Senior Clinical Research Associate

Medicines360 • San Francisco, CA

1d • $116,000 - $125,000 • Hybrid

About The Position

The Senior Clinical Research Associate (Sr. CRA) is a senior individual contributor responsible for day-to-day operational execution, site management, and monitoring of domestic and international clinical trials and other clinical studies, ranging from small focused studies to large, complex multicenter programs. The role supports development programs involving drugs, medical devices, in vitro diagnostic (IVD) devices, and combination products, helping ensure studies comply with protocols, applicable regulations, Good Clinical Practice, company procedures, and approved plans. The position combines in-house study management with monitoring visits to investigational sites.

Working cross-functionally and with CROs, vendors, investigators, and study sites, the Sr. CRA leads assigned studies or substantial workstreams and serves as the primary day-to-day contact for sites and CRO study teams. The role drafts and maintains key study documents, identifies and resolves operational risks, and maintains inspection-ready documentation and high-quality clinical data. It may also provide technical guidance, coaching, and mentorship to junior clinical staff. The role reports to the Director, Clinical Operations.

The position is full-time, exempt, and hybrid in San Francisco. In-office presence is Tuesday, Wednesday, and Thursday. Domestic and international travel may be required up to approximately 50%, with periods of higher travel depending on study needs, site distribution, and program phase.

Requirements

• Bachelor’s degree in life sciences, nursing, pharmacy, medicine, biomedical engineering, public health, or a related discipline.
• Typically at least 5 years of progressively responsible clinical research experience in biotechnology, pharmaceuticals, medical devices, diagnostics, CROs, or a related industry, including at least 3 years of independent site monitoring and site management experience.
• Experience supporting or managing clinical studies of varied size and complexity, including multicenter studies.
• Experience with at least one of the following product types: drugs, medical devices, IVD devices, or combination products.
• Strong working knowledge of Good Clinical Practice and applicable clinical research requirements, including FDA regulations and ICH guidance, and ability to apply additional requirements in collaboration with internal experts.
• Working knowledge of clinical quality systems, essential document requirements, electronic trial master files, electronic data capture, clinical trial management systems, safety systems, and other study technologies.
• Ability to coordinate day-to-day with CROs and vendors, manage competing priorities, interpret study metrics, anticipate risks, and drive issues to timely resolution with appropriate escalation.
• Strong monitoring, documentation, analytical, organizational, problem-solving, and project-management skills, with attention to detail and data integrity.
• Clear written and verbal communication skills and ability to collaborate and influence across functions, cultures, time zones, and external organizations.
• Ability to work independently in a small, mission-driven organization and contribute flexibly to a cross-functional team.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams, and ability to learn and use clinical systems and emerging technologies.
• Ability to travel domestically and internationally up to approximately 50%, with periods of higher travel based on study needs, site distribution, and program phase.

Nice To Haves

• Advanced degree or equivalent combination of education and relevant experience.
• Experience as a lead CRA or study lead.
• Experience in women’s health.
• International study experience.
• Experience spanning multiple product types, including drugs, medical devices, IVD devices, or combination products.
• Clinical research certification, such as ACRP CCRA, ACRP-CP, or SOCRA CCRP.

Responsibilities

• Lead day-to-day clinical operations across the study lifecycle, including feasibility, start-up, conduct, monitoring, closeout, and archival.
• Independently manage assigned studies, sub-studies, countries, regions, sites, or functional workstreams, escalating material risks and decisions to the Director, Clinical Operations.
• Serve as the primary contact for investigators and site staff; build site relationships and support site activation, enrollment, and retention against targets.
• Coordinate site clinical trial agreements and budgets, and track site payments against agreed terms.
• Plan, conduct, document, and follow up on site qualification, initiation, interim monitoring, remote monitoring, and closeout visits using risk-based and study-specific approaches.
• Co-monitor with CRO CRAs when monitoring is outsourced, and verify resolution of findings and action items.
• Assess site performance, protocol compliance, informed consent, participant safety, source documentation, investigational product or device accountability, data quality, and regulatory file completeness; ensure timely corrective and preventive follow-up.
• Coordinate day-to-day operations with CROs and vendors, tracking deliverables, quality, timelines, and actions against study plans and escalating performance, scope, or budget concerns.
• Coordinate country- and site-level requirements, local practices, ethics and regulatory submissions, translations, import/export needs, and global study logistics with relevant subject-matter experts.
• Provide operational and site-level input to feasibility, site selection, enrollment projections, timelines, and risk assessments; maintain study risk and issue logs and propose mitigations.
• Draft, review, and maintain clinical documents, including informed consent form templates, case report forms, monitoring plans, study manuals, training materials, visit reports, newsletters, plans, and clinical study report content.
• Oversee the trial master file and investigator site files, including quality reviews, reconciliation, essential document collection, and inspection-readiness activities.
• Coordinate and track investigational medicinal products, devices, IVD kits, specimen collection materials, ancillary supplies, and combination-product components, including shipment, storage, accountability, calibration or maintenance, resupply, return, destruction, and expiry as applicable.
• Support study-specific training for investigators, site personnel, monitors, CRO teams, and vendors; present at investigator meetings and internal study meetings.
• Partner with cross-functional groups to resolve protocol, safety, data, product, and operational issues.
• Review enrollment and retention, monitoring metrics, data listings, queries, deviations, safety information, product complaints, device deficiencies, and study trends; drive timely site-query resolution and data cleaning and communicate emerging risks.
• Maintain study trackers and prepare status reports and enrollment and monitoring dashboards for the Director, Clinical Operations.
• Provide site-level documentation, data, and study status information to support regulatory submissions and reports, including authority responses, annual reports, and final reports as applicable.
• Participate in audits and regulatory inspections; prepare sites and vendors, provide requested documentation, support responses and CAPAs, and track commitments to completion.
• Contribute to the development and continuous improvement of clinical SOPs, templates, tools, and operational processes.
• Provide mentoring, co-monitoring, quality review, and day-to-day technical guidance to less experienced CRAs or study team members; coordinate delegated work as needed.
• Perform other duties and responsibilities consistent with the position and business needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior