Merit Medical Systems, Inc.
About the job
SUMMARY OF DUTIES*
Provides advanced support for the tracking of clinical trial-related documents or materials, maintaining the trial master file, and assisting in the development of tools to help in the conduct of clinical trials.
Essential Functions Performed
- Maintains multiple tracking spreadsheets following the progress of assigned clinical trials, such as essential document tracking, investigational product tracking, and trial supply tracking
- Constructs trial master file folders and is responsible for filing and maintaining up-to-date study documents.
- Orders, prepares, packages, and sends documents and materials to clinical trial sites and vendors as needed.
- Provides support to imaging centers, labs, supply, and other study vendors.
- Receives and reviews all regulatory documents from sites for accuracy and compliance to company SOPs and federal guidelines track all information for reference and maintain documentation as required. Ensure that regulatory documents are updated in a timely and appropriate manner.
- Performs in-house duties to assist monitors responsible for sites located outside of the United States.
- May attend site visits to assist monitors, when applicable.
- Assists with the development of site tools and clinical trial start-up activities.
- Provides general support to the Medical Affairs team.
- Performs other related duties and tasks, as required.
Summary Of Minimum Qualifications
- Education and/or experience equivalent to a bachelor’s degree in a scientific discipline and four years of related experience.
- Knowledge of FDA, ISO 13485, SOP, MDD standards, and GMP requirements within the medical device industry.
- Knowledge of Good Clinical Practice Regulations and ICH guideline
- Demonstrated human relations and effective communication skills — verbal and written.
- Demonstrated computer skills preferably spreadsheets, word processing, database, and other applicable software programs.
- Strong organizational skills and the ability to be self-motivated and be detailed oriented.
- Ability to travel up to 10%
- Document packaging and coordination for:
- Regulatory submissions (domestic and international)
- Medical Device Reports
- Clinical trials
- Company policies and procedures
- Management/external agency/company interaction.
- Project task team participation
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. To see what it is like to work at Merit take a look at our new recruiting video on YouTube at www.youtube.com/meritmedical to see the video titled “Great people, Great products, Great Company”. Merit currently has the above opening located in South Jordan, Utah. Excellent compensation and benefits packages will be offered to the right candidate.
COMPANY HISTORY Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. Merit also develops and markets embolotherapeutic products for the treatment of uterine fibroids, hypervascularized tumors, and arteriovenous malformations. Embolotherapy procedures are primarily performed by interventional radiologists and use bioengineered microspheres to create targeted vascular occlusion and drug delivery. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
EQUAL OPPORTUNITY EMPLOYER M/F/D/V