Senior Clinical Research Associate - FSP

Parexel•United States-California-Remote, CA

About The Position

The Senior Clinical Research Associate oversees clinical trial monitoring and study conduct at assigned investigator sites, from site activation through database lock. The role ensures trials are conducted in accordance with the Study Monitoring Plan, applicable laws, GCP, client standards, SOPs, project timelines, and quality expectations. The associate serves as the primary contact for assigned sites during study conduct and coordinates with the study team, vendors, investigators, and site personnel. The position is preferably based in the West/Pacific/West Coast or Central US and supports studies requiring oncology and non-oncology experience. The role includes site initiation, routine and closeout monitoring, support for site activation and recruitment, investigator and site-staff training, follow-up on adverse-event reporting, and timely submission of study documentation and metrics. The associate maintains detailed understanding of the product, protocol, and therapeutic area; supports patient safety and eligibility; and contributes to risk management, quality-event remediation, and audit corrective and preventive actions. The position reports to a Director of Clinical Site Operations or a Director of Site Management and Monitoring, partners with study operations colleagues, and may mentor Clinical Research Associates. Significant travel within the assigned area is required, with possible international and weekend travel.

Requirements

At least 3 years of relevant clinical research site-monitoring experience; the posting specifies preferably 2 years in Oncology.
Extensive knowledge of clinical-trial methodologies, ICH/GCP, FDA requirements, and local-country regulations.
Global clinical-trial experience.
Fluency in English and the native language(s) of the country where the candidate will work.
Valid driver's license and passport.
Demonstrated knowledge of clinical research and development processes and ability to gain command of process details.
Knowledge of global and local regulatory requirements and key clinical-research operational elements, including monitoring, data acquisition and cleaning, and reporting.
Knowledge of relevant disease and technical areas, investigational products, company direction, and development plans.
Ability to support sponsor regulatory interactions and inspections.
Knowledge of protocol design and feasibility-assessment processes.
Understanding of how region, country, culture, and medical practice affect clinical-trial delivery.
Ability to work in a matrix team environment, influence and lead through others, and contribute to successful trial delivery.
Ability to evaluate, interpret, and present complex issues and data to support risk management and mitigation.
Effective verbal and written communication skills with internal and external colleagues and associates.
Bachelor's degree in life sciences, or a professional degree in life sciences such as nursing, pharmacy, or medicine, or equivalent.
Willingness to travel 60–80% within the assigned area; some international and weekend travel may be required.

Nice To Haves

Oncology experience, preferably 2 years.
Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
Experience with both oncology and non-oncology studies.

Responsibilities

Ensure clinical trials follow the Study Monitoring Plan, applicable laws, GCP, and client standards to meet project goals, timelines, and quality expectations.
Manage assigned operational activities at investigator sites from site activation through database lock.
Serve as the primary point of contact for assigned investigator sites and coordinate with or escalate issues to the SCP as appropriate.
Facilitate information flow among study-team members, vendors, and investigator sites.
Partner with the SCP on investigator-site development, coaching, and training to support protocol compliance and patient safety.
Provide protocol training and address protocol-related questions from site staff, including discussion of operational and clinical trial risks.
Attend investigator meetings when required and support enrollment, site activation, and recruitment initiatives.
Conduct onsite and remote/electronic site initiation, routine, and closeout monitoring in accordance with the SMP and SOPs and in response to emerging issues and technologies.
Monitor site-level adverse events and serious adverse events, collaborate with the Drug Safety Unit, and follow up with sites to resolve required SAE report information.
Submit required reports, documentation, updates, and tracking within required timeframes, including TMF documentation, site reports and follow-up letters, protocol deviations, recruitment, clinical supply management, study progress, and metrics.
Maintain a thorough understanding of the product, protocol, and therapy area and interact with site healthcare professionals to support scientific leadership and clinical-development goals.
Support the study clinician in patient safety, eligibility, and clinical guidance to investigators.
Drive Quality Event remediation when applicable.
Serve as a point of contact for audit conduct and drive audit-observation CAPA development and checks when applicable.
Partner with the SCP and Country Study Operations Manager, and collaborate with other study-team members when required.
May mentor Clinical Research Associates.
Complete required training, timesheets, expense reports, and CV updates, and comply with Parexel processes, ICH-GCP, and other applicable requirements.