Sr. Field Clinical Research Specialist

Medtronic•Minneapolis, MN

3d•Remote

About The Position

Provide field-based, customer-facing position responsibilities for clinical trial site management, 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 Management 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. Must work remotely from home office within the greater Chicago metro area. Must possess a valid driver’s license and be insurable (car insurance).

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.
Manage Patient recruitment and retention strategies, source document verification (SDV), Adverse event (AE) and Serious adverse event (SAE) reporting.
Navigate 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 Management 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)
Medtronic Employee Referral Bonus Program ($1,000)