At Parexel, we all share one goal: to improve the world's health. We take our work personally, do it with empathy, and are committed to making a difference. Parexel is now looking for an experienced Senior Clinical Research Associate or Clinical Research Associate II with solid Oncology On

- Site Monitoring experience to join us on the West Coast, US.

This is a remote-based role posted in California and involves frequent travel to investigator sites within the region. As a Sr. CRA, you'll be responsible for site management, monitoring, and close-out of assigned clinical trials, ensuring patient safety and high-quality execution aligned with applicable laws, Good Clinical Practices (GCP), and sponsor standards.

## What the Work Looks Like

You'll manage investigator site relationships from site activation through database lock, working closely with the Site Care Partner (SCP) and other study team members. You'll act as the primary point of contact for assigned sites, facilitate information flow between the sponsor, vendors, and study sites, and help keep enrollment on track. Your day-to-day responsibilities include:

- Conducting onsite, remote, and electronic monitoring for site initiation, routine monitoring, and close-out, per the Study Monitoring Plan (SMP) and SOPs

- Partnering with the SCP on investigator site development, coaching, and training to maintain compliance and safeguard patients

- Providing protocol training and answering protocol-related questions from site staff, including discussions around known or anticipated operational and clinical risks

- Attending investigator meetings when required, whether virtual or face-to-face

- Supporting enrollment by responding to site activation and recruitment issues and partnering with the study team on recruitment initiatives

- Monitoring adverse events and serious adverse events, coordinating with Drug Safety as needed, and working to bring SAE reports to resolution

- Submitting required reports and documentation within timelines, including TMF documents, site follow-up letters, protocol deviation reports, patient recruitment updates, clinical supply management, and study metrics

- Identifying and resolving investigator site issues, developing corrective and preventative actions with site personnel

- Resolving data queries, preparing site close-out plans, and conducting close-out activities

- Ensuring appropriate oversight of investigational product at sites, including receipt, handling, accounting, storage, and destruction

- Supporting database release and, when appropriate, taking on unblinded monitor responsibilities

You'll also maintain a strong command of the product, protocol, and therapeutic area, so you can have meaningful scientific discussions with investigators and site teams. Interaction with site healthcare professionals should enhance the sponsor's credibility and scientific leadership. You'll support the study clinician on patient safety and eligibility, drive quality event remediation, serve as a point of contact for audits, and help develop CAPAs when needed. In some cases, you may also mentor Clinical Research Associates.

Reporting to the Director of Clinical Site Operations or Director of Site Management and Monitoring, you'll partner with the SCP, Country Study Operations Manager, and other study team members as required.

## Who We're Looking For

This role calls for at least 3 years of relevant experience in clinical research site monitoring within a CRO or pharmaceutical organization, with a preference for 2 years in Oncology. Global clinical trial experience and prior therapeutic experience in Oncology are preferred.

You should bring:

- Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations

- Demonstrated understanding of global and local regulatory requirements

- Working knowledge of key operational elements like monitoring, data acquisition and cleaning, and reporting

- Understanding of disease areas and technical aspects of clinical studies, including company direction and investigational products

- Familiarity with protocol design and feasibility assessment

- Insight into regional culture and medical practice and how they affect clinical trial delivery

- Ability to work in a matrix team environment, influencing others to deliver successful trials

- Strong verbal and written communication skills

- Ability to evaluate and present complex issues and data to support risk management and mitigation

Fluency in English and in the native language(s) of the country you'll work in is required. A valid driver's license and passport are required, and travel within the area is part of the role.

## Education

A bachelor's degree in life sciences or a professional degree in life sciences such as nursing, pharmacy, or medicine is required.

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, including race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status in the US.

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