Sr. Clinical Research Associate

Digital Prospectors; Redwood City (CA); Sur place; USD 83 000 - 152 000; Plein temps

Résumé du poste

Digital Prospectors seeks a Senior Clinical Research Associate to lead monitoring across in vitro diagnostic studies, including RUO/IUO/CDx programs, and ensure regulatory compliance. This onsite role manages timelines, mentors junior staff, and partners with cross-functional teams to deliver high-quality studies.

You will oversee monitoring plans, study documents, and data transfers, while driving process improvements. Travel up to 10–20% is required; based in Redwood City, CA.

Qualifications

• Bachelor’s degree in life sciences, health sciences, or related discipline and approximately five years of relevant clinical research or clinical-operations experience; or a master’s degree in a related discipline and approximately three years of relevant experience.
• Thorough knowledge of Good Clinical Practice, ICH guidelines, clinical-trial regulations, monitoring practices, data integrity, and essential clinical-study documentation.
• Experience leading study plans, timelines, monitoring activities, and cross-functional coordination with minimal day-to-day supervision.

Responsabilités

• Lead monitoring activities for assigned studies, including site initiation, interim monitoring, and close-out visits, to ensure site compliance with study protocols and applicable regulatory requirements.
• Set priorities and ensure monitoring plans are executed effectively.
• Independently generate project plans, particularly those related to laboratory management, site management, monitoring, and reporting.
• Oversee TMF quality, completeness, and inspection readiness through active management of essential study documents.
• Lead cross-functional study meetings and collaborate with Bioinformatics, Regulatory, Software, Quality, Reporting, and other functions to evaluate needs, resources, and timelines.
• Mentor junior monitors and contribute to training materials and best-practice development.
• Maintain a strong technical understanding of relevant assay and/or instrument principles and clinical-trial systems used to support assigned studies.
• Execute and deliver data transfers in accordance with outlined specifications, including DTA/DTS requirements.
• Proactively identify and participate in process-improvement initiatives as needed.
• Serve as the primary operational point of contact for pharmaceutical partners.

Connaissances

Site monitoring experience

Project management

Mentoring

Communication

Regulatory knowledge

Formation

Bachelor’s degree in life sciences, health sciences, or related discipline

Master’s degree in related discipline

Outils

Clinical-trial software

Electronic TMF systems

Data-transfer tools

Description du poste

Position: Sr. Clinical Research Associate

Location: Redwood City, CA (Onsite)

Length: 6+ Month Contract

Job Description:

The Senior Clinical Research Associate independently leads clinical-study monitoring and site-management activities across in vitro diagnostic (IVD) studies, including research use only (RUO), investigational use only (IUO), and companion diagnostic (CDx) programs, as applicable. This role leads monitoring activities, manages project timelines and deliverables, resolves study issues, mentors junior colleagues, and partners with cross-functional teams to deliver high-quality, compliant studies.

Essential Duties and Responsibilities:

• Lead monitoring activities for assigned studies, including site initiation, interim monitoring, and close-out visits, to ensure site compliance with study protocols and applicable regulatory requirements.
• Set priorities and ensure monitoring plans are executed effectively.
• Independently generate project plans, particularly those related to laboratory management, site management, monitoring, and reporting.
• Oversee TMF quality, completeness, and inspection readiness through active management of essential study documents.
• Lead cross-functional study meetings and collaborate with Bioinformatics, Regulatory, Software, Quality, Reporting, and other functions to evaluate needs, resources, and timelines.
• Mentor junior monitors and contribute to training materials and best-practice development.
• Maintain a strong technical understanding of relevant assay and/or instrument principles and clinical-trial systems used to support assigned studies.
• Execute and deliver data transfers in accordance with outlined specifications, including DTA/DTS requirements.
• Proactively identify and participate in process-improvement initiatives as needed.
• Serve as the primary operational point of contact for pharmaceutical partners.

Qualifications:

• Bachelor’s degree in life sciences, health sciences, or a related discipline and approximately five years of relevant clinical research or clinical-operations experience; or a master’s degree in a related discipline and approximately three years of relevant experience.
• Demonstrated advanced site-monitoring experience, including independent management of study start-up, routine monitoring, and close-out activities.
• Thorough knowledge of Good Clinical Practice, ICH guidelines, clinical-trial regulations, monitoring practices, data integrity, and essential clinical-study documentation.
• Experience leading study plans, timelines, monitoring activities, and cross-functional coordination with minimal day-to-day supervision.
• Strong problem-solving, project-management, mentoring, written communication, verbal communication, and relationship-building skills.
• Experience with clinical-trial software, electronic TMF systems, and data-transfer or study-reporting tools.
• Willingness to travel up to 10–20% as needed.

Preferred Qualifications

• Experience supporting RUO, IUO, and/or CDx studies, as applicable to the business.
• Experience in oncology, in vitro diagnostic device trials, clinical laboratory assay or instrument studies, or precision medicine.
• Experience with investigator meetings, pharmaceutical partner support, and vendor management.
• Relevant professional certification, such as CCRA or CCRP.

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.