Sr. Field Clinical Research Specialist

Medtronic • Minneapolis, MN

3d • Remote

About The Position

This is a field-based, customer-facing role for a Sr. Field Clinical Research Specialist at Medtronic, Inc. in Minneapolis, MN. The position involves managing clinical trial sites, providing case coverage (both clinical and commercial), and tracking clinical trial data. The specialist will be responsible for conducting clinical studies in adherence to applicable regulations, guidelines, and policies. Key activities include preparing and revising the Clinical Investigation Plan, preparing study materials, and training investigators, site staff, and Medtronic Field staff. The role requires utilizing Good Clinical Practice (GCP) and regulatory compliance guidelines for clinical trials, including Clinical Trial Design and Execution (Phase I-IV). Responsibilities also encompass coordinating study start-up, site initiation, monitoring, and close-out. The specialist will leverage expertise in the development and review of Informed Consent Forms (ICF), Protocols, and amendments. They will also be responsible for patient recruitment and retention strategies, source document verification (SDV), and Adverse Event (AE) and Serious Adverse Event (SAE) reporting. A deep understanding of various government and industry regulations is essential, 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. The role involves coordinating the Institutional Review Board/Independent Ethics Committee (IRB/IEC) submission and approval process, leveraging Corrective and Preventive Actions (CAPA) development and implementation, and ensuring Health Insurance Portability and Accountability Act (HIPAA) compliance. Experience with Clinical Trial Management Systems (CTMS), Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce is required. The specialist will work within a cardiac catheterization lab, directing physicians, nurses, and ancillary staff on product usage. Travel is required domestically up to 75% within the assigned territory, including the Chicago metro area, IL, and Northwest Indiana, to provide oversight of clinical trials and case support. The position requires working remotely from a home office within the greater Chicago metro area and possessing a valid, insurable driver's license.

Requirements

• Master’s degree in Biological Science, Biology, Nursing, Biomedical Engineering, or Biotechnology
• Two (2) years of experience as a Clinical Researcher or related occupation in clinical research.
• At least two (2) years’ experience with GCP and regulatory compliance guidelines for clinical trials including Clinical Trial Design and Execution (Phase I-IV).
• At least two (2) years’ experience with Clinical study Start-up, site initiation, monitoring, and close-out.
• At least two (2) years’ experience with Review and development of ICF, Protocol, and amendments.
• At least two (2) years’ experience with Patient recruitment and retention strategies, SDV, AE and SAE reporting.
• At least two (2) years’ experience with FDA Regulations 21 CFR Parts 11, 50, 54, 56, 312, 812, and ICH-GCP (E6 R2/R3) Compliance.
• At least two (2) years’ experience with IRB/IEC Submission and approval process.
• At least two (2) years’ experience with CAPA development and implementation, and HIPAA compliance.
• At least two (2) years’ experience with 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).

Responsibilities

• Provide field-based, customer-facing position responsibilities for clinical trial site management, case coverage (clinical and commercial), and clinical trial data tracking.
• Conduct 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.
• Utilize 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.
• Work within a cardiac catheterization lab directing physicians, nurses, and ancillary staff on how to use products.
• 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.
• Work remotely from home office within the greater Chicago metro area.
• Possess a valid driver’s license and be insurable (car insurance).

Benefits

• 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)
• Paid sick time (for temporary employees, as required under applicable state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior