Study Nurse/Clinical Research Coordinator

The Clinical Research Coordinator (CRC) plays a significant role in the success of the research study.  The primary responsibility, as with all clinical research professionals, is the protection of research subjects.

Responsibilities will include, but are not limited to: coordinating and conducting clinical trials while following ICH/GCP standards at investigator sites under the supervision of the Principal Investigator.  The CRC acts as the point of contact for all involved with study: Institute, Subjects and Sponsors.

Although not inclusive CRC’s are responsible for recruiting subjects from clinics, databases other hospital/institute departments, scheduling appointments, screening patients, following subjects, meeting with monitors (the Pharmaceutical/CRO) and answering any queries that are generated during the monitoring visit and study, providing regular study status updates to both the internal & external teams. Handling all regulatory processes for the study from start to finish.

CRA/Site Manager (less than 4 years)

The Clinical Research Associate (CRA) is a professional defined by Good Clinical Practice under ICH/GCP.  The main function of a CRA is to monitor clinical trials.  The CRA ensures compliance with the clinical trial protocol, SOPs and ICH/GCP to ensure the protection of research subjects and the validity of the data during the course of the trial.

Responsibilities will include recruitment of potential investigators, clinical trials management of site performance and subject recruitment. The CRA will be the main line of communication between the sponsor and the investigator.

CRA/Site Manager (more than 4 years)

The Clinical Research Associate (CRA) is a professional defined by Good Clinical Practices under ICH/GCP.  The main function of a CRA is to monitor clinical trials.  The CRA ensures compliance with the clinical trial protocol, SOPs and ICH/GCP to ensure the protection of research subjects and the validity and accuracy of the data collected during the course of the trial.

Responsibilities will include recruitment of potential investigators, management of site performance, training of site staff to industry standards, liaising with investigators on conducting the trail and assisting the sites in developing subject recruitment strategies. This individual may also be involved in management of people (functional management).  In addition, this role acts as a coach/mentor for new or less experienced staff.

Trial Manager/Study Leader/Project Manager

The Trial Manager focuses on managing project deliverables, improving subject recruitment practices and ensuring compliance with SOPs and regulatory requirements.

Responsibilities are: to lead and manage study/studies including quality, budget, timeliness, overall study performance, continuous process improvement, and change management for global activities in assigned clinical trial(s). Responsible for all clinical trial activities from study start up through final close out visit ensuring organizational requirements are met.   They will manage multiple complex tasks requiring independent decision-making, time management skills, identification of potential conflicts early and utilization of high – value problem solving techniques  The Trial Manager must understand the Site Management roles and responsibilities.

Clinical Team (for up to 5 team members)

The clinical team finals will assess teams on their ability to work through a clinical scenario and also their ability to work together cohesively. The team can be up to five members and should have a range of years of experience with clearly articulated roles and responsibilities from across the clinical trial lifecycle. Dependant on your frame of reference a team could be comprised of internal and external partners.

Examples (not inclusive) could include - Study Co-ordinator, study manager, clinical scientist, study monitor or physician.

It is important to ensure that all team members are available for the finals and awards on 7 April 2011