Sr. Field Clinical Research Specialist
About The Position
This is a field-based, customer-facing position for a Sr. Field Clinical Research Specialist at Medtronic, Inc. in Minneapolis, MN. The role involves clinical trial site management, case coverage (clinical and commercial), and clinical trial data tracking. The specialist will conduct clinical studies in adherence to applicable regulations, guidelines, and policies. Responsibilities 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 (Phase I-IV), coordinating study start-up, site initiation, monitoring, and close-out. The specialist will leverage Informed Consent Form (ICF), Protocol, and amendments development and review, and be responsible for patient recruitment and retention strategies, source document verification (SDV), and Adverse event (AE) and Serious adverse event (SAE) reporting. The position requires navigating 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. Coordination of the Institutional Review Board/Independent Ethics Committee (IRB/IEC) submission and approval process, Corrective and Preventive Actions (CAPA) development and implementation, and Health Insurance Portability and Accountability Act (HIPAA) compliance are also key. Experience with Clinical Trial Management Systems (CTMS), Veeva Vault CTMS, Oracle Siebel CTMS, and Salesforce is necessary. The role involves working within a cardiac catheterization lab, directing physicians, nurses, and ancillary staff on product usage. Travel domestically up to 75% within the assigned territory (Chicago metro area, IL, and Northwest Indiana) is required for clinical trial oversight and case support. The position requires working remotely from a home office within the greater Chicago metro area and possessing a valid driver's license and insurability.
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 mgmt., 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.
- Utilize 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.
- 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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
