Job Description

** POSITION SUMMARY:**

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 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 maintenance of department SOPs and work instructions.
• 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.
• Drives trial enrollment and identifies and communications potential and actual obstacles to enrollment.

Qualifications

** 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.
• Must have proficiency in using Microsoft Office Suite, including Word, Excel, Outlook and PowerPoint; as well as experience with electronic data capture (EDC) and electronic Trial Master File (eTMF) systems.
• Experience interfacing successfully with physicians/clinical staff and familiarity with hospital/clinical environments.
• Familiarity with medical and anatomical terminology.
• Ability and willingness to travel.

** EDUCATION & EXPERIENCE REQUIREMENTS:**

• A minimum of 5 years of directly related work experience or equivalent in clinical research, including work on medical device trials and orthopedics.
• SUCRA/ACRP Certification, preferred
• BS or BA degree preferred; science or related field also preferred.
• Travel requirement: 50%

Additional Information

All your information will be kept confidential according to EEO guidelines.

** WORK ENVIRONMENT:** ** __**

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. This position may require prolonged periods of sitting and working on a computer or standing as well as the ability to bend and lift up to 20 lbs.

This job description is not a contract and does not affect the at-will nature of your employment relationship with Treace Medical Concepts, Inc., Furthermore, this job description is not intended to be all-inclusive and does not and cannot address every responsibility or duty you may be expected to perform during your employment. Treace Medical Concepts, Inc., reserves the right to modify or amend this job description at its discretion, without prior notice.

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