Clinical Research Coordinator II-Dermatology

University of Wisconsin Madison • Madison, WI

3d • Hybrid

About The Position

The Department of Dermatology seeks an experienced Clinical Research Coordinator II to support the clinical research of Dr. Beth Drolet and Dr. Bridget Shields. This position will join our team of world-renowned researchers and investigators committed to basic, clinical, and translational research designed to address dermatologic diseases and other skin-related research questions. The successful candidate will play a pivotal role in contributing to the conduct of state-of-the-art skin disease research to advance scientific knowledge and thus provide better care to patients. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. The Department of Dermatology is committed to advancing cutting-edge research, training the next generation of leaders, and delivering world-class patient care for individuals of all ages. Guided by our vision to be a world leader in academic dermatology, we strive to be a center for remarkable care and a vibrant community dedicated to innovation, education, and inclusion. We embrace both independent and collaborative approaches to our work. Our philosophy is to empower individuals through comprehensive, hands-on training and onboarding, while fostering a strong team culture through regular collaboration with colleagues and support staff across the department.

Requirements

• 1-2 years working in a research or clinical research or clinical trials environment required.
• Experience in project management, including the ability to manage several projects at one time
• Experience working with people from varying professions and backgrounds including collaborators, participants and families
• Strong oral and written communication skills.
• Ability to interact well with patients and researchers independently, facilitating problem-solving in difficult situations.
• Strong attention to detail.
• Ability to use good initiative and judgement.
• Ability to structure time to meet multiple deadlines.
• Proficiency with Word, Excel, PowerPoint, Outlook, scheduling and project management tools such as Smartsheet.

Nice To Haves

• Experience with clinical research regulations, including OHRP, CTMS, GCP preferred
• Demonstrated experience in scheduling, coordinating, and conducting visits and study meetings preferred
• Experience in approaching patients to discuss clinical trials and their potential participation, and obtaining informed consent preferred.

Responsibilities

• Protocol Development and Management: Collaborate on research protocols and ensure compliance.
• Regulatory Compliance and Ethics Oversight: Ensure adherence to regulations and ethical standards.
• Participant Recruitment and Consent Management: Strategize recruitment strategies and manage informed consent processes.
• Data Oversight and Quality Control: Oversee data collection, verification, and maintain quality control.
• Site Coordination and Monitoring: Coordinate site activities, conduct monitoring visits, and ensure safety.
• Communication and Reporting: Serve as the main contact, communicate study progress, and generate reports.
• Collaborates with departmental and institutional clinical research teams and resources, performing administrative duties such as clinical research finance needs and assisting with training of staff to support study conduct and compliance
• Serves as a main point of contact for clinical research participants, providing information regarding research procedures, expectations, and informational inquiries.
• Ensures participants follow the research protocol and alerts Principal Investigator of issues
• Manages regulatory and compliance activities, including preparing and submitting protocols and amendments to Institutional Review Boards (IRBs), coordinating and executing Data Transfer Agreements (DTAs) and Material Transfer Agreements (MTAs), and ensuring all study activities comply with institutional, federal, and sponsor requirements
• Identifies work unit resources needs and manages supply and equipment inventory levels
• Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols
• May assist with training of staff
• Identifies resource needs and develops clinical research documents, such as job aids, tools, processes, procedures, and training.
• Contributes to the development of protocols
• Recruits, screens, selects, determines eligibility and enrolls trial participants, collects more complex information, performs medical assessments, and answers varied questions under supervision of a medically licensed professional.
• Performs medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy
• Performs quality checks
• Schedules logistics, determines workflows, and secures resources for clinical research trials

Benefits

• Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level