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Senior Clinical Research Associate

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Dublin
  • Sector: Science
  • Date posted: 17/10/2018
  • Job reference: BBBH90710

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Senior Clinical Research Associate

My client, a leading pharma organisation is currently seeking a Senior Clinical Research Associate to join their team for a 12-month contract opportunity. In this position you will be monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites. You will be responsible for site compliance for the study protocols and procedures as well as ensuring compliance to local regulatory requirements.

You will be will have the opportunity in this position to be responsible for overseeing all of Ireland clinical trial activities and be responsible for study progress.

  • Responsible for site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites within the approved Clinical Development Plan (CDP).
  • Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide quality data required for global regulatory submissions for approval of drugs.
  • Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
    • Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified and have suitable resources and facilities to properly conduct the study.
    • Ensuring Investigator Agreements and budgets are negotiated and executed for assigned study sites, and subsequently initiating payments at key milestones.
    • Training and supervising cross functional site personnel on study related procedures for the duration of the study.
    • Tracking to ensure enough resources at site to conduct study activities for duration of the study.
    • Tracking enrollment activities to ensure site remains on track with site commitments. Develops contingency plans to ensure site commitments are met.
    • Reviewing patient data at site to ensure safety of patient and patient data is consistent with what is reported in the case report form. Serves as liaison between Investigator and Study Medical Expert to resolve any medical patient-related queries. The data from these clinical sites are required to demonstrate patient safety and efficacy of investigational products which forms the basis of regulatory approval.
    • Assuring adequate control of investigational product (study medication), which includes: ensuring sites have met all local and legal requirements to receive investigational product, study drug storage, and continually ensuring patient compliance with expected study drug dosing. The Sr. CRA is responsible for study drug accountability at the site level and arranges for destruction of investigational product in accordance with local legal and regulatory requirements.
    • Ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.
    • Periodically reviews Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements.
  • Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug reactions. The Sr. CRA is responsible for training the Investigator and site staff on these strict regulations and procedures for timely reporting and as well as monitoring ongoing compliance.
  • Due to the highly regulated clinical trial environment, the Sr CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) Plans. The Sr CRAs ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
  • As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.
  • Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The Sr. CRA is a member of the audit/regulatory inspection team.

Key Requirements:

  • The incumbent must have a bachelor's degree (or equivalent) with 6 - 7 years of relevant healthcare experience including 4 years of monitoring & site management experience
  • in-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH - GCP, drug safety requirements, data management processes and investigator grant parameters
  • Effective written and verbal English communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills are required. In addition, the incumbent requires effective planning and organization skills, attention to detail and excellent follow through.

For more information on this and other potential opportunities please contact Kathryn on 016455250 or email

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