MI-AORTA Clinical Research Assistant

3 weeks ago

Ann Arbor, United States University of Michigan Full time

Summary

The MI-AORTA Clinical Research Assistant will work within the Frankel Cardiovascular Center (FCVC) Administration team as part of a multidisciplinary research team involved in the advancement of a cardiovascular disease biobank. You will be responsible for procurement of tissue in the OR setting, transportation of specimen, long-term storage, and classification of specimens obtained during cardiovascular surgeries at Michigan Medicine. This position will assist with study coordination for the biobank, assist with retrospective data reviews, and additional registries, as needed but will not be assigned clinical trials independently.

Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in . Michigan Medicine is comprised of over 30, employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world?s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.

What Benefits can you Look Forward to?  

Excellent medical, dental and vision coverage effective on your very first day Flexible spending accounts Prescription Drug Plan Mental and emotional health programs Child Care Resources Life Insurance Legal Services Plan Retirement Savings Opportunities with 2:1 match and immediate vesting
 

Responsibilities*

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 (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork


Clinical Coordinator Responsibilities

Demonstrate ability to screen research participants for study eligibility & enroll with accuracy in various databases. Utilize clinical and research knowledge to independently resect and obtain tissue from surgical specimens using sterile technique during cardiovascular surgeries at the Frankel Cardiovascular Center for clinical research purposes. Understand protocol structure and how to interpret study requirements to ensure study compliance. 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. 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, CRFs, and requisition forms. Perform other related duties as assigned.


Data Coordinator Responsibilities

Catalogue all tissue collection and report on metrics. Enter data to complete forms (CRFs) in REDCap. Administer minimal risk consents, surveys, and questionnaires. Check own work and confirm accuracy. Assist in quality control efforts.


Administrative Responsibilities

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. Communicate with study participants such as sending study correspondence via email or email. Manage study supply inventory.


Regulatory Coordinator Responsibilities

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


Training

PEERSS, HIPPA, 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. Understand the disease process of the biobank. Attend and participant in all training classes assigned to this level.
 

Required Qualifications*

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. Ability to work well in a fast-paced, high-stress environment. Knowledge of (or ability to learn) sterile technique in the surgical environment.
 

Desired Qualifications*

Associate Degree in Health Science or an 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 years' 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.
 

Modes of Work

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the

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