Associate, Maplegrove, MN

Role Summary

The Field Clinical Research Associate (Field CRA) is responsible for monitoring clinical research sites to ensure compliance with study protocols, ICH-Google Cloud Platform requirements, applicable regulatory requirements, and sponsor procedures. The Field CRA serves as the primary monitoring resource for assigned sites, conducting routine site visits, reviewing study documentation, identifying risks and compliance concerns, and driving timely resolution of findings and action items throughout the clinical study lifecycle.

Key Responsibilities

•       Conducts site qualification, initiation, interim monitoring, and closeout visits according to study monitoring plans.

•       Assesses site compliance with study protocols, ICH-Google Cloud Platform requirements, sponsor procedures, and applicable regulations.

•       Reviews study conduct and documentation to ensure participant safety and data integrity.

•       Evaluates site performance and identifies risks that may impact study quality, compliance, enrollment, or timelines.

•       Identifies protocol deviations, documentation deficiencies, data quality issues, and compliance concerns during monitoring activities.

•       Communicates findings and observations to site personnel in a timely manner; documents findings and required corrective actions.

•       Tracks site action items through completion and verifies effectiveness of corrective and preventive actions (CAPA).

•       Escalates significant compliance issues and quality concerns per established procedures.

•       Reviews source documentation for accuracy, completeness, and consistency with clinical database records via SDV and SDR activities.

•       Facilitates resolution of data queries with site personnel; identifies missing, inconsistent, or inaccurate data and ensures correction.

•       Reviews adverse event documentation, protocol deviations, and endpoint documentation for completeness and accuracy.

•       Verifies regulatory documentation is current, accurate, complete, and inspection-ready.

•       Reviews informed consent documentation for compliance with protocol and regulatory requirements.

•       Prepares complete, accurate, and timely monitoring visit reports; maintains monitoring records in accordance with sponsor requirements.

•       Utilizes study metrics and performance indicators to assess site risk and support risk-based monitoring strategies.

Required Qualifications

•       Associate’s degree or equivalent combination of education and experience.

•       Minimum 4 years of clinical research experience.

•       Knowledge of ICH-Google Cloud Platform guidelines and applicable regulatory requirements.

•       Experience conducting monitoring visits and site oversight activities.

•       Strong understanding of clinical trial documentation requirements and data quality processes.

•       Excellent written and verbal communication skills.

•       Ability to independently manage multiple sites and priorities.

•       Proficiency with electronic data capture (EDC), CTMS, and trial master file (TMF) systems.

•       Ability to travel up to 50-75%.

Preferred Qualifications

•       Bachelor’s degree in Nursing, Life Sciences, Health Sciences, Engineering, or related discipline.

•       Prior experience as a CRA, Site Monitor, or Field Clinical Monitor.

•       Experience supporting cardiovascular, structural heart, rhythm management, electrophysiology, vascular, or heart failure clinical trials.

•       Experience with risk-based monitoring methodologies.

•       Knowledge of FDA regulations and global clinical research requirements.

•       Experience supporting audits and regulatory inspections.