Study Coordinator

Job Description

Job Description

Description:

Element Research Group (ERG) is a Preclinical Contract Research Organization specializing in functional and performance testing of medical devices, biologics, and drugs throughout all therapeutic areas.

This type of testing can include proof-of-concept, feasibility, demonstrating efficacy though subjective assessment or though statistically powered hypotheses, and demonstrating safety of a particular device or therapy. Performance testing is conducted in animal research models that are anatomically suitable to implant a device and evaluate its use as it is intended to ultimately be used in humans. These tests are often custom designed based on the experience of investigators, available literature, and specific goals for the study.

The study coordinator position is a supportive role to study directors conducting nonclinical studies at ERG. Study coordinators will contribute to the organization and execution of the technical conduct of study procedures, documentation and data collection, and reporting of results.

Element Research Group offers comprehensive medical, dental and vision benefits with additional HSA company contribution, 401K matching, and PTO. Salary range competitive within the med/tech Twin Cities Market.

Job Duties:

• Assist in the development of protocol specific data sheets for essential data capture during the conduct of nonclinical testing.
• Provide medical research services throughout the duration of assigned nonclinical testing as requested by the study director
• Provide consistent, timely, and detailed communication with the client, Element Research Group employees, and various test sites throughout the conduct of a study as requested by the study director.
• Assist in project management of assigned nonclinical studies such as management of external test sites/contractors and ordering study-specific supplies.
• Serve as Principal Investigator for studies in which ERG functions as a test site as requested by Test Facility Management or designee.
• Assist in providing protocol training prior to and/or during study activities for nonclinical studies, as needed.
• Assist in the identification and reporting of study deviations.
• Assist in returning study materials to sponsors or archival of study files after study completion or closure.
• Other tasks as assigned by Testing Facility Management or designee.

Seniority Level will be based on years of experience:

Study Coordinator I: Less than 1 year of study coordinator or related preclinical experience.

Study Coordinator II: Demonstrated proficiency as a study coordinator in complex nonclinical studies and greater than 1 year experience in study coordinator position.

Study Coordinator III: Demonstrated proficiency as a study coordinator in complex nonclinical studies and greater than 3 years experience in study coordinator position.

Education/Experience:

Associates or Bachelor’s Degree in a scientific field

Prior nonclinical research experience is preferred

Experience and applied knowledge may be considered in lieu of a degree

Technical Experience/Knowledge:

Knowledge Good Laboratory Practices guidelines as well as accepted testing standards such as ISO 10993 Biological Evaluation of Medical Devices and other available guidance documents

Ability to communicate effectively with scientists, veterinary care professionals, engineers, physicians, and key opinion leaders

Working knowledge of comparative anatomy and physiology (human and veterinary anatomy), medical procedures, and the function of medical devices

Strong attention to detail and organizational skills

Proficiency in Microsoft Office