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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*

Assists PI in ensuring that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures; Assists PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training; Assists PI in assuring that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections; Assists PI in communication of study requirements to all individuals involved in the study; assists the PI in providing appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log; Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.); Works with the PI to develop and implement recruitment strategies in accordance with IRB requirements and approval; Conducts or participates in the informed consent process including interactions with the IRB and discussions with research participants, including answering any questions related to the study; Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed; Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion; Registers participants and enters data into the electronic database system maintained at the coordinating center (if multi-site study); Registers each participant in the OnCore system to ensure billing of study procedures to the appropriate funding source; Coordinates participant tests and procedures; Collects data as required by the protocol. Assures timely completion of case report forms and data entry; Maintains study timelines; Maintains adequate inventory of study supplies; Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms; Retains all study records in accordance with sponsor requirements and University policies and procedures; Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study; Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management; Maintains study essential documents binders.

 Reviews and comprehends the protocol; Attends investigator meetings and training sessions as required or requested by the PI; prepare IRB and any other regulatory submission documents as required by the protocol; May prepares other study materials as requested by the PI; These study materials include but are not limited to the informed consent document; case report forms (CRFs), enrollment logs, and drug/device accountability logs; Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Along with the GLEMSCRN Team, is is responsible for ensuring that all staff are trained on: Study protocols and procedures; Conduct of Informed Consent; University of Michigan Program for Education and Evaluation in Responsible Research and Scholarship (PEERS); University IRBMED Workshops; Specimen handling and shipping; University of Michigan electronic medical record systems; All pertinent PECARN DCC related training activities

Required Qualifications*

• A bachelor’s degree in a health science discipline, such as biochemistry, anatomy, pathology, nursing, medical technology, public health, research administration or equivalent; • Excellent interpersonal skills; • Self-starter and ability to work independently; Ability to work well with others in a team environment; • Excellent time management skills; • Day, afternoon, evening and weekend availability • 

Desired Qualifications*

• Some experience in conducting clinical research, data collection, and data analysis

Work Schedule

• Some experience in conducting clinical research, data collection, and data analysis

Work Schedule

This is a 40-hour-per-week job which will include night and weekend hours. Coverage hours range from 10:00 AM to midnight, seven days per week. Morning, evening, and weekend hours will be required Travel: Applicant must be able to travel for training at locations throughout the continental United States.

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.  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.