Research Coordinator - Clinical

Overview

Job Location: Minneapolis with eventual work from home hybrid schedule

Job Status: Full-time (Monday - Friday)

We are seeking a motivated and talented Clinical Research Coordinator to join our busy, fast paced specialty office at Twin Cities Spine Center (TC Spine). Come be a part in our patient's lives and work for an organization that has consistently been named one of the area's Top Workplaces.

The Research Coordinator is a critical role responsible for managing the activities of ongoing research projects and studies that support Twin Cities Spine Center's (TC Spine) research and fellowship programs. Working closely with the Research Director and staff, Surgeon Investigators, and Fellows, this role assists with the development of research studies and is responsible for managing multiple research projects. The Research Coordinator duties include study material preparation, data management, regulatory document preparation, and project coordination in accordance with established protocols, federal and state regulations, and Institutional Review Board (IRB) requirements.

The Research Coordinator also plays a key role in scholarly activity by co-authoring abstracts and manuscripts for submission to conferences and peer-reviewed medical journals. In addition, this role manages research and quality data that supports organizational Quality Assurance and continuous improvement initiatives.

• Co-author and submit abstracts and manuscripts to conferences and peer-reviewed medical journals
• Develop and write research protocols, informed consent forms, grants, and other study related documents
• Prepare and submit Institutional Review Board (IRB) documentation (initial approvals, continuing reviews, adverse event reports, and study closure reports)
• Maintain regulatory binders, source documentation and appropriate forms per protocol
• Perform data abstraction for research studies
• Ensure the accuracy, completeness, and integrity of data
• Maintain research database including validity and consistency assessments
• Learn and implement new technology and software for research (e.g., Outcomes Based Electronic Research Database - OBERD)
• Plan project timelines, milestones and deliverables, then implement and track project progress
• Communicate project status to the Research Director, surgeon investigators and Fellows (study advances or delays with approvals, data collection, patient enrollment, etc.)
• Maintain regular communication with study participants and address any concerns
• Ensure research studies are conducted ethically and in compliance with Federal and state laws
• Respect and protect confidentiality of subjects (HIPAA)
• Screen and enroll study participants (obtain and document Informed Consent)
• Develop and implement strategies for participant recruitment and retention
• Attend weekly Monday conferences in-person
• Work with the other Research Coordinators, the Research Director, surgeon investigators, and Fellows to ensure projects are completed

• Master of Science or Arts Degree or higher, required
• Requires a minimum of 5 years' experience in clinical research
• Proficient with healthcare software (Epic, Next Gen) for research purposes
• Proficient with IRB processes and compliance rules pertaining to research, confidentiality, and HIPAA
• Working knowledge of US Food and Drug Administration (FDA) and state laws and regulations pertaining to clinical trials
• Advanced knowledge of Microsoft Office Suite
• Ability to adapt to different working styles and effectively communicate with staff and providers using excellent interpersonal and verbal/written communication skills
• Ability to pay attention to the smallest details involved in taking service to the next level to deliver high-quality customer service to external/internal customers and communicate with knowledge and compassion
• Ability to effectively manage and prioritize multiple tasks, frequent interruptions, and details with accuracy
• Ability to resolve basic service recovery issues and understand when to escalate to the next level
• Ability to work with people of all ages, ethnicities, and backgrounds

• Medical, Dental, and Vision Insurance
• Group Life and AD&D coverage
• Company Paid Short and Long Term Disability coverage
• Flexible Spending and Health Saving Account options
• 401(k) plan through salary deferrals
• PTO and Paid Holidays

The above description is intended to provide a general outline of some of the basic job requirements and responsibilities and is not all inclusive. Job responsibilities, required skills, and working conditions are also subject to change from time to time.

Twin Cities Spine Center is an Equal Employment Opportunity Employer, and provides reasonable accommodation to qualified disabled individuals in accordance with applicable federal and state law.