Clinical Trial Assistant

Endogenex, Inc.; Minneapolis (MN); On-site; USD 52,000 - 70,000; Full time

Job summary

Endogenex, Inc. is seeking a Clinical Trial Assistant to organize and document our clinical studies. You will maintain the trial master file, log and quality-check study documents, and keep the CTMS current while coordinating meetings and site communications.

This role reports to the Director of Clinical Affairs and collaborates with the clinical operations team, investigative sites, and vendors. We provide training on regulatory aspects and offer an opportunity to move into clinical research.

Qualifications

• Bachelor's degree in life science, nursing, healthcare administration, or related field.
• At least 1 year of experience in clinical research, medical device/pharma setting, or healthcare coordination.
• Strong attention to detail and organizational skills for records review.

Responsibilities

• Maintain trial master file and study documents per GCP/SOPs.
• Log, quality-check, and reconcile CRFs and study documents.
• Coordinate CTMS updates and trial progress tracking.
• Support investigator/site payments and site communications.
• Prepare meeting minutes and coordinate Investigator Meetings.
• Attend project team meetings and assist with meeting materials.

Skills

Attention to detail

Organizational skills

Written & verbal communication

Microsoft Office

Task management

Education

Bachelor's degree in life sciences or healthcare

Tools

CTMS

EDC

Job description

Endogenex is a medical technology company founded in partnership with Mayo Clinic. We are developing a treatment for type 2 diabetes that targets the duodenum — the first part of the small intestine — which research now points to as a likely contributor to the disease. Our minimally invasive, outpatient procedure uses non-thermal pulsed electric fields to treat inflamed tissue and support healthy cell regeneration, with the goal of altering how the disease progresses rather than managing its symptoms. We are a small team in Plymouth, Minnesota, and we are running the clinical trials that will show whether this works.

PRIMARY FUNCTION

The Clinical Trial Assistant keeps our clinical studies organized and documented. You will maintain the trial master file, log and quality-check study documents, keep the clinical trial management system (CTMS) current, coordinate meetings and site communications, and make sure our records would stand up to an inspection. When a monitor or an auditor asks where something is, you are the person who knows.

Position reports to the Director of Clinical Affairs and work closely with the clinical operations team, investigative sites, and vendors. This is a strong role for someone with early clinical research experience, or for someone with solid administrative and organizational skills in a healthcare setting who wants to move into clinical research. We will teach you the regulatory side.

RESPONSIBILITIES

Study documentation and records

• Follow Good Clinical Practice (GCP), applicable regulations, Company Standard Operating Procedures (SOPs), and internal tracking requirements in everything you do.
• Assist project teams with study-specific documentation and guidelines.
• Set up, organize, and maintain the trial master file and other clinical study documentation, including preparation for internal and external audits, final reconciliation, and archival.
• Log, track, and quality-check case report forms (CRFs) and other study documents.
• Perform quality control audits of clinical study documentation.
• Coordinate the ordering, shipment, and tracking of trial materials and study supplies to investigative sites.
• Assist project teams with trial progress tracking by updating the Clinical Trial Management System (CTMS).

Coordination and communication

• Provide day-to-day administrative support to the Clinical Affairs team.
• Support investigator and site payments by gathering the documentation the Finance team needs.
• Contact clinical sites for specific requests, such as enrollment updates, missing documentation, meeting arrangements, etc.
• Assist in the tracking and distribution of safety reports.
• Coordinate document translation when required.
• Attend project team meetings and generate meeting minutes.
• Assist the Project Manager and project team with Investigator Meeting coordination, activities preparation, and generate meeting minutes.
• Help prepare slides and materials for project and departmental meetings.
• Other duties as assigned.

QUALIFICATIONS

• Bachelor's degree in a life science, nursing, healthcare administration, or a related field, or an equivalent combination of education and experience.
• At least one year of experience in clinical research, at a medical device or pharmaceutical company, or in a healthcare setting. We will also consider candidates with strong administrative or coordinator experience in healthcare who want to move into clinical research.
• Strong attention to detail and organizational skills. You will own records that a monitor or an auditor may review.
• Clear written and verbal communication, and comfort working directly with investigative sites, vendors, and internal teams.
• Proficiency with Microsoft Office.
• Ability to manage several open tasks at once and follow each one through to completion.

PREFERRED SKILLS

• Experience with an electronic data capture (EDC) system or a clinical trial management system (CTMS).
• Data analysis skills.
• Familiarity with Good Clinical Practice (GCP), ISO 14155, and 21 CFR regulations for clinical research.
• Experience supporting a medical device trial or an investigational device exemption (IDE) study.

EQUAL OPPORTUNITY

Endogenex is an Equal Opportunity Employer. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. If you need a reasonable accommodation to apply or to interview, tell us and we will work with you.

WORKING CONDITIONS

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to handle or feel objects, tools or controls; reach with hands and arms; balance; stoop; talk and hear. Specific vision abilities include close and distance vision. Ability to occasionally lift and/or move up to 35 lbs.
• Work environment: Fast paced work environment. While performing the duties of this job, the employee will experience in/out of the office noise at a minimal level. Travel is minimal and expected to be under 10%.