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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, along with three references. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.

Job Summary

Highly motivated individual sought for a full-time clinical research coordinator healthcare position within the Department of Emergency Medicine Division of Critical Care at Michigan Medicine. The candidate will serve as a clinical research coordinator for multiple studies (including clinical trials and human subject’s studies), will work closely with Division of Critical Care leadership and faculty, and will support a robust and growing clinical and human studies research program.

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.

Responsibilities*

Responsible for all aspects of research regulatory compliance, such as preparation/writing of IRB protocols for submission and maintenance (including the initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.), while ensuring effective routine communication with the IRB. Create and maintain study standard operating procedures/protocols and research binders. Perform literature reviews. Completion of study tracking documentation accurately and in a timely manner. Create and routinely update project tracking systems. Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements.

 

Responsible for all aspects of research study coordination: Identifying/pre-screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects, consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting follow-up assessments. Coordination of specimen collection and storage. Monitor subjects for safety and compliance with protocols. Coordination/management of all daily study operations.

 

Effectively update study sponsors on annual progress of research projects. Will be responsible for working with various groups to execute legal contracts (where appropriate). May reconcile study expenses, communicate/negotiate with study sponsor, the IRB, investigational pharmacy, referring doctors, CTSUs, and additional units (such as the Michigan Clinical Research Unit (MCRU) team). This position will also assist with coordination of research meetings, additional research initiatives, and collaborating within Emergency Medicine and across Michigan Medicine. May act as liaison with other departments, divisions, and organizations.

 

Responsibility for the management/maintenance of large, secured research databases to include all subject data, records, and documentation, data entry/extraction, and routinely perform data-quality checks. Work closely with data analyst(s) to ensure data integrity and alignment with study protocols. Work with faculty and staff to efficiently manage multiple data capturing systems. Create and organize data into easily manageable spreadsheets, tables, and graphs for periodic presentations to study staff and investigators, and for regulatory bodies including the NIH and IRBMED. May assist with data

analyses/interpretation of results, in addition to preparing project reports or publications, and presenting updates as appropriate.

 

May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluates results. Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions. Consults with study staff to refine or adapt methodologies to fit research goals and specific aims. Collaborates in development of new techniques and procedures/protocols.

 

Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality. Regular active participation in research meetings will be expected.

 

Diversity, equity, and inclusion ongoing education will be required, and demonstration of cultural awareness and humility will be always expected when interacting with faculty, study staff, research participants and families, from diverse backgrounds.

 

This position will assist with clinical trials within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will routinely require covering some evening and weekend shifts. Cross training with other staff will be required.

 

Additional work-related tasks, not specifically outlined above, will be required of the candidate.

Required Qualifications*

College degree preferably in natural sciences, human sciences, social science, health-related field, or related field, with 1-3 years of experience or equivalent education and experience.

 

Excellent interpersonal, oral, and written communication skills with exceptional attention to detail. Must be organized, efficient, self-motivated, and proficient in computer skills including Microsoft software applications. Ability to organize and manage multiple tasks/projects simultaneously, as well as prioritize and exercise good judgment. Ability to work independently with minimal supervision while maintaining effective collaborations and communication with a diverse team of individuals in a diplomatic, professional, collaborative, and effective manner. Candidate will be expected to prioritize multiple tasks, meet deadlines, and adhere to strict confidentiality policies. Must be comfortable working in the Emergency Department (following established protocols to facilitate social distancing and reduce COVID-19 transmission risks), interacting with diverse populations, and potentially discussing sensitive topics with study participants and families.

Desired Qualifications*

Previous clinical research experience, clinic/hospital work or volunteer experience, and knowledge of the research protocols and processes are highly desired. The ideal candidate for this position will be able to work as a member of a collaborative team but have the ability to function independently with limited supervision after a period of on-boarding. Familiarity and experience with Epic, MiChart and eResearch applications. PEERS, regulatory compliance, IRB review and approval process, CITI or NIH Protection of Human Subjects Training Certification is preferred. Experience with REDCap (Research Electronic Data Capture), Qualtrics or a similar data capturing system and statistical methods background and responsibilities in previous employment is also preferable.

Work Schedule

This position will assist with clinical trials within the Michigan Medicine Department of Emergency Medicine. While the primary work schedule will be Monday through Friday, due to the nature of our patient care, this position will require flexibility and will routinely require covering evening and weekend shifts.

Underfill Statement

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.

Additional Information

The Department of Emergency Medicine at Michigan Medicine is committed to creating an environment that is welcoming to all. We strive to value the unique contributions of individuals, and support a culture of inclusivity among our employees, learners, and larger community. This includes supporting the development of a diverse workforce across identities such as race, ethnicity, national origin, sexual orientation, gender identity, age, citizenship, marital status, religion, language, disability, and Veteran status. We are proud to be an equal opportunity and an affirmative action employer.

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. 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.

Application Deadline

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.

U-M EEO/AA Statement

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

 

U-M COVID-19 Vaccination Policy

COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine, by the start of the fall term on August 30, 2021.  This includes those working or learning remotely.  More information on this policy is available on the Campus Blueprint website or the U-M Dearborn and U-M Flint websites.