A cover letter with references and resume are required for consideration of this position. The cover letter should address your specific interest and a paragraph discussion how your skills and attitude would be a good match for this position.
The Neurology Clinical Trials Organization (NeCTO) is seeking an experienced, positive, highly motivated, organized, autonomous person with excellent multi-tasking ability, supervisory and record-keeping skills to join our growing research team. The characteristic duties and responsibilities of this position involve patient/family interaction along with supervision of other study personnel and may evolve over time to match changing needs and priorities within NeCTO.
The NeCTO program provides leading-edge clinical research on a variety of diseases in Neurology. The Clinical Research Project Manager is a specialized research professional working with and under the direction of one or more Principal Investigators (PI). While the PI is primarily responsible for the overall design, conduct, and management of one or more clinical trials, the Clinical Research Project Manager facilitates and coordinates the daily clinical research activities and plays a critical role in the recruitment, retention, and conduct of the studies assigned. By performing these duties, the Clinical Research Project Manager works with the PI, co-investigators, coordinators, department, sponsor, and institution to support and provide oversight on the recruitment of study subjects, scheduling of tests, follow-up appointments, and retention of families as well as other aspects critical to effective conduct of clinical research.
This position will also take on the responsibilities of Portfolio Manager for the Neurosciences and Sensory Clinical Trial Support Unit (NSS CTSU). The Portfolio Manager is responsible for working with the NSS CTSU Administrator, the CTSU Finance Team, PIs, study teams, Sponsors, and the Office of Research to facilitate the timely and efficient launch of new studies, and to maintain current studies in OnCore.
NeCTO Clinical Research Project Management (75%)
Provide guidance and supervision to study coordinators and research assistants.
Assist PI with design, development, and execution of clinical trials and other clinical research studies.
Manage the day-to-day study subject experience and laboratory data generated by studies, including:
Recruitment across several clinical sites, obtaining consent, and retention of participants;
Scheduling study visits
Direct interaction in a clinic setting with patients including administration of survey instruments and coordination of neuropsychometric testing;
Oversee data collection;
Assist in reporting results;
Monitor and disperse subject fee payments;
Ensure a positive experience for subjects and their families.
Work with Neurology Clinical Trial Operation (NeCTO) Manager to ensure key personnel meet training requirements in accordance with the Neuroscience and Sensory CTSU, NeCTO, department, and federal regulations.
Manage workload, effort, and meetings with fellow team members.
Maintain detailed knowledge of all protocols in the designated area and all associated assessments and procedures
Track equipment delivery and supplies.
Manage various aspects of clinical research billing.
Assist with management of space and equipment used for program research.
Assist PI with data safety monitoring compliance and NIH reporting.
Regulatory management including IRB submissions in eresearch, billing calendars, study budgets, collecting regulatory documents, execution of study protocol and conducting monitoring visits.
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 multiple ongoing studies.
Attend investigator meetings as part of the study team for industry sponsored study initiation. This may include travel to sponsor locations for training.
Participate in recruitment strategic planning meetings, and all staff meetings.
Work collaboratively with team members, including training, mentoring, and cross-covering for other studies when needed.
Other duties as assigned.
NSS CTSU Portfolio Management (25%)
Submit and/or review new study Intake Forms.
Enter new studies into the OnCore system.
Work with study teams and Sponsors to obtain required study documentation and submit for feasibility review.
Guide processes with contracting, IRB, and other support units to facilitate timely launch of new clinical research studies.
Meet with study teams and support units after feasibility approval to ensure successful launch of new studies.
Work with CTSU Finance Team and OSRP to facilitate study agreements, budgets, and contracts.
Work with CRAO to ensure timely review and completion of billing calendars and calendar amendments.
Oversee study status and enrollment progress in OnCore
Strong ability to work independently, exercising good judgment, with minimal supervision
Excellent problem-solving skills
Solid record of mentoring and training experience
Demonstrated understanding of GCP, ICH, HIPAA, and FDA regulations
Professional demeanor and excellent interpersonal and communication skills
Confident and highly motivated with excellent multi-tasking ability and record-keeping skills
Ability to respect and protect confidential information
Accurate and efficient
Ability to adhere to established timelines to accomplish tasks
Demonstrated ability to learn and use new skills quickly and effectively
Outstanding organizational skills with meticulous attention to detail
Positive attitude and willingness to help
Ability to be flexible and focused in a sometimes fast-paced, ever-changing environment
Proficiency in the use of computers and software including Microsoft Office products (Word, Excel, PowerPoint, Outlook)
Comfortable interacting with patients suffering from a variety of neurological disorders, including cognitive and/or physical disability
Master’s degree in clinical trials or a health science discipline
Experience in the creation and management of research study budgets
A working knowledge of medical terminology and assessment of laboratory values.
Experience with database development and database management (including survey development using REDCap, Velos, etc.)
Experience working with MiChart, OnCore, and eResearch
GCP certified; CITI, PEERRS
Prior health care and/or research experience
Shift/Hours: Primarily M-F days, however variability may be required by some projects including early mornings, evenings, and weekends.
NeCTO supports clinical research in neurological diseases such as Stroke, Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease, Epilepsy, Multiple sclerosis, and other neurological conditions. We are looking for a self-motivated leader to join our team that will take on research staff and research project supervision, as well as to be the Portfolio Manager for Neurology in the Neurosciences and Sensory CTSU.
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.
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.
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: 179160
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.