Sr. Field Clinical Research Specialist
Medtronic
Summary
Provide field-based, customer-facing position responsibilities for clinical trial site management, case coverage (clinical and commercial), and clinical trial data tracking.
Job description
Responsibilities
- 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 government and industry regulations including U.S. FDA Regulations 21 CFR Parts 11, 50, 54, 56, 312, and 812, and 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 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. 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
- Must work remotely from home office within the greater Chicago metro area
- Must possess a valid driver's license and be insurable (car insurance)
Benefits
- Health, Dental & Vision Insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life Insurance
- Long-term Disability Leave
- Dependent Daycare Spending Account
- Tuition Assistance
- Incentive Plans
- 401(k) Plan
- Short-term Disability
- Paid Time Off
- Paid Holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
Company overview
Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.