Sr. Clinical Research Associate (Field)

ShifaMed•Los Gatos, CA

60d•$120,000 - $140,000•Remote

About The Position

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. ABOUT SHIFAMED 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 a field-based Senior Clinical Research Associate (Senior CRA) who will play a critical role in overseeing and managing clinical trial 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. This is a full time, remote position with anticipated travel of up to 80%. Preferred geographic locations: NJ, NY, PA, OH, MI, AZ, or CA

Requirements

Bachelor's degree in life sciences, nursing, biomedical engineering, or related discipline.
Minimum 5-7 years of experience in clinical research, including at least 3 years of independent monitoring for medical device trials. Experience in IDE 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.

Nice To Haves

Prior experience in cardiovascular or interventional device studies strongly preferred.

Responsibilities

Serve as the primary point of contact for investigative sites, fostering strong and collaborative site relationships.
Monitoring 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.
Monitor clinical data to ensure accuracy, completeness, and integrity in alignment with EDC systems and clinical data management standards.
Oversee patient recruitment, enrollment progress, and data integrity across pivotal study sites.
Providing 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.