Job Description

Senior Field Clinical Research Specialist role overseeing clinical trial site management, regulatory compliance, and case coverage across Chicago and Northwest Indiana territory. Requires master's degree in life sciences and two years of clinical research experience with GCP, FDA regulations, and trial management systems.

Responsibilities

• Oversee clinical trial site management, initiation, monitoring, and closeout activities
• Ensure adherence to GCP guidelines, FDA regulations, and ICH-GCP compliance across all study activities
• Develop and revise Clinical Investigation Plans, Informed Consent Forms, protocols, and supporting study materials
• Coordinate IRB/IEC submissions and manage patient recruitment, retention, and adverse event reporting
• Direct site staff and physicians in product use within clinical laboratory settings and implement CAPA as needed

Requirements

• Master's degree in Biological Science, Biology, Nursing, Biomedical Engineering, or Biotechnology
• Two years of clinical research experience with GCP and regulatory compliance for Phase I-IV trials
• Two years of experience in clinical study startup, site initiation, monitoring, and closeout
• Two years of experience with ICF/Protocol development, patient recruitment, SDV, and adverse event reporting
• Two years of FDA 21 CFR regulations and ICH-GCP E6 R2/R3 compliance knowledge
• Two years of experience with CTMS platforms including Veeva Vault, Oracle Siebel, and Salesforce
• Valid driver's license and insurability; ability to travel domestically up to 75% within assigned territory

Compensation: $128,500-$170,400 per year

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