Sr. Clinical Research Associate (Field)

Shifamed; Los Gatos (CA); Remote; USD 120,000 - 140,000; Full time

Benefits offered by this job

Equity

Benefits

Job summary

A leading medical device company is hiring a Senior Clinical Research Associate (Field) in the Los Gatos area. This full-time remote role involves monitoring clinical trial sites and ensuring compliance with regulations. Applicants should have a Bachelor's degree in life sciences and at least 5 years of experience in clinical research, particularly with medical devices. The position offers a salary range of $120,000 - $140,000, equity, and benefits along with travel up to 80%.

Qualifications

• 5+ years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials.
• Prior experience in cardiovascular or interventional device studies strongly preferred.
• Strong working knowledge of GCP, ISO 14155 and FDA guidelines.

Responsibilities

• Serve as the primary point of contact for investigative sites.
• Monitor patient data and clinical trial sites for adherence to study protocols.
• Lead and conduct on-site and remote monitoring visits.
• Critically review clinical data for accuracy and integrity.
• Engage site staff in development of enrollment targets.
• Provide training and guidance to site staff and other CRAs.

Skills

Clinical research

Monitoring

Data integrity

Regulatory compliance

Excellent communication skills

Stakeholder management

Education

Bachelor’s degree in life sciences or related discipline

Tools

EDC

eTMF

Microsoft Office

Job description

Position: Sr. Clinical Research Associate (Field)

Location: Los Gatos, CA

Job Id: 626

# of Openings: 2

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low‑profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com.

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.

Description

We are seeking two field‑based Senior Clinical Research Associates (Senior CRA's) who will play a critical role in monitoring and managing clinical trial site activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle. These are full‑time, remote positions with anticipated travel of up to 80%.

Preferred Geographic Locations

• Southeast (1): GA, NC, SC, TN, or VA
• West (1): AZ or CA

Responsibilities, Skills & Hands‑On Experience

• Serve as the primary point of contact for investigative sites, fostering strong and collaborative site relationships.
• Monitor patient data and clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Lead and conduct on‑site and remote monitoring visits (site qualification, initiation, monitoring, and close‑out) to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Critically review clinical data to ensure accuracy, completeness, and integrity in alignment with EDC systems and clinical data management standards.
• Engage site staff in development of enrollment targets, track enrollment progress, and troubleshoot patient recruitment issues.
• Provide training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Maintain oversight of investigational product accountability, tracking, and reconciliation for cardiovascular devices.
• Partner closely with internal stakeholders to align clinical activities with business and regulatory objectives.
• Identify, document, and assist in resolving protocol deviations and CAPAs.
• Participate in internal audits and support readiness for regulatory inspections.

Education & Work Experience

• Bachelor’s degree in life sciences, nursing, biomedical engineering, or related discipline.
• 5+ years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials. Experience in IDE studies strongly preferred.
• Prior experience in cardiovascular or interventional device studies strongly preferred.
• Strong working knowledge of GCP, ISO 14155 and FDA guidelines.
• Proficient in EDC, eTMF, and Microsoft Office tools.
• Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.

Our salary ranges are calculated by role, level, and location. Please note that your position within that range will be determined by your job‑related knowledge, location, skills, experience, relevant education, and training/certifications. The base salary range for this full‑time position is between $120,000 - $140,000 + equity + benefits.

NOTICE TO CANDIDATES

Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to [e-mail].