Clinical Research Monitor(CRA)

PSG Global Solutions; Minneapolis (MN); On-site; USD 70,000 - 100,000; Full time

Job summary

A leading company in the Healthcare Systems and Services industry is seeking a Clinical Research Monitor (CRA) based in Minneapolis. This role involves overseeing clinical trials, ensuring regulatory compliance, and fostering relationships with key stakeholders. Ideal candidates will have a strong background in clinical monitoring and data analysis, along with excellent interpersonal skills.

Qualifications

• Experience in clinical trial monitoring and adherence to GCP and regulatory requirements.
• Ability to develop and maintain relationships with investigators and institutions.

Responsibilities

• Monitor clinical trials for protocol adherence and compliance.
• Train site personnel and facilitate study initiation.
• Analyze performance metrics and oversee risk indicators.

Skills

Clinical Monitoring

Regulatory Compliance

Data Analysis

Relationship Management

Risk Management

Job description

Description

We're looking for a Clinical Research Monitor (CRA) in the Healthcare Systems and Services industry, based in Minneapolis, Minnesota, United States.

Job Description:

1. Monitor the progress of clinical trials at the site or headquarters level, ensuring adherence to the protocol, SOPs, GCP, and regulatory requirements.
2. Develop and maintain relationships with clinical investigators, CROs, hospitals, and research institutions to initiate and facilitate clinical studies involving investigational drugs or medical devices.
3. Review adverse event cases with investigators, monitor timelines, budgets, schedules, and prepare study documentation and status reports.
4. Assist with the design, development, and monitoring of clinical evaluation projects.
5. Train investigators and site personnel.
6. Coordinate activities between headquarters and field CRAs.
7. Implement and contribute to clinical development strategies outlined by clinical teams.
8. Identify and recommend qualified investigators for conducting studies and initiating trials.
9. Ensure patient recruitment and retention.
10. Plan, execute, and validate centralized Risk-Based Monitoring processes in compliance with regulations and policies.
11. Conduct centralized monitoring across all trial phases using platforms like OC-RDC and CTMS.
12. Contribute to monitoring plans, guidelines, and data verification plans.
13. Analyze site performance metrics and trends.
14. Oversee operational risk indicators, investigating and mitigating trial risks.