MSD Sr Clinical Research Associate CRA 

Portugal, Lisbon 

107515562

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.