CRA – Clinical Research Associate – Spain – Permanent

CRA

Job Type: permanent
Job Category: Clinical
Location: Unspecified
Salary: Competitive
Posted: 2nd December 2021
Ref: CRAESP

This is a search for a Clinical Research Associate

This mid-size Contract Research Organization (CRO) that has a massive global reach. We are a company that strives to deliver cost-effective, quick-to-market clinical services in today’s emerging marketplace. This company has one of the largest global footprints of any CRO today and we are committed to not only maintain our standard, but to continue to strengthen our presence even further. We offer a unique working environment with a global team culture, competitive salary and benefits package.

To ensure that Investigators are conducting clinical trials in accordance with international Regulatory and Ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH).   May be responsible for assisting the RA Department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications.

  • Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
  • Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
  • Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
  • Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
  • Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
  • Collect and review regulatory documents as required.
  • Prepare site visit and telephone reports.
  • Responsible for multiple projects and must work both independently and in a team environment.
  • May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.

Working Relationship:

  • Reports to the Clinical Team Leader, Clinical Research Manager or Clinical Operations Manager as appropriate.
  • Collaborates with the CTLs, LCRAs and PMs as needed.
  • Liaises with clients as requested by the PM.
  • Liaises with national regulatory agencies and competent authorities.

WANT TO KNOW MORE regarding this Clinical Research Associate opportunity???:

Hirons@barringtonjames.com

+44 1293 776644

LI: https://www.linkedin.com/in/helaina-irons-351670195/

Visit our other positions: https://barringtonjames.com/

 

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