We, the staff and faculty of the Frankel Cardiovascular Center (FCVC) team, are committed to advancing medicine and serving humanity through living and teaching our core values of Caring, Teamwork, Integrity, Innovation and Excellence.  Each FCVC employee is expected to understand and demonstrate that in every interaction we represent our entire organization in the care we provide and in the courtesies we extend to patients, families, and each respective team member.  The FCVC is dedicated to partnering with patients and families to deliver the safest and highest quality of health care.  Excellent service is an expected and integral part of the FCVC culture.

To be considered for this position, a cover letter is required and should be attached as the first page with your resume.  The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

The MI-AORTA Clinical Research Assistant will be part of a multidisciplinary clinical research team within the Frankel Cardiovascular Center (FCVC) Administration, focused on advancing discoveries in aortic disease, with an emphasis on genetics and imaging. This role supports several high-impact research initiatives, including two international registry studies, an aortic imaging collaboration through a consortium, and the collection and classification of aortic tissue for the cardiovascular biobank. Key responsibilities include data entry into international registries, gathering and uploading imaging and clinical data for consortium studies, and specimen procurement in the operating room, as well as transportation and long-term storage of samples. This position does not include independent assignment to clinical trials.

Knowledge of all 8 competency domains is expected and experience within applicable domains specific to unit needs. 

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (Good Clinical Practices)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

20% Clinical Coordinator Responsibilities

• Demonstrate ability to screen research participants for study eligibility & enroll with accuracy in various databases.
• Understand protocol structure and how to interpret study requirements to ensure study compliance.
• Demonstrate understanding of the clinical research objectives associated with the program.
• Understand the importance of participant confidentiality and comply with HIPAA and U of M regulations.
• Demonstrate professional behavior and ethical integrity through the applications of all established processes and procedures related to the ethical treatment of participants.
• Ensure integrity of specimen management (collection, processing, packaging/shipping, storing, labeling, tracking, etc.)
• Prepare study procedure kits, shippers, case report forms (CRFs), and requisition forms.
• Utilize clinical and research knowledge to independently resect and obtain tissue from surgical specimens using sterile techniques during cardiovascular surgeries at the Frankel Cardiovascular Center for clinical research purposes.
• Transport and prepare collected specimens for long-term storage.
• Maintain frozen and fixed tissue biobanks and corresponding databases.
• Assist in preparing tissue for experiments.
• Evaluate research methods and procedures to assess tissue quality.
• Adhere to laboratory safety requirements and guidelines.
• Perform other related duties as assigned.

40% Data Coordinator Responsibilities

• Demonstrates the ability to complete simple data collection during study visits (e.g., basic demographic information).
• Enter data to complete forms (CRFs) on paper or databases.
• Assists with collection of external medical records, Clinical Laboratory Improvement Amendments (CLIAs), Corrective Action Plan (CAPs), and radiology CDs of aortic imaging studies (CTA, MRI, etc.) as assigned.
• Catalogue all tissue collection and report on metrics.
• Demonstrates the ability to find and utilize information from electronic medical record (EMR) and databases/ clinical trial management system (CTMS) / electronic data capture (EDC).
• Administer minimal risk consents, surveys, and questionnaires.
• Check own work and confirm accuracy.
• Assist in quality control efforts.

20% Administrative Responsibilities

• Demonstrates understanding of the clinical research objectives associated with the program.
• Check the study calendar for completion of study procedures.
• Use clinical knowledge to identify patients of interest for tissue collection in order to maintain the balanced overall profile of the biobank with respect to tissue type, pathology, and demographics.
• Independently develop and maintain collaborative relationships with OR staff to facilitate optimal tissue collection.
• Utilize documents and systems to track recruitment and retention of participants.
• Manage study supply inventory.

10% Regulatory Coordinator Responsibilities

• Work with study team to collect essential documents and maintain regulatory compliance.
• Use proper documentation techniques as outlined by the ICH-GCP guidelines.

10% Training

• PEERRS, HIPAA, CITI GCP
• Acquire appropriate training & knowledge of EMR, REDcap and other databases.
• Willing to learn and use available technology and systems to accomplish job requirements.
• Understanding of aortic disease.
• Attend and participate in all training classes assigned to this level.

• High school diploma or GED is necessary.
• Possess ability to maintain a calm, professional demeanor in high-stress, emergent situations.
• Excellent organizational and communication skills.
• Thrives in fast-paced environments, quickly pivoting between tasks while keeping organized and on track.
• Knowledge of (or ability to learn) sterile technique in the surgical environment.
• Demonstrates strong initiative and autonomy while also excelling in team-based settings.

• Associate Degree in Health Science or equivalent combination of related education and experience is desirable.
• An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
• 1-2 year's experience in research laboratory or hospital setting.
• Human anatomy and/or physiology lab coursework or prior experience working with tissue.
• Experience with MiChart and REDCap.

Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings.  Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.

Job openings are posted for a minimum of seven calendar days.  The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.

The University of Michigan is an equal employment opportunity employer.

About University of Michigan - Ann Arbor

A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.

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