Senior Clinical Research Associate

ABOUT MEDICINES360

At Medicines360, we are more than a women’s health innovation organization — we are a catalyst for change. We are fearless in our pursuit of creative approaches to solving consequential women’s health issues and transforming novel ideas into life-changing products that improve the lives of all women, and especially the underserved. We are fiercely dedicated to our mission of improving women’s health worldwide. Our launched products address pressing health concerns of women, providing them with the products they need to live healthier, more fulfilled lives. For more information on Medicines360, please visit Medicines360.org

Position Title: Senior Clinical Research Associate

Reports To: Director, Clinical Operations

FLSA Status: Full-time, Exempt

Location: San Francisco - Hybrid

POSITION SUMMARY:

The Senior Clinical Research Associate (Sr. CRA) is a senior individual contributor responsible for the 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 Sr. CRA supports development programs involving drugs, medical devices, in vitro diagnostic (IVD) devices, and combination products and helps ensure that studies are conducted in accordance with the protocol, applicable regulations, Good Clinical Practice, company procedures, and approved plans. The role combines in-house study management and monitoring visits to investigational sites.

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

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Study Leadership & Site Management

• Lead day to day clinical operations activities across the study lifecycle, including site feasibility, start-up, conduct, monitoring, closeout, and archival, for small through large clinical trials and studies.
• 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 point of contact for investigators and site staff; build strong site relationships and drive site activation, enrollment, and retention against study targets.
• Coordinate site clinical trial agreement and site budget execution and track site payments against agreed terms.

Monitoring

• Plan, conduct, document, and follow up on site qualification, initiation, interim monitoring, remote monitoring, and closeout visits using risk-based and study-specific approaches.
• Where monitoring is outsourced, co-monitor with CRO CRAs, and verify that findings and action items are resolved.
• 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.

CRO & Vendor Coordination

• Serve as the day-to-day operational contact for CROs, central laboratories, imaging or diagnostic vendors, technology providers, depots, and other service providers; track deliverables, quality, timelines, and actions against study plans; escalate performance, scope, or budget concerns to the Director, Clinical Operations.
• Support domestic and international studies by coordinating country- and site-level requirements, local practices, ethics and regulatory submissions, translations, import/export needs, and global study logistics in partnership 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 to the Director, Clinical Operations.

Study Documents & Systems

• 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.
• Maintain oversight of the trial master file and investigator site files, including quality reviews, reconciliation, essential document collection, and inspection-readiness activities.
• Coordinate and track investigational medicinal product, device, IVD kit, 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.

Data Quality, Reporting & Compliance

• Partner with Data Management, Biostatistics, Medical/Safety, Regulatory Affairs, Quality Assurance, Product Development, Manufacturing/Supply, and other functions 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 to support interim analyses and database lock, and communicate emerging risks.
• Maintain study trackers and prepare regular status reports and enrollment and monitoring dashboards for the Director, Clinical Operations to support program and leadership reporting.
• Provide site-level documentation, data, and study status information to support regulatory submissions and reports, including responses to authorities, 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; may coordinate delegated work without direct people-management responsibility.
• Perform other duties and responsibilities consistent with the position and business needs.

ESSENTIAL SKILLS & QUALIFICATIONS:

• Bachelor’s degree in life sciences, nursing, pharmacy, medicine, biomedical engineering, public health, or a related discipline; an advanced degree or equivalent combination of education and relevant experience is preferred.
• Typically 5 or more years of progressively responsible clinical research experience in the biotechnology, pharmaceutical, medical device, diagnostics, CRO, or related industry, including at least 3 years of independent site monitoring and site management experience, experience as a lead CRA or study lead is strongly preferred. Experience in women’s health is highly desirable.
• Demonstrated experience supporting or managing clinical studies of varied size and complexity, including multicenter studies; international study experience is strongly preferred.
• Experience with one or more of the following product types is required: drugs, medical devices, IVD devices, or combination products. Experience spanning multiple product types is preferred.

• Strong working knowledge of Good Clinical Practice and applicable clinical research requirements, including FDA regulations and ICH guidance; ability to identify and apply additional country, regional, ethics, device, IVD, privacy, and product-specific 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.
• Proven ability to co-ordinate day to day with CROs and vendors, manage competing priorities, interpret study metrics, anticipate risks, and drive issues to timely resolution with appropriate escalation.
• Excellent monitoring, documentation, analytical, organizational, problem-solving, and project-management skills, with consistent attention to detail and data integrity.
• Clear, concise written and verbal communication skills and the ability to collaborate and influence across functions, cultures, time zones, and external organizations.
• Ability to work independently in a small, mission-driven organization while contributing flexibly and constructively to a cross-functional team.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams, and the ability to learn and effectively 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.
• Clinical research certification (e.g., ACRP CCRA or ACRP-CP, or SOCRA CCRP) is a plus.

IN OFFICE PRESENCE: Tuesday, Wednesday & Thursday

PHYSICAL DEMANDS/MISC:

• Must be able to remain in a stationary position 50% of the time.
• The person in this position may need to occasionally move throughout the office to attend meetings in different rooms.
• Continuously operates a computer and occasionally uses other office productivity machinery, such as copy machines, and computer printer.
• The ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in these situations.
• The ability to observe details at close range (within a few feet of the observer).

Medicines360 is committed to a diverse workplace and to equal opportunity employment for all job applicants, regardless of race, color, religion, sex, sexual orientation, age, gender identity or expression, national origin, disability, or veteran status. Medicines360 complies with all applicable local, state, and national laws governing nondiscrimination in employment.