Are you a CRA ready for new responsibilities within an international environment? Do you get excited from sharing your knowledge and expertise to CRAs? Don't hesitate and apply today !
Job Description
The Lead Clinical Research Associate (Lead CRA) coordinates and supports site management and monitoring activities within the Site Management department of Clinical Trial Operations. The Lead CRA will lead the activities of the CRA team and is responsible for their delivery within budget, time and quality. The Lead CRA works in close collaboration with the Project Manager and acts as the main line of communication between the CRA team and other (sub) departments.
Responsibilities
Overseeing appropriate planning and tracking of monitoring visits
Review of site visit reports
Development of site management related documents (manuals, templates and tools)
Providing CRA specific guidance, training and coaching
Overseeing and managing site communications and site issues until resolution
Overseeing centralized and risk based monitoring activities
Managing study progress relative to enrollment and monitoring
Developing subject recruitment and retention strategies
Provide project oversight support, including:
Protocol deviations and non-compliances/issues
Safety reporting
Perform site management and monitoring activities
Review of study specific documents upon request by other sub departments, eg protocol, Patient Information Forms, and eCRF guidelines
Participate and present at Investigator Meetings and Kick-Off Meetings
Coordinate and provide support for study related (site) audits & inspections
Contribute to evaluation of site monitoring KPIs/metrics through regular review and reporting of findings to Site Management Director team. Support in setting up corrective action plans where needed.
Report to the Director Site Management and to the Project Manager
Actively support site management staff learning & development within the company
Perform Co-monitoring visits
Supervise and guide CRA trainees, CRA I, CRA II and/or SCRA
Assure good communication and relationships with (future) clients
Contribute and take part in client evaluations, visits and bid defenses
Requirements
Life science, healthcare, medicine and/or related degree
Minimum 4 years of CRA experience
Minimum 4 years of experience in drug development and/or clinical research
Thorough knowledge of ICH-GCP, privacy legislation (GDPR and/or HIPPA), regulations (CTR/CTD and/or CFR), and applicable local regulatory requirements
Good understanding of site management and monitoring
Demonstrated controlling, mentoring and supervising abilities
Strong written and verbal communication skills including good command of English language
Representative, outgoing and client focused
Ability to work in a fast-paced challenging environment of a growing company
Administrative excellence with attention to detail and accuracy
Proficiency with various computer applications such as Word, Excel, and PowerPoint required
Leadership skills
Strong organizational skills
Strong analytical, financial and problem resolution skills
Existing right to work in Europe required
Benefits
A balanced salary package based on your capabilities and experience, including extra legal benefits.
Vacancy number: 18553
