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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.
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