Roles

There are many different types of roles within the clinical research environment. A brief description of some of the more typical roles, many of which we recruit for, is below. For more information, please contact the Phlexglobal resourcing team.

 

Clinical Project Assistant (CPA) An entry level role into the clinical research industry providing clinical and logistical support.
Clinical Trial Administrator (CTA) Provides full clinical and logistical support and is involved in supporting most activities required to set-up, conduct and complete a clinical trial, working to ICH GCP, EU Directives and company Standard Operating Procedures (SOPs).
CTA Managers Recruit, manage, coach and develop the CTA resources in their team. 
Clinical Research Associate (CRA) Responsibility for all clinical aspects of the clinical trial and drug development, with a focus on the Investigator site, including the ability to set-up, conduct and complete a study, working to ICH GCP and company SOPs.
Clinical Research Managers Responsibility for coaching, recruiting, managing and developing study teams, and their projects.
Project Manager / Study Manager Co-ordinates and manages clinical research studies and staff to ensure all timelines and targets are met and costs are kept under control. 
Clinical Study Support Specialists
 Provide specialist clinical and logistical CTA support.  This role requires extensive experience as a CTA, including hands on experience of every stage of the critical path of a clinical trial. 
Document Administrators/Managers
 Provide tracking, document preparation, indexing and filing support to Document Management projects.
Indexing Specialists
 Responsible for the indexing of Trial Master File (TMF) documentation e.g. Case Report Forms (CRFs), protocols, internal and external correspondence, submissions to Regulatory Authorities, Clinical Trial Supplies, Investigator Brochures and other study specific documentation.
Study Archivist Assists in the provision of the Investigator and Sponsor archiving services in accordance with appropriate regulations and company Standard Operating Procedures (SOPs).
Statistician
Responsible for all statistical aspects of a clinical trial, including design, analysis and reporting.
Clinical Team Leaders Leader of the clinical element of a project, with responsibility for achieving delivery of milestones of the clinical component of the project in accordance with budgets and timelines ensuring maximum efficiency and profitability.
Drug Safety Associates
Responsible for receiving and assessing Adverse Events from both clinical studies and marketed use.
Regulatory Associates Responsible for the production, assembly, document management and publishing of regulatory submission documents and reports. 
Medical Information Associates Provide a Medical Information enquiry service to customers to aid decision making and ensure safe, ethical and effective use of products.