Categories

The competition categories are reviewed annually by the Executive Committee to ensure we are reflecting the span of skills and competencies that make you so great at what you do.

It is important that you look at the role description and not just the category titles because titles vary from company to company. We want to ensure you get the maximum benefit from participation by matching you with fellow participants with similar levels of responsibility.

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Clinical Research Coordinator

As a Clinical Research Coordinator (CRC) you play an important role in the success of the study. Your primary responsibility, as with all clinical research professionals, is the protection of research subjects through compliance with protocol requirements, applicable regulations and the standards of Good Clinical Practice. In addition, you serve in a critical role as the liaison between your site/investigator and the sponsor in delivering high quality research data.

Your responsibilities will include, but are not limited to, coordinating and conducting clinical trials while following ICH/GCP standards at investigator sites and/or institutions under the supervision of your Principal Investigator. You act as the central point of contact for all involved with each study, including your organization and the physician investigator(s), the sponsor/CRO and patient volunteers.

Other likely CRC responsibilities will include: developing and executing subject recruitment strategies; the enrolment of trial participants; following subjects throughout the trial to collect the necessary data; responding to the needs of clinical research monitors, project managers and other sponsor/CRO research team members; providing audit ready data to the sponsor/CRO; and ensuring that all regulatory-required study updates to both internal and external teams are accurate and timely.

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New CRA (less than 4 years' experience)

As a Clinical Research Associate (CRA) working within a Sponsor or CRO company, your role is defined by Good Clinical Practice under ICH/GCP. You perform a variety of clinical operations and monitoring activities including study planning, development, study conduct, closeout and post-study. Traditionally, CRAs visit and work with the investigative site staff to ensure proper study conduct, compliance with the clinical trial protocol, adherence to SOPs and ICH/GCP, and the timely generation and collection of quality data. The protection of research subjects and the validity of the data during the course of the clinical trial are central to your role as a CRA.

Your responsibilities include the recruitment of potential Principal Investigators, clinical trials management of site performance and patient recruitment along will being the main line of communication with the investigative site and the Sponsor or CRO company. In this New CRA category, you should have at least one year of actual monitoring experience.

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Experienced CRA (more than 4 years' experience)

As a Clinical Research Associate (CRA) working within a Sponsor or CRO company, your role is defined by Good Clinical Practice under ICH/GCP. You perform a variety of clinical operations and monitoring activities including study planning, development, study conduct, closeout and post-study. Traditionally, CRAs visit and work with the investigative site staff to ensure proper study conduct, compliance with the clinical trial protocol, adherence to SOPs and ICH/GCP, and the timely generation and collection of quality data. The protection of research subjects and the validity of the data during the course of the clinical trial are central to your role as a CRA.

Your responsibilities include the identification and recruitment of potential Principal Investigators, clinical trials management of site performance and patient recruitment along will being the main line of communication with the investigative site and the Sponsor or CRO company. As an experienced CRA, your responsibilities may extend to interviewing, training and mentoring New CRAs and other members on the clinical team.

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Project Manager

You are responsible for the delivery of the trial in accordance with the agreed project deliverables and may be working on a single trial or multiple trials across one or more geographic regions. The Project Manager category will cater for Project Managers/Clinical Trial Managers/Study Managers working in CRO or sponsor organizations.

Award

Company Team

The PharmaTimes Clinical Research Company Team of the Year is an award which will go to the winner of a team made up of 4-6 individuals from the same company or organization.

Award

Strategic Partnership Team

The PharmaTimes Strategic Partnership Team of the Year is an award which will go to the winner of a team made up of 4-6 individuals from two or more companies or organizations (CRO/Sponsors/Site/Vendors/Industry entities) with minimum of one member from each organization.

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