Study Director

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 director position is responsible for the overall development, conduct, and reporting of these studies performed for ERG clients. This includes in-depth technical writing, coordinating multiple disciplines, and general knowledge of regulatory requirements. The study director position has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control.

Element Research Group in located in Brooklyn Park, MN and this is an on-site role with 1 day remote as schedule permits. ERG 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:

• Generate customized scientific protocols for assigned GLP or non-GLP nonclinical studies to be conducted at the test facility.
• Develop 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 such as documentation preparation, data collection, experimentation setup, data entry, handling of test and control articles, medical record filing, data monitoring, data presentation, reporting, and client communications.
• Independently complete final reports in a timely manner according to standard operating procedures, the study protocol, and applicable regulations.
• Act as a principal investigator for nonclinical studies to the site IACUC. Prepare submissions and garner approval for the conduct of nonclinical studies with the IACUC. Report any changes, noncompliance, or adverse events to IACUC as applicable during study conduct.
• Serve as a liaison to the sponsor of nonclinical studies being conducted at the testing facility.
• Provide consistent, timely, and detailed communication with the client, Element Research Group employees, and various test sites throughout the conduct of a study.
• Project management of assigned nonclinical studies including establishing study timelines and scheduling, management of external test sites and contractors, and ordering study-specific supplies.
• Maintain an active log of assigned studies and overall status.
• Provide protocol training and/or conduct pre-study meetings prior to study activities for nonclinical studies, as needed. Ensure personnel understand the study activities in which they are to participate in.
• Address Quality Assurance findings for GLP nonclinical studies. Notify management of identified systemic issues. Participate in CAPA process as requested by management.
• Timely archival or appropriate disposition of study materials following completion/closure of studies in accordance with the study protocol and GLP regulations, as applicable.
• Other tasks as assigned by Testing Facility Management or designee.
• Adhere to GLP Regulations and requirements for Role as a Study Director (21CFR58.33):

For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, shall be identified as the study director. The study director has overall responsibility for the technical conduct of the study, as well as for the interpretation, analysis, documentation and reporting of results, and represents the single point of study control. The study director shall assure that:

(a) The protocol, including any change, is approved as provided by § 58.120 and is followed.

(b) All experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified.

(c) Unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented.

(d) Test systems are as specified in the protocol.

(e) All applicable good laboratory practice regulations are followed.

(f) All raw data, documentation, protocols, specimens, and final reports are transferred to the archives during or at the close of the study.

Requirements:

Education/Experience:

A Bachelor’s Degree in a scientific field with a minimum of three years of relevant experience; or

A graduate degree with one year of relevant experience; or

Extensive 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