Research - Laboratory/Non-Laboratory, Staff/Administrative
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 Neurology Clinical Trials Organization (NeCTO) is seeking an experienced, positive, highly motivated, organized, autonomous individual with excellent communication and multi-tasking skills to join our growing research team. The Clinical Research Coordinator will work with principal investigators and other research team members to accurately and efficiently carry out a range of tasks associated with a variety of neurological clinical research studies. The characteristic duties and responsibilities of this position may evolve over time to match changing needs and priorities.
The Clinical Research Coordinator position’s responsibilities include, but are not limited to the following:
Screen, recruit, provide informed consent, and enroll participants according to protocol for clinical studies.
Schedule and coordinate participants study visits or work with Neurology scheduler to set-up study visits.
Directly interact with subjects in a clinic setting including subject interviews, administering survey instruments, etc. May include neuro-psychometric testing depending upon neurological condition under study.
Track and monitor participants’ condition and test results during the course of clinical studies. Relay relevant results to the clinical team.
Collect and record participants study-related data.
Collect, process, label, store, and ship bio-specimens for clinical studies.
Ensure all study related documentation is completed accurately with quality and in a timely fashion per sponsor requirements. May require data entry into both electronic and paper case report forms.
Manage regulatory requirements including IRB submissions in eResearch Regulatory Management system, collection of essential regulatory documents, execution of study protocol, and preparation for sponsor monitoring visits.
Perform medical chart reviews.
Review billing calendars and study budgets to ensure appropriate care designations and costs for clinical studies.
Work with administrative staff to ensure appropriate billing for study-related care.
Assist in the promotion of educational programming and events to enhance awareness of neurologic diseases.
Design source documents, recruitment materials, and other relevant study documents for clinical studies.
Participate in recruitment strategy meetings to enhance subject awareness of studies and boost subject participation.
Attend investigator meetings as a study team member.
Attend training at sponsor site(s) or during investigator meetings.
Participate in NeCTO staff meetings.
Work collaboratively with NeCTO team members, including training, mentoring, and cross-covering for other studies when needed.
Assist research team in generation of presentations, abstracts, posters and manuscripts.
Perform general office and administrative duties related to clinical studies.
Other duties deemed necessary to maintain the smooth operation of Neurology clinical studies.
High school diploma, college degree, or equivalent experience in a health science discipline.
Professional demeanor and excellent interpersonal and communication skills.
Experience with Microsoft Office products (i.e. Microsoft Word, Excel, and Power Point)
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills.
Outstanding organizational skills with meticulous attention to detail.
Strong ability to work independently, exercising good judgement, with minimal supervision.
Ability to function with diverse teams of people in a diplomatic, collaborative, and effective manner.
Strong problem-solving skills.
Ability to adhere to established timelines to accomplish tasks.
Demonstrated ability to learn and use new skills quickly and effectively.
Able to maintain data confidentiality and participant/subject/patient privacy.
Excellent attendance record and strong work ethic.
Understanding of ICH-GCP guidelines, OHRP, HIPAA, and FDA regulations
Bachelor’s or Master’s degree in a health science discipline preferred.
At least 2 years’ research experience with federally-sponsored and/or industry-sponsored clinical studies, including direct interaction with patients in a patient care setting or outpatient clinic.
Strong experience using e-Research Regulatory Management system, OnCore Clinical Trial Management System, and MiChart.
Experience with Electronic Data Entry/Capture (EDC).
A working knowledge of medical terminology and assessment of laboratory values.
ACRP or SOCRA certified.
ICH-GCP certified through CITI, HIPAA, and PEERRS training complete and up-to-date.
Experience in database development and management (including developing surveys using RedCap, Velos, etc.).
Possible physical requirements include, but are not limited to: occasional lifting and carrying of objects weighing 5-30 lbs.; able to observe and verbally exchange information with study participants and caregivers; repetitive use of upper and lower extremities; kneeling; walking; standing; leaning over for extended periods; squatting; climbing, or reaching; pushing or pulling heavy equipment; moving of study binders; and sitting for extended periods of time. There may also be exposure risk to potentially infectious blood and/or body fluids, fumes or chemicals.
The Department of Neurology offers the following additional amenities:
Professional growth and development opportunities.
An experienced, knowledgeable, and friendly team of Study Coordination professionals to assist in training.
Flexible work schedules (primarily consisting of a 5-day work week, flexing in mornings or afternoons); however, variability may be required by some projects including early mornings, evenings, and weekends.
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.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 189190
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.