What are the competition categories and which one best suit my talents?
The competition categories are specially designed by the Executive Steering Committee to cater for professional working in Clinical Research. The categories are reviewed on an annual basis and 2011 saw the introduction of the Clinical Team category.
The Executive Steering Committee have also introduced some new developments for 2012, including the separation of the Project Manager category into Project Manager working exclusively for a CRO and Project Manager working for a Pharma Company. This recognizes some of the different skill sets necessary for these roles. For a fuller explanation of the 6 categories for entry, take a look at the role descriptors provided.
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Study Nurse/Clinical Research Coordinator
As a Clinical Research Coordinator (CRC) you play an important role in the success of the study, with your primary responsibility, as with all clinical research professionals, the protection of research subjects.
Your responsibilities will include, but are not limited to: coordinating and conducting the clinical trials while following ICH/GCP standards at investigator sites under the supervision of your Principal Investigator. You act as the point of contact for all involved with study including the Institute, Subjects and Sponsors.
Your likely responsibilities will include recruiting subjects from clinics, databases other hospital/institute departments, scheduling appointments, screening patients, following subjects, meeting with monitors (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. You will be experienced in handling all regulatory processes for the study from start to finish. New CRA (less than 4 years)
As a Clinical Research Associate (CRA) your professional role is defined by Good Clinical Practice under ICH/GCP. Your primary responsibility is to monitor clinical trials, ensuring compliance with the clinical trial protocol, SOPs and ICH/GCP. The protection of research subjects and the validity of the data during the course of the trial are central to your role.
You responsibilities will include the recruitment of potential investigators, clinical trials management of site performance and subject recruitment and you will be the main line of communication between the sponsor company and the investigator site. Experienced CRA (more than 4 years)
As an experienced Clinical Research Associate (CRA) your primary responsibility is to monitor clinical trials, ensuring compliance with the clinical trial protocol, SOPs and ICH/GCP.
In addition to your primary responsibilities your additional experience may be drawn upon by senior managers to help mentor and train more junior CRA's or other members in your team.
The protection of research subjects and the validity of the data during the course of the trial are central to your role and is something your strive to impress on others through your leadership and mentorship. Project Manager - CRO
As a Project Manager working for a CRO with your sponsor/sponsors, you are responsible for the delivery of the trial in accordance with the agreed project deliverables. You may be working in a single trial with a single sponsor organisation, or multiple trials with more than one sponsor. In addition to your skills as a Project Manager, you are a key point of contact for the sponsoring organisation and so your skills as a communicator and bridge between the sponsor and your organisation are critical. Study Leader - Pharma
As a Study Leader employed by a Pharma Company, your responsibilities will include managing the project deliverables including quality standards, budget, and timelines, compliance with ICH/GCP and company SOP's.
You may be leading through an 'in-house' team clinical team and/or working in an oversight capacity with single or multiple Clinical Research Outsourcing organizations. Clinical Team
You know that team work is vital to the successful completion of a clinical trial and you want to test your skills against other highly motivated and capable teams. The Clinical Team category is for teams of up to five individuals and can be a mix of Sponsor, CRO, PI and Study Nurse or five colleagues working for a Pharma Company and/or CRO. Whatever the constitution, you have to perform together as a team under pressure, going head to head with 5 other teams during a one-day clinical trial simulation. You will learn about yourselves as a team and the winners will deserve the accolade US Clinical Team of the Year.
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