Sr. Clinical Research Associate (Field)

Supira Medical, Inc.; Georgia; Sur place; USD 120 000 - 140 000; Plein temps

Résumé du poste

A medical device innovation hub is seeking a Senior Clinical Research Associate to oversee clinical trial site activities. This full-time, remote role involves monitoring trials to ensure compliance and require up to 80% travel. Candidates should have a Bachelor’s degree in life sciences and 5-7 years of clinical research experience, preferably with medical devices. Strong communication and stakeholder management skills are essential.

Qualifications

• 5–7 years of clinical research experience, with 3 years in independent monitoring.
• Strong knowledge of GCP and FDA guidelines.
• Experience in cardiovascular device studies preferred.

Responsabilités

• Monitor patient data and site adherence to protocols.
• Conduct monitoring visits to assess site performance.
• Engage site staff in enrollment target development.

Connaissances

Clinical research experience

Communication skills

Stakeholder management

Knowledge of GCP

EDC and eTMF proficiency

Formation

Bachelor’s degree in life sciences

Outils

Microsoft Office

Description du poste

Sr. Clinical Research Associate (Field)

Shifamed is seeking a field-based Senior Clinical Research Associate to play a critical role in monitoring and managing clinical trial site activities to ensure compliance with protocol, regulatory requirements, and industry standards. The role is full‑time, remote, with anticipated travel up to 80% and preferred geographic locations of NJ, NY, PA, OH, MI, AZ, or CA.

Base pay range

$120,000.00/yr - $140,000.00/yr

About Shifamed

Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on developing novel products to address clinical needs in cardiology and ophthalmology. 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 PCI procedures and in patients with cardiogenic shock. Visit www.supiramedical.com for more information.

Responsibilities

• 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.

Qualifications

• 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.
• 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.

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].

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Research, Analyst, and Information Technology

Industries

Medical Equipment Manufacturing