[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 Pfizer 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
• Resolving 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.

Qualifications

• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Monitoring Experience: Minimum 1 year relevant experience in clinical research site monitoring and management
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience preferred
• Fluency in English and in the native language(s) of the country they will work in
• Valid driver’s license and passport required

Requirements

• Significant travel (60-80%) within area is required; may require some international travel and some weekend travel
• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details
• Demonstrated knowledge of global and local regulatory requirements
• Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)
• Demonstrated knowledge in disease and technical areas pertaining to clinical studies
• Demonstrated ability to support sponsor regulatory interactions/inspections
• Demonstrated knowledge of the processes around protocol design and feasibility assessment
• Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery
• Ability to work in a matrix team environment with the ability to influence, drive/lead and work through others for successful delivery of clinical trial
• Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation
• Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization

Benefits

• Full benefits
• Sick time
• 401K
• Paid holidays
• Paid time off

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.