Sr. Field Clinical Research Specialist

Position Description:

Sr. Field Clinical Research Specialist for Medtronic 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 Partsand 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 drivers license and be insurable (car insurance).

Basic Qualifications:

Masters 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 Parts812 and ICH-GCP (E6 R2/R3) Compliance; IRB/IEC Submission and approval process; CAPA development and implementation and HIPAA compliance; and 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 drivers license and be insurable (car insurance).

Salary: $128500 to $170400 per year

#LI-DNI

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: 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 and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: 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) and 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

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