Location: Waltham, Massachusetts
Closing Date: 09 Mar 17
Type: Full Time
Salary (£): Competitive
Benefits: Full health insurance benefits that include health, dental and vision
The Clinical Project Coordinators/Associate Project Managers will be based in our office in Waltham, Massachusetts. The Project Coordinator manages the clinical projects ensuring quality of the services in accordance with contractual obligations, applicable SOPs, ICH/GCP guidelines and other applicable regulations.
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. We are currently recruiting for a team of staff (CTAs through to Project Managers) to join us for the start of an exciting suite of studies in the respiratory area. We also have a number of opportunities in other therapy areas and this is a unique opportunity to become part of a rapidly growing company.
The Clinical Project Coordinators/Associate Project Managers will be based in our office in Waltham, Boston.
Main Job Tasks
• Support the start-up activities such as site start-up, SRP collection, review and approval, ICF customization and approval, EC and RA submissions. Support the Clinical Research Associates (CRAs) during the conduct of the study and maintain the TMF
• Assist project teams in expedited study start. Collect investigator site regulatory documents and perform Quality Check prior to submission to EC, Regulatory Authority
• Negotiate Investigational Sites Contracts, Investigators Agreements and the study payments related to them. Communicate actions between Investigational sites, investigators, Lead and the CRAs involved in the study to ensure that the timelines are met during the course of the clinical trial. Maintain knowledge on country requirements
• Arrange and track payments related to investigational site contracts
• Maintain internal investigator DB and study files for the duration of the study
• Assist with QC/audit of central files and liaise with Quality Assurance personnel as required.
• Maintain tracking systems, tracking progress of start-up activities to ensure initiation visit deadlines are met
• Organize process for obtaining translations as required
• Assist in the preparation of investigator / client meetings as required
• Collaborates with the project team on the preparation, handling and distribution of clinical trial supplies and maintenance of tracking information (logistics of the project)
• Assists with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
• May undertake some remote monitoring in support of the CRAs
• Support other clinical study activities as required to ensure that the clinical deliverables are met
Education and Experience
• Bachelor’s degree in scientific discipline
• Experience in clinical research and/or project coordination/management experience in the CRO/Pharmaceutical industry
• Good knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
• Experience working on a respiratory clinical trial is a plus!
• Knowledge of English and local language(s)
• Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
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