**Please note** Treace Medical Concepts, Inc. has recently become aware of fake “Treace” job offers being made by scammers. Treace Medical will make an offer of employment only to individuals who have applied for a position using our official application. Be on alert for possible fraudulent offers of employment. Treace Medical will never solicit money or banking information from applicants.

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.

The Sr. Clinical Research Associate 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.

What you will be doing in the role:

• 
  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 and in-person site qualification visits, study start-up activities (essential document collection), site qualification visits, 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 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 and 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 investigational device traceability including documentation for forecasting, shipping, receipt, and disposition.
• 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.

• Five (5) years of directly related work experience or equivalent in clinical research, including work on medical device trials.
• HS Diploma Required, BS or BA degree preferred; science or related field also preferred.
• Must be able to travel 50% of the time

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace is a drug free employer.