Senior Clinical Research Monitor (CRA) at Medtronic

Fridley, Minnesota, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s degree plus a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience (nice to have)
Practical knowledge of project management (nice to have)
Clinical experience (nice to have)
Knowledge of/experience with CTMS/EDC/eTMF/Veeva Vault (nice to have)
Experience with Good Clinical Practice (GCP) (nice to have)
Excellent interpersonal skills (nice to have)
Experience working in a team/matrix environment requiring strong working relationships (nice to have)
Ability to handle and prioritize multiple therapeutic areas and projects simultaneously (nice to have)
Ability to work in a fast-paced environment (nice to have)
Competencies and essential skills in cross functional relationships, decision making, execution/results/process improvement, customer satisfaction (nice to have)
Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands (nice to have)
High attention to detail and accuracy (nice to have)
Experience working independently in a regional area with remote or minimal supervision (nice to have)
Strong leadership skills (nice to have)
Excellent problem-solving skills (nice to have)
Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel) (nice to have)
Applied understanding of applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA) (nice to have)

Responsibilities

Monitors progress of clinical trials at the site level and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements
Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval
Reviews medical records with investigators, determines and monitors time, budget, schedules, prepares study documents, and issues status reports
Assists with design, development, and monitoring of clinical evaluation projects
Proposes solutions and collaborates with monitoring management and study team personnel towards securing Investigator compliance
Contacts and recommends qualified investigators to perform studies and initiate clinical trials
Ensures recruitment and retention of patients
Mentors and/or trains junior personnel
Assists site/study teams with audit preparation
Authors Monitoring Plans and other study materials
Ensures monitors are trained, current with project requirements and understand study milestones
Oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements
Works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues
May play a leadership role in managing monitoring activities

Skills

Clinical Research

GCP

SOP

Protocol Compliance

Site Monitoring

IRB/EC

CRO Management

Investigational Studies

Medical Devices

Regulatory Compliance

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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