[Hiring] Clinical Research Monitor @Medtronic

Role Description 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, closely collaborating with study teams, site personnel, Medtronic field personnel, and monitoring supervisors for resolution of site issues. The Clinical Research Monitor may play a leadership role in managing monitoring activities. This position is remote to enhance competitive edge and expand cross-functional collaboration efforts, requiring 80% travel to ensure successful completion of projects.

• Monitors progress of clinical trials at the site level.
• Ensures trials are conducted, recorded, and reported in accordance with the protocol, SOP, GCP, and other applicable regulatory requirements.
• Develops and maintains liaison with clinical investigators, CROs, affiliated hospitals, and research institutions.
• Responsible for reviewing medical records with investigators.
• Determines and monitors time, budget, schedules, prepares study documents, and issues status reports.
• May assist with design, development, and monitoring of clinical evaluation projects.
• Proposes solutions and collaborates with monitoring management and study team personnel.
• May contact and recommend 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 and current with project requirements.

Qualifications

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

Requirements

• 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 in cross-functional relationships, decision making, execution/results/process improvement, and customer satisfaction.
• Demonstrated ability to maintain composure in difficult circumstances and adapt to shifting priorities.
• 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 applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA, EU Directive).
• Business knowledge or experience with the medical/healthcare industry.
• Class III medical device and/or phase II, III, and IV pharmaceutical experience.
• Experience demonstrating understanding of technical, scientific, and medical information.
• Experience with Regulatory and Quality Assurance audits.
• Experience conducting clinical research activities in a regulated environment.
• Proficient knowledge of medical terminology.
• Scientific/clinical knowledge needed to adequately monitor the trial.
• 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.

Benefits

• Competitive Salary and flexible Benefits Package.
• 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).

Apply tot his job Apply To this Job