Über
The information below covers the role requirements, expected candidate experience, and accompanying qualifications.
We are currently looking for a highly skilled and motivated CRA to share our mission to execute clinical research in an innovative, efficient, high quality and compliant manner to improve and save lives around the world.
Responsibilities
Perform clinical study site management and monitoring activities in compliance with International Conference on Harmonisation – Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
Gain an in-depth understanding of the study protocol and related procedures.
Coordinate and manage various tasks in collaboration with other sponsor roles to achieve Site Ready.
Participate and provide inputs on site selection and validation activities.
Perform remote and on-site monitoring and oversight activities using various tools to ensure:
Data generated at site are complete, accurate and unbiased.
Subjects’ rights, safety and well-being are protected.
Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close‑out visits and record clear, comprehensive and accurate visit and non‑visit contact reports appropriately in a timely manner.
Collect, review, and monitor required regulatory documentation for study start‑up, study maintenance and study close‑out.
Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits and inspections and overall site performance.
Identify, assess and resolve site performance, quality or compliance problems and escape per defined Clinical Research Associate’s Escalation Pathway.
Manage and maintain information and documentation to timelines.
Qualifications
Bachelor’s degree (or above) together with at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO, or an associate degree, certificate or equivalent in a scientific / healthcare discipline together with at least 5 years of relevant experience in the healthcare field, including at least 2 years of direct site management (monitoring) experience in a bio / pharma / CRO.
Ability to travel domestically; 50% of working time.
Hold a valid driver’s license.
High sense of accountability / urgency. Ability to set priorities and handle multiple tasks.
Capable of leading and mentoring CRAs on process / study requirements.
Work effectively in a multicultural environment. Ability to establish and maintain relationships.
Fluent in English and excellent communication skills, including the ability to understand and present technical information effectively.
Flexible work arrangements: Hybrid. xcfaprz
Equal Opportunity Employer
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
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Sprachkenntnisse
- English
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