Clinical Research Monitor (CRA)

Medtronic•Minneapolis, MN

1d•$86,400 - $129,600•Remote

About The Position

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. 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.

Requirements

Bachelor’s degree plus a minimum of 4 years of experience monitoring clinical trials (or advanced degree with 2+ years)
Applied understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical ethics, HIPAA and patient privacy laws, EU Directive, etc.)
Experience with word processing, spreadsheets, and databases applications (e.g., MS Word and Excel)
Strong leadership skills
Excellent problem-solving skills
Ability to work in a fast-paced environment
Ability to handle and prioritize multiple therapeutic areas and projects simultaneously
Experience working in a team/matrix environment requiring strong working relationships
Excellent interpersonal skills
Experience with Good Clinical Practice (GCP)
Knowledge of/experience with CTMS/EDC/eTMF/Veeva Vault
Practical knowledge of project management
Clinical experience
Advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
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
Competencies and essential skills in the following: cross functional relationships, decision making, execution/results/process improvement, customer satisfaction
Scientific/clinical knowledge needed to adequately monitor the trial (e.g. general therapeutic area education and training)
Regulations/standards training (FDA, ISO, GCP and other country specific training, such as for Canada, Asia, Latin American, etc. as applicable)
Proficient knowledge of medical terminology
Experience with Regulatory and Quality Assurance audits
Experience of conducting clinical research activities in a regulated environment
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

Nice To Haves

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.

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.
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

Benefits

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
Simple Steps (global well-being program)
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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)