Clinical Research Associate II

Description

Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.

The Clinical Research Associate (CRA) II is an individual contributor participating in the execution of clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Clinical Standard Operating Procedures with a dedicated focus on monitoring, data review, and site management activities. Able to solve a range of straightforward problems and analyze possible solutions using standard procedures.

This is an onsite position, requiring a full-time in-person presence at Nuwellis' corporate office in Eden Prairie, MN.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Supports Clinical Management in key study execution tasks and provides regular updates to management.
• Independently conduct site monitoring tasks and manages study sites throughout study start-up, enrollment, execution, and closeout phases of clinical trials. Independently coordinates monitoring assignments and meets the expectations for completion of monitoring activities and submission of monitoring reports.
• Adheres to study protocols and monitoring plans (e.g., monitoring visit type, frequency, and required critical monitoring activities). Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review)
• Ensures regulatory and clinical protocol compliance for all assigned clinical projects and manages site-specific corrective and/or preventative action plans, as applicable. Ensure the Investigator and site staff adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies, and standard operating procedures.
• Provide recommendations and guidance to study specific monitoring teams and assist in audit readiness and preparation.
• Participate in regular monitoring team group meetings.
• Responsible for site start-up requirements, collecting required regulatory documentation, and supporting IRB submissions to activate sites for enrollment.
• Reviews site-specific informed consent documents to ensure all required elements are included.
• Assist with negotiation of study budgets and supports clinical trial agreement execution.
• May assist with development of study-specific materials such as document templates (e.g., regulatory binder logs, etc.), patient recruitment materials, and study supplies.
• Supports activities with study specific committees, vendor services, and/or core labs.
• Tracks subject enrollment and follow-up visits at study sites.
• Train study sites on clinical trial protocols and support Investigator meetings, as applicable.
• Supports clinical document reviews (e.g., document templates, checklists, and clinical SOPs) for accuracy, completeness, and alignment with current regulatory requirements, as applicable.

Requirements

MINIMUM QUALIFICATIONS

• Bachelor's degree in Science, Nursing, or related field.
• Four years of onsite clinical monitoring experience.

PREFERRED QUALIFICATIONS & COMPETENCIES

• Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).
• Good understanding of current clinical regulations and common industry practices (e.g., GCPs and FDA regulations).
• Written and verbal communication, interpersonal, presentation, analytical, organizational skills.
• Ability to interpret basic clinical data and to meet deadlines.
• Ability to communicate effectively with all levels of employees.
• Familiarity with Microsoft Word, Excel and Outlook programs and relevant clinical applications.
• The ability to work independently when necessary.

WORKING ENVIRONMENT

• There is significant work pace & pressure due to deadlines.
• There is approximately 50% travel expected.

Base salary range for this position is between $80,000-$100,000, with bonus potential. The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Nuwellis, Inc. offers a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees, subject to the terms and conditions of the applicable plans.