Senior Clinical Research Associate

Location
Dublin (Hybrid model)
Contract Type
Permanent Full-time
Closing Date
November 4th 2021

Reports to:
Clinical Operations Lead

Key Requirements

  1. Biological/ life sciences, pharmacy, chemistry and/or medical or nursing background.
  2. Minimum of four years’ clinical research experience or equivalent.
  3. Proven leadership both in delivering on project goals and mentoring junior level employees.

Main Function(s)

  • Maintain knowledge of ICH-GCP, applicable regulatory requirements and guidelines, SOPs (Standard Operating Procedures), study protocols and study-specific procedures.
  • Leadership and coordination of CRA activities for assigned studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.
  • To proactively identify and resolve clinical project issues and participate in process improvement initiatives as applicable. Manage responsibilities, including monitoring activities, leading to successful execution of clinical studies.

Primary Responsibilities

  • Perform activities according to Cancer Trials Ireland and/or Sponsor SOPs (if applicable).
  • Interact with COM to evaluate project goals, resources and timelines.
  • Assist CPM with Project Management activities as required.
  • Review and assessment of study specific documents, development/review and assessment of country specific documents ensuring compliance with ICH-GCP, local regulatory and ethical requirements.
  • Develop and maintain strong working relationships with study stakeholders to ensure study timelines and targets are met.
  • Share knowledge of country and site-specific processes during the start-up of a trial and throughout to ensure compliance to the protocol can be maintained.
  • Perform site visits for every stage of a clinical trial- investigator and site selection visits; initiation; monitoring; close out.
  • Prepare reports of site selection, initiation, monitoring and close-out visits and follow-up on outstanding issues as per the study monitoring plan.
  • Perform monitoring and reconciliation of Serious Adverse Events (SAEs).
  • Assume a lead role within assigned teams and studies, acting as a trainer and mentor for other team members.
  • Communicate on study issues internally at Cancer Trials Ireland and/or with Sponsor (if applicable) and with Investigator and site staff.
  • Collect and maintain essential documents as required by ICH-GCP, Cancer Trials Ireland and/or Sponsor SOPs and regulatory requirements/ethics committees.
  • Prepare Regulatory Authority and Ethics Committee submissions if required.
  • Track clinical trial activities
  • Assist with training, mentoring and development of new and junior CRAs.
  • Meet regularly with the Clinical Project Manager for assigned studies to review/update on the status of studies regularly and upon request.
  • Input into SOP development where appropriate.
  • Contribute to preparation for audits and inspections as required.
  • Organise, participate in and present at meetings and discussions with other teams and team members.
  • Perform other tasks as specified by Line Manager.