The Senior Clinical Research Associate (Sr. CRA) plays a vital role in overseeing the management and monitoring of clinical trial investigator sites. This position is focused on ensuring patient safety and high-quality study execution in line with current regulations, Good Clinical Practices (GCP), and the standards set by the Sponsor.

The Sr. CRA is responsible for:
• Managing relationships with investigator sites to facilitate the effective delivery of clinical trials, including patient enrollment and database readiness.
• Monitoring site quality to ensure compliance with GCP and maintaining the engagement and satisfaction of site staff.
• Resolving protocol-related issues in collaboration with the Site Care Partner (SCP) and other study team members, from site setup through to closeout.

Key Responsibilities:
• Ensure the proper conduct of clinical trials as per the Study Monitoring Plan (SMP) and relevant regulations to meet project timelines and achieve quality milestones.
• Act as the primary point of contact for assigned investigator sites during the study conduct phases.
• Collaborate with Site Care Partner to enhance compliance through training and guidance for site personnel regarding the study protocol.
• Attend investigator meetings and provide necessary support for participant recruitment efforts at the site level.
• Conduct both on-site and remote monitoring activities in accordance with established guidelines.
• Oversee adverse event reporting and support the Drug Safety Unit to ensure timely resolution of safety-related issues.
• Submit all required documentation and reports, ensuring adherence to timelines for Trial Master File (TMF) maintenance, protocol deviations, and study metrics.
• Identify and resolve site-specific challenges promptly, working with site personnel to develop corrective and preventative action plans.
• Monitor the handling and storage of investigational products at sites and ensure compliance with applicable regulations.
• Support database releases and may act as an unblinded monitor when appropriate.

Qualifications:
• Extensive knowledge of clinical trial methodologies, ICH/GCP standards, and applicable FDA and local regulations.
• A minimum of 3 years of relevant experience in clinical research site monitoring, ideally with 2 years specifically in Oncology.
• Preferred therapeutic experience in areas such as Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
• Fluency in English and the native language of the country of operation.
• A willingness to travel 60-80% of the time, along with a valid driver's license and passport.

Education:
• Bachelor's degree in life sciences or a professional degree (e.g., nursing, pharmacy) or equivalent experience.

Parexel is an equal opportunity employer, welcoming applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.