Clinical Research Associate

Science; Alameda, Northern (CA, KY); Hybrid; USD 120.000 - 145.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Equity

Medical, dental, vision

Flexible vacation & holidays

Company-paid meals (onsite)

Zusammenfassung

Science is seeking a Clinical Research Associate (CRA) to lead start-up, monitoring, and close-out of US trials, ensuring subject safety and data integrity. The role serves as the main liaison with trial sites, ensuring adherence to protocol, FDA regulations, ISO 14155, and internal SOPs while identifying process improvements.

Travel up to 40% across the United States and occasional abroad is expected. Strong technical writing and CTMS/EDC proficiency are required to succeed.

Qualifikationen

• Bachelor’s degree in Life Sciences, Nursing or related field.
• 2+ years of direct field monitoring experience in medical devices.
• Familiarity with FDA 21 CFR Part 812 and GCP.
• Proficiency with CTMS, EDC and eTMF platforms.
• Strong technical writing skills for monitoring reports.
• Willingness to travel up to 40% across the US and occasionally abroad.

Aufgaben

• Organize study start-up and close-out materials for US trials.
• Conduct full cycle of site visits (Pre-study, Initiation, Routine, Close-out).
• Review source documents for accuracy in CRFs and EDC.
• Track inventory of investigational devices at sites.
• Identify and report Adverse Events per FDA/IRB timelines.
• Audit regulatory documents and maintain TMF.
• Educate site staff on device tech and protocol nuances.
• Coordinate IRB submissions with Sponsor and sites.
• Maintain study/status databases for internal reporting.

Kenntnisse

Field monitoring

Technical writing

Remote work capable

Process improvement mindset

Ownership mindset

Clinical trial monitoring

GCP familiarity

Ausbildung

Bachelor’s degree in Life Sciences or Nursing

Tools

CTMS

EDC

eTMF

Jobbeschreibung

Science is a clinical stage, vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost it. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

We are seeking a Clinical Research Associate (CRA) that will responsible for the clinical study start-up, monitoring, and close-out of US-based trials to ensure the safety of human subjects and the integrity of clinical data. This role serves as the primary point of contact between the company and the clinical study sites (hospitals and clinics). This CRA will verify that all trial activities are conducted in strict accordance with the study protocol, FDA regulations, ISO 14155 standards, and internal standard operating procedures. The ideal candidate is a go-getter who steps in wherever the study needs support. The CRA is expected to spot inefficiencies before they become bottlenecks, propose process improvements without being asked, and bring an ownership mentality to study success rather than just task completion.

Key Responsibilities

• Organize study start-up and close out materials for US-based clinical studies.
• Conduct the full cycle of site visits, including Pre-study Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits.
• Perform rigorous review of source documents to ensure data reported on paper case report forms and/or in the Electronic Data Capture (EDC) system is accurate, complete, and verifiable.
• Track and manage the inventory of investigational medical devices at each site, ensuring proper storage, use, and return/disposal.
• Ensure that all Adverse Events and Serious Adverse Events are identified, documented, and reported within the required FDA and IRB timelines.
• Audit regulatory documentation and maintain Sponsor trial master file (TMF) to ensure all essential documents are current and compliant.
• Educate site staff on the specific nuances of the medical device technology and the requirements of the clinical protocol.
• Coordinate IRB submissions with Sponsor staff and study sites.
• Maintain study and site status databases for internal reporting on study progress.

Key Qualifications

• Bachelor’s degree in Life Sciences, Nursing (RN), or a related healthcare field.
• 2+ years of direct field monitoring experience, specifically within the medical device industry.
• Familiarity with US FDA 21 CFR Part 812 (Investigational Device Exemptions) and GCP (Good Clinical Practice).
• Proficiency in Clinical Trial Management Systems (CTMS), EDC, and eTMF platforms.
• Strong technical writing skills for the production of clear, concise, and compliant monitoring reports.
• Ability to travel 40% of the time across the United States and occasionally abroad to coordinate with other clinical teams.
• Proven ability to work remotely and manage a complex schedule of site visits and administrative follow-ups.
• A bias toward action - you'd rather propose a fix and iterate than wait for permission
• Genuine curiosity about how clinical trials could work better, not just how they currently do
• Comfort operating outside a narrow lane when the study needs it
• A track record (or strong instinct) for identifying and driving process improvements, not just following them

Preferred Qualifications

• CCRA (ACRP) or CCRP (SoCRA) certification.
• Experience monitoring Class II or Class III (PMA) medical device trials.
• Experience with surgical or operating room (OR) monitoring environments.

Salary/Pay Range:

Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $120,000 - $145,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

Benefits:

• Competitive salary and equity.
• Medical, dental, vision, and life insurance.
• Flexible vacation and company-paid holidays.
• Healthy meals and snacks provided for non-remote employees.
• Paid parental, jury duty, bereavement, family care, and medical leave.
• Dependent Care Flexible Spending Account, subsidized by Science.
• Flexible Spending Account.
• 401(k).

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state and local laws.