Senior Clinical Research Associate

Location
Germany
Salary
Competitive
Posted
04 Oct 2018
Closes
06 Mar 2019
Ref
896029-P
Contract Type
Permanent

Main Responsibilities:

  • Conduct all type of site visits (e.g. Feasibility assessment, Site Selection Visit, Site Initiation Visit, Monitoring Visits and Close-Out visit) and write reports and follow-up letters within the timeframe agreed at study start
  • Attend CRA and Investigator meetings; if required, assist with training of investigative site personnel in GCP and local regulations and ensure sites are conducting clinical research according to the protocol, local regulatory requirements and other appropriate regulations
  • Attend and participate in study team meetings/teleconferences as well as country meetings/teleconferences; ensure information in the Clinical Trial Management System (CTMS) is up to date
  • Identify/evaluate potential Investigators for future studies; build effective and positive relationships with Investigators
  • Assist in the preparation for site audits and inspections and in responding to any issues identified within the timeframe specified
  • Keep medical and clinical knowledge for assigned therapeutic areas up to date; mentor/coach new CRA’s, and maintain annual training records
  • Audits/Inspections: Support in responding to company, client and federal regulatory requirements/audits, Respond to audit findings
  • Support the Clinical Monitoring Manager in all aspect of his/her responsibilities, as required
  • When monitoring outsourced to a Clinical Research Organization (CRO):
  • Support the Clinical Monitoring Manager in the management and oversight of the CRO
  • Perform site visits with the CRO-CRA (in Europe, if necessary also in specific countries outside of Europe) to ensure protocol and procedures are correctly understood
  • Perform Site Quality Visits (in Europe, if necessary also in specific countries outside of Europe) as outlined by the Clinical Monitoring Manager
  • Support the study team in resolving quality issues linked to monitoring deliverables
  • Perform spot checks of monitoring visit reports, TMF documentation or any other document/activity as defined in the oversight plan, if requested by the Clinical Monitoring Manager

Qualifications and Experience:

  • University degree in Biological Science/Pharmacy/Nursing or qualification in Nursing
  • Minimum of 5 years' CRA experience or combination of CRA and other clinical research relevant experience
  • Position requires international travel (50 – 60% travel time)
  • Knowledge of the Clinical Development process
  • Proficient knowledge of regional healthcare environment.
  • Excellent knowledge of International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines and applicable local regulations
  • Experience in working with electronic data capture, electronic Trial Master File (eTMF), and Clinical Trial Management Systems
  • Experience in participating in internal audits, external audits, and/or investigator site audits
  • Excellent verbal and written communication skills in English and German
  • Highly self-motivated and proactive, with a keen attention to detail
  • Goal oriented, able to effectively prioritize and execute tasks in a high-pressure environment
  • Ability to work in a cross-functional team environment
  • Strong interpersonal skills, excellent relationship-building and negotiation skills
  • Strong problem-solving skills and ability to manage multiple clinical project activities
  • Excellent organizational and time management skills as well as working flexibility

 

Should you be interested in the above position and wish to apply, please send your application with your CV, quoting the above reference number, to our recruitment team at recruitment@ctcresourcing.com

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