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.
The Clinical Research Coordinator (CRC) will provide a valuable service assisting faculty with study coordination of clinical trials. The CRC will be available to assist study teams with study coordinator activities such as screening, consenting, and enrolling subjects; collection and management of patient and laboratory data; IRB application preparation, and regulatory management. Additionally, the CRC will manage audits and monitoring visits, as well as other duties as needed. The position could include travel to off-site locations and some flexibility in schedule due to meetings and scheduled study activities.
Assist study teams with aspects of clinical trial coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collections, processing, shipping/packing, storing, labeling, tracking, etc.).
Perform data management and results reporting, such as entering information into databases and Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.
Act as liaison between study team and sponsors, IRB, federal, state and university officials and other regulatory agencies, including clinicaltrials.gov, to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitoring visits.
Prepare and organize space for study-related materials and equipment.
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 maintaining the strictest of confidentiality at all times.
Bachelor’s degree in a science or health-related field, or equivalent education and experience. Minimum of 3 years of experience as a study coordinator.
ACRP/SoCRA certification. Experience with the IRB application process. Proficient in sample collections/handling. Demonstrated understanding of clinical research; including compliance
issues related to human subjects research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and Federal regulations.
Excellent interpersonal, oral and written communication skills with exceptional attention to detail, including interaction with patient subjects. Proficient computer skills including Microsoft
software applications. Must be proficient in Microsoft Excel. Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment.
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner. Excellent attention to detail.
Excellent attendance record.
Knowledge of University policies and procedures. Familiarity with MiChart. Familiarity with eResearch applications. Familiarity with MiDent. PEERS or NIH Protection of Human Subjects Training Certification. Knowledge of medical and dental terminology. Experience working in a health care setting.
This position is a 4 year term-limited position with an end date of 7/31/2024. The first 3 years will be at 100% FTE or 40 hours per week with the fourth and final year being at 50% FTE or 20 hours per week
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: advancing health through education, service, research and discovery.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 189713
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.