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MSD Sr Clinical Research Associate CRA 
Portugal, Lisbon 
107515562

14.07.2024

Job Description

The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. And also:

  • Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

  • Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents

  • Participates & provides inputs on site selection and validation activities

  • Performs remote and on-site monitoring & oversight activities using various tools to ensure that data generated at site are complete, accurate and unbiased

  • Subjects' right, safety and well-being are protected

  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required

  • Supports and/or leads audit/inspection activities as needed

  • Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

  • Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring

Requirements:

  • Master in Science (or comparable). Advanced degree (MD, PhD) possible but not required

  • Min. 4 years of direct site monitoring experience in a bio/pharma/CRO

  • Strong communication, educational/pedagogic, diplomatic and empathic skills

  • Strong organizational skills with demonstrated success required

  • Native Portuguese and fluent English

  • Problem solving and conflict resolution

  • Negotiation skills with both internal and external groups

  • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines

  • Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines

  • Hands on knowledge of Good Documentation Practices

  • Proven Skills in Site Management including management of site performance and patient recruitment

  • Demonstrated high level of monitoring skill with independent professional judgment

  • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices

  • Ability to understand and analyze data/metrics and act appropriately

  • Ability to travel at least 3 days per week.

Current Contingent Workers apply


*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.



A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.