Full-Time Clinical Research Associate II

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 study investigators and coordinators comply with study protocol, GCPs, CFRs, and IRB/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, CRF and study plan development as well as APRs and CSR at study conclusion to report 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.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must have working knowledge of 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 EDC and 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%

WORK ENVIRONMENT:

This job operates in a professional office environment. This role routinely uses standard office equipment.

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