The Senior Clinical Research Monitor (Sr. CRA) plays a pivotal role in site management, monitoring, and the closure of clinical trial investigator sites. Your primary focus will be to ensure patient safety and uphold quality study execution by adhering to prevailing laws, Good Clinical Practices (GCP), and the Sponsor's standards. This role demands effective management of site relationships to guarantee successful clinical trials, including enrollment and database release, while enhancing engagement and satisfaction amongst investigators and site staff.
Key Responsibilities:
• Oversee and ensure the conduct of clinical trials aligns with the Study Monitoring Plan (SMP) and all applicable laws and regulations to meet project goals and timelines.

• Manage operational aspects of clinical trial activities at assigned investigator sites from activation to database lock, ensuring adherence to relevant timelines and quality standards.

• Act as the main point of contact for assigned investigator sites, maintaining a partnership with the Site Care Partner (SCP) to uphold site delivery quality.

• Facilitate effective communication between the study team, vendors, and investigator sites, ensuring information flows efficiently.

• Collaborate with the Site Care Partner to develop and train site personnel, ensuring compliance with study protocols and safeguarding patients.

• Attend investigator meetings and provide necessary support for patient enrollment, addressing site activation and recruitment challenges proactively.

• Conduct onsite and remote monitoring as required for site initiation, routine monitoring, and closure activities in line with the SMP and SOPs.

• Monitor adverse events (AEs) and serious adverse events (SAEs), collaborating with the Drug Safety Unit when necessary to resolve reporting issues swiftly.

• Complete all documentation, updates, and reports within required timeframes, including Trial Master File (TMF) documents, site reports, protocol deviations, and study progress metrics.

• Identify and resolve any issues at investigator sites in a timely manner, developing corrective actions with site personnel as needed.

• Ensure oversight of investigational products, managing receipt, handling, storage, and destruction as per regulations.

• Support database release processes as necessary and may perform unblinded monitoring responsibilities when appropriate.

Qualifications:
• Extensive knowledge of clinical trial methodologies, ICH/GCP guidelines, and regulations set by the Food and Drug Administration (FDA) and local authorities.

• A minimum of 3 years of site monitoring experience in clinical research, preferably with at least 2 years in Oncology.

• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

• Fluency in English and the native language of the working country is essential.

• Willingness to travel 60-80% is required, along with a valid driver's license and passport.

Education:
• Bachelor's degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or a medical background.

Parexel is proud to be an equal opportunity employer and aims to create a diverse environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.