Clinical Research Monitor (CRA)

Clinical Research Monitor

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with applicable regulatory standards, IRB/EC policies and procedures and Business requirements. This position works under minimal supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. The Clinical Research Monitor may play a leadership role in managing monitoring activities.

At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 80% of travel to enhance collaboration and ensure successful completion of projects.

Responsibilities may include the following and other duties may be assigned.

• 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.
• Responsible for reviewing medical records with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
• May assist with design, development, and monitoring of clinical evaluation projects.
• Propose solutions and collaborate with monitoring management and study team personnel towards securing Investigator compliance
• May contact and recommend qualified investigators to perform studies and initiate clinical trials.
• Ensures recruitment and retention of patients.
• Mentor and/or train junior personnel
• Assist site/study teams with audit preparation
• Author Monitoring Plans and other study materials
• Ensures monitors are trained, current with project requirements and understand study milestones

Must Have:

• Bachelor's degree plus a minimum of 4 years of experience monitoring clinical trials (or advanced degree with 2+ years)

Nice to Have:

• Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• Practical knowledge of project management
• Clinical experience
• Knowledge of/experience with CTMS/EDC/eTMF/Veeva Vault
• Experience with Good Clinical Practice (GCP)
• Excellent interpersonal skills
• Experience working in a team/matrix environment requiring strong working relationships
• Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
• Ability to work in a fast-paced environment
• Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
• Demonstrated ability to maintain composure in difficult circumstances and to identify and adapt to shifting priorities and competing demands.
• High attention to detail and accuracy
• Experience working independently in a regional area with remote or minimal supervision
• Strong leadership skills
• Excellent problem-solving skills
• Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
• Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.)
• Business knowledge or experience with the medical / healthcare industry
• Class III medical device and/or phase II, III and IV pharmaceutical experience
• Experience to demonstrate understanding of technical, scientific and medical information
• Experience with Regulatory and Quality Assurance audits
• Experience of conducting clinical research activities in a regulated environment
• Proficient knowledge of medical terminology
• Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)
• Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.?

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain, restore health, and extend lifewhere your unique background and perspective are valued.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$86,400.00 - $129,600.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

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

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people. We are engineers at heart