Clinical Research Intern

Cleveland, Ohio             ·               Full time

Job description

POSITION TITLE:   Clinical Research Intern

LOCATION:   Cleveland, OH  

REPORTS TO:   Clinical Project Manager

APPROVED/REVISED DATE: 12/2023

Neuronoff is developing the next generation of innovative neuromodulation and implanted electronic devices. Using the Injectrode (injectable-electrode), Neuronoff is establishing a myriad of clinical applications. In these efforts, we are seeking highly motivated currently enrolled students interested in industry clinical research opportunities to assist in clinical trial development at our Cleveland, Ohio, facility near the campus of Case Western Reserve University. This internship provides an excellent opportunity to gain hands-on experience in clinical research within the medical device industry.

Basic Position Objective Statement:

The Clinical Research Intern will support clinical development of the company portfolio of products and innovative therapies, following all the phases of design & development including multiple clinical projects. The role will also collaborate with others on the Clinical Development Team and the Quality/Regulatory and R&D Department Teams under the direct management of the Clinical Project Manager who directly oversees company clinical affairs. The role entails literature review, data entry, documentation and technical writing, assisting in event planning for physician training, and support of clinical study protocols and other critical documents under company Quality Management System.  

This is a hybrid role, with the in-person responsibilities taking place in Cleveland, OH.

Principal Responsibilities and Accountabilities:

• Work with Clinical, QA/RA, and R&D to assist in the execution and analysis of clinical trials for neuro-active implantable medical devices
• Support clinical development of the company portfolio of products and innovative therapies, following all the phases of design & development including multiple clinical projects.
• Actively participate in:
  • literature review of clinical trials and other medical devices.
  • entry of confidential clinical trial data.
  • human clinical trial execution and associated documentation.
  • planning/attendance of company physician training events.
  • assisting with experimental design, documentation and technical writing, including report generation, and support of clinical study protocols and other critical documents under company Quality Management System.
• Other assignments as made by management.

This is not an exhaustive list of duties or functions and may not necessarily comprise all the “essential functions” for purposes of the ADA

Knowledge, Education and Training Qualifications and Certifications:

• Undergraduate or graduate student pursuing a degree in a related field (e.g., biology, neuroscience, biomedical engineering, clinical research, healthcare management, or a similar discipline).

Key Functional Competencies:

• Knowledgeable of FDA (21CFR 820), ISO 14155
• Knowledgeable of HIPAA (Health Insurance Portability and Accountability Act) and healthcare ethics is a plus.
• Strong organizational skills with meticulous attention to detail.
• Excellent communication skills, both written and verbal.
• Excellent interpersonal skills and a spirit of teamwork
• Excellent general and technical communication and presentation skills
• A genuine interest in medical research, clinical trials, and neuromodulation technologies.
• Proficiency in Google applications (Docs, Slides, Sheets).
• Previous experience or coursework related to clinical research is a plus.
• Knowledge of regulatory guidelines and clinical research standards is beneficial but not required.

Key Performance Competencies:

• Demonstrated ability to work effectively within a culture defined by Neuronoff Inc’s core values of achievement, teamwork, innovation and respect.
• Effective verbal and written communication skills are required.
• Excellent communications and influencing skills. Establishes and maintains a high level of credibility.
• Collaborates effectively across the organization; leverages resources from other parts of the organization to build commitment and achieve results. Partners with other leaders and functions to achieve optimal results for Neuronoff, Inc.
• Objectivity; respects other points of view and opinions. Leverages diverse perspectives and experiences to solve problems and develop new approaches.
• Organized; able to handle complexity and multiple priorities. Manages time effectively and focuses on high priority opportunities. Takes measured risks and takes appropriate action in the face of uncertainty.

Licenses/Certifications: GCP (Good Clinical Practice) Training must be completed or will be completed upon employment.

Travel Requirements: 0% – 10% 

Physical Requirements:

The ability to work in a normal office and light manufacturing environment to include: sitting or standing for long periods of time, operating various standard office equipment, carrying paper documents/files, reaching and bending, speaking on the telephone and participating in virtual meetings, able to lift 50lbs, and wearing required personal protection gear (i.e. hearing, eye and foot protection).

Please click here to apply.