Clinical Subjects Associate

University Of Michigan Ann Arbor, MI
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A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

This position is an entry level position and is to provide administrative support and coordination on multiple projects that support faculty members and research teams in the conduct of clinical research projects in the Cancer Center.

Responsibilities*

Enters/submits required information into databases and e-tools in a timely fashion to meet department needs and ensure timely processing of study milestones.

Works closely with staff and research team to ensure/document, regulatory and safety reporting compliance. Collects/prepares appropriate documentation in paper and electronic form (Delegation of Duties signatures, DSM reports, 1572s, AE/SAE attribution and grading, label certifications, IRB rosters, Investigator CVs, Deviation reports Financial Disclosures etc.).

Accurately and precisely complies with designated research protocol requirements, ensuring compliance with SPGs, GCPs, FDA, ICH and IRB regulations/guidelines/policies.

Supports activity such as specimen collection, obtaining signatures, and delivering/collecting equipment and documents requiring regular trips between sites. Activities include scanning research documents into MiChart and shared folders and anything else needed to support Clinical Research.

Required Qualifications*

* Basic understanding of clinical trials or scientific research support and management is needed.

* Must possess IT proficiency, database experience, as well as excellent written and verbal communication skills; self-motivated.

* Demonstrates the ability to thrive in a dynamic fast paced team environment but also able to work independently.

* Flexible and willing/able to work with a variety of teams, physicians and fellow staff members in a team oriented environment to accomplish the research goals of the Oncology- Clinical Trials Support unit (CTSU).

* Demonstrate strong organizational and interpersonal skills with exceptional attention to detail and willingness to contribute in a team environment.

* Driver's License is a requirement.

Desired Qualifications*

* A Bachelor's degree in Science or a Health Science field.

* Understanding of medical terminology is helpful.

* Working knowledge of Human Subjects Regulations governing clinical research is desirable.

* Prior experience with CareWeb, MiChart, e-Research, Carelink a plus.

Background Screening

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.

Mission Statement

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

Application Deadline

Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.

Job Detail

* Job Opening ID 159018

* Working Title Clinical Subjects Associate

* Job Title Clinical Subjects Associate

* Work Location Ann Arbor Campus

Ann Arbor, MI

* Full/Part Time Full-Time

* Regular/Temporary Regular

* FLSA Status Nonexempt

* Organizational Group Medical School

* Department O-CTSU Stdy Coordinator Clinic

* Posting Begin/End Date 6/13/2018 – 6/27/2018

* Paid Time Off Yes

* Career Interest Research

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