[Hiring] Clinical Research Associate/Sr. Clinical Research Associate @Parexel

Role Description

The Clinical Research Associate (CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards.

• Accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release).
• Safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP).
• Maintain investigator and site staff engagement and satisfaction.
• Enhance the company’s image with its external stakeholders.
• Responsible for the resolution of all protocol-related issues for assigned investigator sites.
• Work closely with the Site Care Partner (SCP) and other members of the study team in activities associated with the set-up, running and close-out of sites in a clinical trial.

Monitoring Responsibilities and Study Conduct:

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met.
• Serve as the primary point of contact for assigned investigator sites during study conduct.
• Interface with the study team as needed, facilitating information flow between members of the study team, vendors and assigned investigator sites.
• Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and safeguarding of patients.
• Attend investigator meetings when required (virtual or F2F) and provide enrollment support.
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities.
• Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit.
• Submit all required reports, documentation, updates and tracking within required timeframes.
• Identify and resolve investigator site issues within required timeframes.
• Resolve data queries within required timelines and conduct close-out activities within required timelines.
• Ensure adequate oversight of the investigational product at the investigator site.
• Support database release as needed.
• May undertake the responsibilities of an unblinded monitor where appropriate.

Clinical/Scientific and Site Monitoring Risk:

• Maintain thorough understanding of the product, protocol and therapy area.
• Interact with investigator site health care professionals to enhance the Sponsor's credibility and facilitate their clinical development goals.
• Support the study clinician in ensuring patient safety and providing clinical guidance to investigators.
• Drive Quality Event (QE) remediation, when applicable.
• Serve as a point of contact for audit conduct and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations.
• Minimum 2 years relevant experience in clinical research site monitoring.
• Must be fluent in English and in the native language(s) of the country they will work in.
• Ability to travel 60-80%.
• Valid driver’s license and passport required.

Education

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent.

Company Description

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.