[Hiring] Clinical Research Associate II/Senior 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. The CRA is accountable for:

• Site management and monitoring
• Managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release)
• Safeguarding the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP)
• Maintaining investigator and site staff engagement and satisfaction
• Enhancing the company’s image with its external stakeholders
• Resolution of all protocol-related issues for assigned investigator sites

The CRA will 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.
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock.
• 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.
• 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.
• 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.
• Support the study clinician in ensuring patient safety and eligibility.
• 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.

Qualifications

• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
• Minimum 2 years relevant experience in clinical research site monitoring.
• 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