Openings >> Clinical Research Associate
Clinical Research Associate
Summary
Title:Clinical Research Associate
ID:262001241
Location:Location is Flexible
Department:Global Clinical Development
Job Status:Full-time, Benefited
Description

Celerion is searching for a full-time Clinical Research Associate (CRA) to perform monitoring and site management activities for clinical trials, clinical investigations and other interventional or non-interventional studies.

Primary Responsibilities:
  • Clinical monitoring and site management for national and international clinical studies of phases I-IV
  • Regulatory activities with authorities, ethics committees and investigators
  • Project management support and in-house activities for clinical research projects
  • Sponsor communication and contact
  Knowledge/Skills/Education/Licenses*:
  • BA/BS degree in biomedical-related field, life sciences or equivalent field
  • Two years working experience in clinical research, as a CRA, Study Nurse or related profession preferred
  • One year experience in on-site monitoring preferred
  • Excellent oral and written communication skills in English
  • High level of organization, multi-tasking, judgement, and keeping to timelines
  • Profound knowledge of ICH-GCP and other relevant regulatory requirements
  • Flexible and willing to travel up to 70%
  • Anticipate & prevent problems.  Able to create backup plans
*Equivalent education and experience will be considered.

 EEO/AA M/F/Vet/Disability
 
Celerion is the leading global provider of outsourced early clinical research services.
Customers include the leading global pharmaceutical companies as well as a number of biotechnology and small to midsized pharmaceutical companies.   Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.  Celerion provides these services through three clinical research units with over 600 beds located in the US and Europe. In addition, Celerion provides clinical research services through partnerships with other clinical research units in North America, Europe and Asia.  Supporting our clinical work are two world class bioanalytical laboratories located in Europe and the US.  Celerion is unique from other leading CROs in that our sole focus is on first-in-man studies to clinical proof-of-concept, as well as clinical pharmacology studies to support product labelling, in contrast to other leading CROs who provide services from discovery to the market.
 

Services include:

  • Early Clinical Research and studies required to support product labeling
  • Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting)
  • Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules)
  • Drug Development Services (Regulatory affairs and drug development consultancy)
  • Global Clinical Development including global multi-site studies conducted outside of Celerion clinics
Celerion sites are located in North America, Europe and Asia as follows:
U.S.               Lincoln, Nebraska; Phoenix, Arizona; Philadelphia, Pennsylvania
Canada         Montreal, Quebec
Europe          Belfast, Northern Ireland; Zurich, Switzerland; Vienna, Austria; Berlin, Germany; Paris, France
Asia              Seoul, Korea; Singapore, Indonesia

 
This opening is closed and is no longer accepting applications
Powered by ApplicantStack