While the responsibilities of investigators, sponsors and clinical monitors are well defined by national regulations of clinical trials and international guidelines on GCP, the importance of the CRC position, their responsibilities and main tasks, have not yet been completely described.”

“Moreover,” the authors continue “the term data manager and study coordinator have often been used as synonyms for many years and this may have contributed to confusion and delay in CRC precise definition.”

Standardization

The lack of a precise definition could be a problem for sponsors, CROs and trial sties according to the authors who suggest using other staff to perform some of the functions of a CRC in an ad-hoc approach may generate confusion between different roles.

”The establishment of a clear job description, the involvement as central positions in the complex research machine, and the standardization and regulation of their job titles are essential to avoid CRCs migration towards the private sector and guarantee academic successful and high-standard quality research.”

The authors also warned that the lack of clear role boundaries is starting to foster dissatisfaction in the sector.

“The lack of a well-defined job position and scarce compensation on one hand, and the work overload generated by the continuous updating of regulatory procedures, without structured training and educational programs on the other, are probably the major causes of frustration and dissatisfaction reported from CRCs.”

The findings are in keeping with earlier research that referred to CRCs as the invisible hand in clinical research due to their wide range of responsibilities and the fact they are often the connection between sponsors, patients and administrative staff.

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