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500 S State St, Ann Arbor, MI 48109, USA

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"Study Coordinator (1 yr Term Limited)"

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Study Coordinator (1 yr Term Limited)

The Mood Disorder Program of the Department of Psychiatry is seeking a Clinical Research Technician to assist with several clinical research projects in mood disorders, including maintaining an interventional psychiatry research registry as well as working with senior faculty and research personnel in organizational and administrative details pertaining to clinical trials. This work will focus on recruitment activities, data entry, and maintenance of research databases. Interaction with adults with mood disorders will be a significant component.

Characteristic Duties and Responsibilities:

  • Experience as part of a team with all 8 competency domains is expected: Scientific Concepts and Research Design, Ethical Participant Safety Considerations, Investigations Products Development and Regulation, Clinical Study Operations (GCPs), Study and Site Management, Data Management and Informatics, Leadership and Professionalism, Communication and Teamwork.
  • Additional Responsibilities: Coordinate with various interventional psychiatry clinics and the depression and bipolar clinics for patient recruitment; Enter data and provide ongoing maintenance activities with key research databases, primarily using REDCap, Excel, and Qualtrics; Assist in maintenance of documents and progress reports for the IRB; Run reports in the Electronic Medical Record (MiChart) to identify candidates for research and to collect data; Assist faculty and research staff in scheduling, screening, and consenting individuals for research studies; Coordinate study visits and follow-up of study participants; Assist in the administration of questionnaires and surveys, both paper and electronic, to research participants; Communicate with external partners such as study sponsors or outside academics who are involved in the research projects; Collect data, file hardcopies and enter data into appropriate electronic systems; Perform other study procedures as required by study protocols, such as taking vital signs, taking individuals to the lab for blood collection, etc.

Required Education/Experience Qualifications: Associate's degree in health science or an equivalent combination of related education and experience is necessary. ONE of the following: Minimum 1 years of directly related experience in clinical research and clinical trials is necessary; An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD; Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.

Additional Qualifications: Experience with patients with mood disorders; Experience in administering scales or questionnaires; Proficiency in Microsoft programs including Windows, Outlook email/calendaring, Excel, Powerpoint, Word; Experience with various electronic tools including Dropbox, Qualtrics, REDCap, Medidata; Basic knowledge of U-M research activities, including the IRB; Outstanding oral and written communication skills and organizational skills emphasizing detail, accuracy; Ability to handle multiple tasks in fast-paced office environment.

Desired Education/Experience Qualifications: Bachelor's degree in a 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.

Additional Desired Qualifications: Academic knowledge in psychology, social work, public health, or related behavioral sciences; Previous clinical experience in mental health; Previous clinical trial experience, particularly federally regulated research; Experience in managing data and data analysis (SAS, SPSS, etc); Knowledge of Mood disorders; Experience with MiChart or other electronic health records; Experience with Good Clinical Practice (GCP) and certification.

Monday- Friday 8:30 AM - 5:00 PM, occasional early start at 7:30 AM. This is a term-limited appointment as grant funding is only confirmed available for 1 yr. At the end of the stated term, your appointment will terminate, and you will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct. Note: This position may have the option to renew depending on funding availability.

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