Remote Field Clinical Research Lead, Cardiac Trials

Medtronic; United States; À distance; USD 129 000 - 170 000; Plein temps

Avantages offerts par ce poste

Health insurance

Dental and vision insurance

Health Savings Account

Healthcare Flexible Spending Account

Life insurance

Long-term disability leave

Dependent daycare spending account

Tuition assistance/reimbursement

Well-being program

1 401(k) plan with company match

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Résumé du poste

Medtronic is seeking a Sr. Field Clinical Research Specialist to lead field-based clinical studies in the Minneapolis area with remote work from a Chicago metro home office. You will manage trial start-up, monitoring, and close-out, while ensuring adherence to GCP, FDA regulations, and ICH‑GCP guidelines.

The role requires 2+ years in clinical research and travel up to 75% within the territory. You will use CTMS tools to track data and coordinate IRB submissions, CAPA, and regulatory compliance.

Qualifications

• Master's degree in Biological Sciences, Nursing, Biomedical Engineering, or Biotechnology with 2 years in clinical research.
• 2+ years' experience with GCP/regulatory guidelines for trials (Phase I–IV).
• 2+ years' experience in study start-up, site initiation, monitoring, and close-out.
• 2+ years' experience in protocol/ICF development and amendments.
• 2+ years' experience in patient recruitment, SDV, and AE/SAE reporting.
• 2+ years' experience with FDA 21 CFR Parts 11, 50, 54, 56, 312, 812 and ICH-GCP (E6 R2/R3).
• 2+ years' experience with IRB/IEC submission and approval processes.
• 2+ years' experience with CAPA and HIPAA compliance.
• Experience with CTMS, Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce.

Responsabilités

• Lead field-based clinical studies with site management and case coverage.
• Prepare and revise Clinical Investigation Plans and study materials.
• Train investigators and site staff on protocols and amendments.
• Ensure compliance with GCP and regulatory guidelines throughout trials.
• Coordinate start-up, initiation, monitoring, and close-out activities.
• Drive patient recruitment and retention strategies and SDV.
• Navigate FDA/ICH-GCP regulations and IRB/IEC submissions.
• Implement CAPA and HIPAA compliance measures.
• Utilize CTMS tools (Veeva, Siebel, Salesforce) for data tracking.

Connaissances

GCP compliance

Clinical trial design

Site initiation

Monitoring

SDV

AE/SAE reporting

IRB submission

CAPA

HIPAA

CTMS systems

Formation

Master's degree in Biological Sciences

Outils

CTMS

Veeva Vault CTMS

Oracle Siebel CTMS

Salesforce

Description du poste

Medtronic is seeking a Sr. Field Clinical Research Specialist to lead field-based clinical studies in the Minneapolis area with remote work from a Chicago metro home office. You will manage trial start-up, monitoring, and close-out, while ensuring adherence to GCP, FDA regulations, and ICH‑GCP guidelines.

The role requires 2+ years in clinical research and travel up to 75% within the territory. You will use CTMS tools to track data and coordinate IRB submissions, CAPA, and regulatory compliance.