Sr. Clinical Research Associate (Field)
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AI Summary
The Senior CRA is responsible for monitoring clinical trial sites to ensure adherence to protocols, regulatory requirements, and GCP standards. This includes conducting site visits, reviewing clinical data for integrity, and managing site relationships to ensure successful trial execution.
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
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 one 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 lifecycle. These are full time, remote positions with anticipated travel of up to 80%.
Preferred geographic locations: GA, NC, SC, TN, or VA
- Southeast (1): GA, NC, SC, TN, or VA
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:
- 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 hr@shifamed.com.
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 hr@shifamed.com.
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