Working with clinical research coordinators
Medical writers and clinical research coordinators bring complementary skills to study documents and reports. Their collaboration connects the practical running of a study with clear protocols and publication-ready writing.
The coordinator's role
Clinical research coordinators are distinct from clinical research associates, although the roles are frequently confused. Coordinators conduct clinical trials according to good clinical practice under the principal investigator's immediate supervision. Responsibilities identified for Italian coordinators in 2004 included preparing independent ethics committee documentation, writing mid-term study reports and collaborating on the study protocol. In 2014, the president of an Italian coordinators’ association described preparing all study documents before ethics committee submission as a requirement for coordinators in Italy.
Coordinators' organisational and managerial skills cover practical aspects of protocols, including case report form design, pharmacovigilance reporting and compliance with applicable and local regulations. Medical writers contribute knowledge of publication quality standards and clear, concise writing for an international readership.
Collaboration and training
In Italy in 2014, reduced research resources were reported to increase pressure on coordinators to combine theoretical and practical protocol-development skills with English, information technology and medical writing. Research funding was particularly limited for investigator-initiated trials, making integration of professional expertise necessary to optimise budgets.
An experienced Italian coordinator recommended involving medical writers from the start of an editorial project or early in protocol development, rather than only at the proof stage. In her view, combining the two professions' skills would improve cooperation.
Coordinators may be asked to revise manuscripts for submission while recognising linguistic awkwardness but feeling unqualified to express changes that could affect scientific content. Medical writing training was recommended to help coordinators develop a coherent view of the project, produce clearer protocols and use writing tools and strategies such as abstract writing.