Sr. Field Clinical Research Specialist

Medtronic; United States; Remote; USD 129,000 - 170,000; Full time

Benefits offered by this job

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

Job summary

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.

Responsibilities

• 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.

Skills

GCP compliance

Clinical trial design

Site initiation

Monitoring

SDV

AE/SAE reporting

IRB submission

CAPA

HIPAA

CTMS systems

Education

Master's degree in Biological Sciences

Tools

CTMS

Veeva Vault CTMS

Oracle Siebel CTMS

Salesforce

Job description

Position Description:

Sr. Field Clinical Research Specialist for Medtronic, Inc. in Minneapolis, MN. Provide field-based, customer-facing position responsibilities for clinical trial site mgmt., case coverage (clinical and commercial), and clinical trial data tracking. Responsible for conducting clinical studies with adherence to applicable regulations, guidelines, and policies. Prepare and revise Clinical Investigation Plan. Prepare study materials and/or training of investigators, site staff and Medtronic Field staff. Responsible for utilizing Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials including Clinical Trial Design and Execution (Phase I-IV). Coordinate Study Start-up, site initiation, monitoring, and close-out. Leverage Informed Consent Form (ICF), Protocol and amendments development and review. Responsible for Patient recruitment and retention strategies, source document verification (SDV), Adverse event (AE) and Serious adverse event (SAE) reporting. Navigate the complexities of various government and industry regulations including U.S. FDA Regulations 21 CFR Parts 11, 50, 54, 56, 312, and 812, and International Council for Harmonization - Good Clinical Practice (ICH-GCP) E6 R2/R3 Compliance. Coordinate the Institutional Review Board/Independent Ethics Committee (IRB/IEC) submission and approval process. Leverage Corrective and Preventive Actions (CAPA) development and implementation as well as Health Insurance Portability and Accountability Act (HIPAA) compliance. Clinical Trial Mgmt. Systems (CTMS), Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce. Work within a cardiac catheterization lab directing physicians, nurses, and ancillary staff on how to use products. #LI-DNI

Travel domestically up to 75% within assigned territory including Chicago metro area, IL, and Northwest Indiana to provide oversight of clinical trials and case support. Must work remotely from home office within the greater Chicago metro area. Must possess a valid driver's license and be insurable (car insurance).

Basic Qualifications:

Master's degree in Biological Science, Biology, Nursing, Biomedical Engineering, or Biotechnology and two (2) years of experience as a Clinical Researcher or related occupation in clinical research.

Must possess at least two (2) years' experience with each of the following:

• GCP and regulatory compliance guidelines for clinical trials including Clinical Trial Design and Execution (Phase I-IV)
• Clinical study Start-up, site initiation, monitoring, and close-out
• Review and development of ICF, Protocol, and amendments
• Patient recruitment and retention strategies, SDV, AE and SAE reporting
• FDA Regulations 21 CFR Parts 11, 50, 54, 56, 312, 812, and ICH-GCP (E6 R2/R3) Compliance
• IRB/IEC Submission and approval process
• CAPA development and implementation, and HIPAA compliance
• CTMS, Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce

Requires travel domestically up to 75% within assigned territory including Chicago metro area, IL, and Northwest Indiana to provide oversight of clinical trials and case support. Must work remotely from home office within the greater Chicago metro area. Must possess a valid driver's license and be insurable (car insurance).

Salary:

$128,500 to $170,400 per year

• Health
• Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program).

• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans