Sr. Clinical Research Associate (Field)

Los Gatos, CA - USA

Monthly Salary: $ 120000 - 140000

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

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 .

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 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 is a full time remote position with anticipated travel of up to 80%.

Preferred geographic locations: NJ NY PA OH MI 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 tracking enrollment progress and troubleshooting 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:

Bachelors degree in life sciences nursing biomedical engineering or related discipline.
Minimum 57 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 $120000 - $140000 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

Required Experience:

Senior IC

Description:

Preferred geographic locations: NJ NY PA OH MI 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 tracking enrollment progress and troubleshooting 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:

Bachelors degree in life sciences nursing biomedical engineering or related discipline.
Minimum 57 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.