Position Description:
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).
NOTICE: Pursuant to 20 C.F.R. § 656.10, you are hereby notified that an Application for Permanent Employment Certification will be filed for the job opportunity below. Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer at the U.S. Department of Labor as follows:
Certifying Officer
U.S. Department of Labor
Employment and Training Administration
Office of Foreign Labor Certification
200 Constitution Avenue NW, Room N-5311
Washington, DC 20210
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; 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 driver’s license and be insurable (car insurance).
The position reports to Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432.
Salary: $128,500 to $170,400 per year
THIS POSITION QUALIFIES FOR THE MEDTRONIC EMPLOYEE REFERRAL BONUS PROGRAM AT THE LEVEL OF $1,000. Refer to the program guidelines located at myworkday.com/medtronic. Go to: Menu > Jobs Hub > Refer a Candidate
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:
https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic
#LI-DNI