Senior Clinical Research Associate, Phase I Oncology

This is a fully remote position, open to applicants in Texas.

📋 Description

• The Senior Clinical Research Associate (Sr. CRA) oversees site management, monitoring, and the closure of designated clinical trial investigator sites, ensuring patient safety and quality study execution in line with current laws, Good Clinical Practices (GCP), and the Sponsor's standards.

• The Sr. CRA is responsible for site management and monitoring, fostering relationships with investigator sites to ensure the effective execution of clinical trials (e.g., enrollment, database release), maintaining site quality (e.g., patient safety, compliance with GCP), and ensuring the engagement and satisfaction of investigators and site staff, while enhancing the company's reputation with external stakeholders.

• The Sr. CRA addresses all protocol-related concerns for assigned investigator sites and collaborates closely with the Site Care Partner (SCP) and other study team members, as necessary, for activities related to the setup, operation, and closure of sites in a clinical trial.

• Ensure the proper execution of clinical trials following the Study Monitoring Plan (SMP) and relevant laws, GCP, and the Sponsor's standards to achieve project objectives, timelines, and quality.

• Manage operational elements for the implementation of clinical trial activities at assigned investigator sites from site activation to database lock, ensuring that relevant timelines and quality deliverables are met.

• During the study, act as the primary contact for assigned investigator sites, collaborating with and/or escalating to the SCP to guarantee the quality of site delivery.

• Collaborate with the study team as needed, facilitating the flow of information among study team members, vendors, and assigned investigator sites.

• Partner with the Site Care Partner to conduct investigator site development, coaching, and training of site personnel to ensure continued compliance with protocols and the safety of patients; provide protocol training and address protocol-related inquiries from investigator site staff when necessary, including discussions on known or anticipated operational and clinical trial risks.

• Offer enrollment assistance and ensure progress by addressing site activation and recruitment challenges from investigators. Collaborate with the Site Care Partner and the study team to define and support recruitment strategies at the site level.

• Conduct onsite, remote, or electronic monitoring as necessary for study site initiation, routine monitoring, and study site closure activities, ensuring compliance with the SMP, Standard Operating Procedures (SOPs), and addressing emerging issues and technologies.

• Monitor site-level adverse events (AEs) and serious adverse events (SAEs), working with the Drug Safety Unit and following up with investigator sites, as necessary, to resolve required information for SAE reports.

⛳️ Requirements

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

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

• Fluency in English and the native language(s) of the country where they will be working is required.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are mandatory.

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

🏝️ Benefits

• EEO Disclaimer: Parexel is an equal opportunity employer. Qualified applicants will be considered for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.