Clinical Research Associate Ii

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

The In-House Clinical Research Associate II will oversee clinical trial activities at investigational sites, conduct and write accurate visit reports in accordance with GCP and monitoring plans, including pre-study, site initiation, routine monitoring, and close-out visits.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Responsible for ensuring that study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies by training/guidance of investigators/research coordinators, conducting periodic on-site evaluations and follow-up of corrective actions.
• Acts as primary liaison to clinical sites.
• Conducts remote (if applicable) and in-person site qualification visits, study start-up activities (essential document collection), site initiation visits and training, monitoring visits for source data verification (reported study data are accurate, complete, and verifiable from source documents in the site’s medical records), and site close-out visits. Generates high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner (in accordance with the Clinical Monitoring Plan).
• Contributes to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion to report the study results to FDA and other regulatory authorities.
• Ensures that the rights and well-being of human subjects are protected, ensuring informed consent procedures and protocol are followed in accordance with GCP and applicable regulations, confirms data quality/integrity by maintaining site compliance, reviewing adverse events and device deficiencies, reviewing data trending/metrics, reviewing audit reports, and implementing corrective actions as necessary.
• Supports maintenance of department SOPs and work instructions.
• Supports investigational device traceability including documentation for forecasting, shipping, receipt, and disposition, as applicable.
• Supports and maintains documentation of all Clinical Research activities in the study trial master file (TMF), e.g., monitoring reports, site correspondence, device inventory information.
• Drives trial enrollment, identifies and communicates potential and actual obstacles to enrollment.
• Conducts Clinical Operations duties as assigned (ie. CRF reviews/data QC, run and review study data reports, site management, obtain and track follow up study visits).

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must have working knowledge of Good Clinical Practices (GCPs), FDA regulations and IRB requirements.
• Must have strong project management competencies and ability to work with high quality, reliability, and attention to detail.
• Must have a strong level of professionalism, including verbal and written communication skills; and the ability to communicate with all levels of the organization, cross-functionally, and with clients/partners.

Qualifications

• Minimum 5 years of directly related work experience or equivalent in Clinical Research, including work on medical device trials.
• SOCRA/ACRP Certification
• BS or BA degree preferred; science or related field also preferred.
• Travel requirement: 50%

Additional Information

Your information will be kept confidential according to EEO guidelines.

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