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Clinical Trial Associate - Spain  

Celgene (company)


Posted on : 08 March 2017

Project Description

  • Under the direction of Clinical Research Associate director, this individual is responsible for providing in house support and assistance to assigned Study Teams and management staff. 
  • The CCTA will provide support to the Study Team during start-up, maintenance and close-out of clinical studies.  

 Responsibilities include, but are not limited to:
  •  Fulfill all responsibilities in accordance with company SOPs / WPs and policies.
  •  Develop and maintain a good working knowledge of FDA, ICH/GCP requirements and relevant local regulatory requirements. 
  •  Participate in and contribute to Clinical Research meetings, study related meetings, training activities and crossfunctional activities as appropriate
  •  Contribute to general departmental administration and the development and continuous improvement of departmental procedures. 
  •  Maintain and facilitate effective and productive communication and working relationships with all members of the department and staff in other functions. 
  •  Take personal responsibility for the quality of work, meeting required quality and performance standards and completing all assigned tasks in the most efficient and effective manner.
  •  Conduct additional tasks as may be required from time to time by the Clinical Research Director/Clinical Research Manager.
  •  Keep company Tracking databases up to date and enter study information into National Clinical Trial Database where appropriate.
  •  Design and maintain contracts & administrative tracking tools. 
  •  Support the production, coordination, completeness and accuracy of EC submissions in order to guarantee company studies are submitted and approved in a timely fashion (for studies monitored in house). 
  •  Customize contracts to local requirements as applicable. 
  •  Support/Perform Research Contract negotiations (in English & local language, where appropriate) with Hospital/Institution, Central Contracts & Out-Sourcing Group, and company’s Legal Group, to ensure local Start Up timelines are adhered to.
  •  Track Site payments to ensure timely payments are reflective of the contract’s schedule.
  •  Support Clinical Team (e.g. office or home based, and the contract CRAs) in administrative tasks and logistical support related to R&D Studies. 
  •  Manage study material and study supplies, as applicable. 
  •  File and maintain the study administrative files locally and send original documents to central TMF. When applicable, ensure electronic filing.
  •  Organize local Investigator Meetings, including agendas and minute production. 
  • Liaise closely with the CRAs, Study Managers team and CTAs.
  •  May conduct data query resolution and SAE information collection via facsimile, mail and telephone. 
  •  Manage local translators & printers for required local documents. 
  •  Distribute documents to investigational sites, ECs, or vendors as per requirements and distribute of communications and study documents to study teams. 
  • These might be single documents or packages and may be safety [submissions, safety letters (SUSARs), Investigator´s Brochures, or Annual Safety Reports] or study (listings, trackers, essential TMF documents) related.
  •  Participate in SOP and WP development and contribute to process initiatives as required
  •  Mentor and coach other CCTAs, as appropriate.
  •  Produce regular and adhoc Clinical Operations status reports as required. 
  • Perform all other related duties as assigned.
  •  Compliance with Quality and Environment Policies.
  •   Act according the Manual of Good environmental practices and segregate waste materials of the job properly.

Skills/Knowledge Required
Educational Background and Complementary Experience
  •   Degree in administration or relevant education or comparable operating experience.
  •   Advance in written and spoken English.
  •   Computer Literature: Good Knowledge at user level of Microsoft Office.
  •  Proficiency in Microsoft applications: Outlook, Word, Excel, etc.
  •   Good database and data manipulation skills/ knowledge.
  •   Knowledge of ICH / GCP and regulatory guidelines/directives.   

Work Experience 
 1+ year experience as a clinical Trial Administrator or in a Clinical Research & Development.