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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.
For more information about the School of Dentistry, please visit our website at: www.dent.umich.edu
The objective of this position is to provide project support and assistance to clinical research at the School of Dentistry’s newly formed Human and Clinical Research Center. The Study Coordinator is responsible for provision of support on the following: regulatory affairs including IRB application submissions and management such as adverse event reporting, protocol deviation reporting, continuing reviews and study terminations. This position reports to and works directly with the Clinical Research Project Manager. Must have a good understanding of GCP, FDA regulations (Code of Federal Regulations), execution of research protocols, subject recruitment, conducting informed consents with study subjects prior to enrollment, collection of project-related specimens and data, recording research procedures and capturing data at designated time points as outlined in protocol. Assists in the reporting of test results and performs data management.
Subject management: review of medical records for study eligibility, obtaining valid consent, scheduling subjects while following protocol timelines, monitoring subjects for side effects, reviewing and reporting of test results, subject education and enrollment, and ORIO/AE tracking and reporting. Assist in developing, designing, and conducting research projects according to protocol with focus on problem-solving and streamlining of processes. Schedule and attend regular study management and initiation meetings with research teams. Assist with managing and accurately reconciling patient incentives via the Human Subject Incentive Program (HSIP). Work with faculty, students and staff in varying dental departments who are conducting human research including clinical.
Regulatory Functions: Performs regulatory function on studies, including adherence to institutional guidelines and fulfillment of Institutional Review Board requirements.
Study Recruitment: Screens and is responsible for the recruitment of subjects, scheduling of clinic visits and the collection, processing and analysis of data. Provides subject education and is responsible for appropriate informed consent documentation process.
Bachelor degree in related field or equivalent experience. At least one year of previous study coordinator experience. All candidates must have excellent organizational and communication skills. Candidate must be able to perform their duties with accuracy, initiative, attention to detail, and have the ability to follow through. Proficient computer skills (i.e. Excel, Word, Google E-mail and Calendar). Excellent ability to multi-task. Excellent attendance record.
SOCRA or ACRP certified. Familiar with University policies and procedures.
This position is located for the School of Dentistry located at 1011 N University Ave.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks will be performed in compliance with the Fair Credit Reporting Act.
MDentistry Mission: advancing health through education, service, research and discovery.
MDentistry Core Values: Compassion, Leadership, Excellence, Responsibility, Trust, Creativity, and Inclusion.
HRSC Guiding Principles: (We CARE2 by providing excellent: Customer Service, Communication, Attention to Detail, Accuracy, Respect, Reliability, Efficiency & Ethics)
The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future. The University of Michigan is committed to foster learning, creativity and productivity, and to support the vigorous exchange of ideas and information, not only in the classroom but in the workplace by: -Creating a work environment in which people treat each other with respect and dignity, regardless of roles, responsibilities or differences. -Providing support, direction and resources enabling us to accomplish the responsibilities of our jobs and to reach the goals that are set for professional and personal growth.
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.