Clinical Research Coordinator Healthcare - Term Limited
University of Michigan - Ann Arbor
Application
Details
Posted: 13-May-22
Location: Ann Arbor, Michigan
Salary: Open
Internal Number: 216236
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.
We are seeking a highly motivated research coordinator to join our team. This person will plan, organize and coordinate a multi-site federally funded clinical trial in the Division of Pain Research in Anesthesiology. This is a fast-paced clinical environment with a dynamic team. Emphasis is placed on maintaining a positive work environment, fostering comradery and encouraging professional development.
Our mission is to improve the quality of life of people with pain. Achieving personalized pain management will transform care, while dedication to our guiding principles enriches the lives of our team members and those in the community.
Study Oversight (80%):
Oversee and complete all aspects of clinical trial coordination including: identifying and screening potential subjects, consenting and enrolling subjects, collecting and managing biospecimens. Coordinate participant study visits across multiple departments
Collect specimens and processing. Ensure integrity of specimens (collection, processing, shipping, storing, labeling, tracking, etc.)
Serve as a resource and train research staff in performing specified job duties as specified by the program manager
Develop improved work flows and source documents as needed. Maintain source documents for accurate tracking, collection and recording of data
Oversee data and biospecimens transfers between institutions per protocol
Oversee recruitment activities and personnel at several local off-site locations
Act as a liason between investigators, research teams, sponsors, other universities, consortiums, and other internal/external stakeholders
Utilizes critical thinking skills to recognize and solve patient/participant problems
Achieve proficiency in working with REDCap and Qualtrics. Be able to run reports, enter participant data into CRFs, distribute surveys in a timely manner and correctly.
Keep study correspondences and documents organized. Ensure changes are implemented in study procedures and workflows as needed
Assist in preparation of posters and slide material for data presentation.
Ensure adherence to project timeline and create reports on project milestones
Regulatory (10%):
Ability to identify and expeditiously report Adverse Events (AEs) and Serious Adverse Events (SAEs)
Coordinate and create reports to the study sponsor, DSMB, IRB and other oversight committees
Conduct data cleaning as specified in the study protocol and with clinical monitoring of studies
Attain an in-depth understanding of the study/grant protocols and objectives to assist with their successful implementation. Also ensure that study team is adhering to protocol and study procedures
General (10%):
Staff members are expected to work 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
Other tasks as defined
Bachelor's Degree or higher preferably in health science or health related field.
At least 3 years of experience working on moderate to complex clinical trials with direct patient contact.
Understanding of some medical terminology
Demonstrates: an understanding of clinical research; an understanding of compliance issues related to human subjects research, and knowledge and application of the Code of Federal Regulations (CFR) and Good Clinical Practice (GCP)
Ability to organize and manage multiple tasks simultaneously, as well as prioritize and exercise good judgment. This position requires the highest levels of integrity, attention to detail, resourcefulness and time management skills
Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner
Ability to provide a high level of customer service to patients, visitors, staff, and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem-solving
Ability to anticipate and plan for potential problems and formulate pragmatic solutions
Ability to remain calm in stressful situations
Eager to learn new skills and develop competencies within clinical research
Experience with project management
Experience with investigator-initiated and federally sponsored clinical trials
Knowledge of UMHS policies and practice
Familiarity with OnCore, Epic, MiChart, REDCap, Qualtrics and eResearch applications
PEERRS, CITI, or NIH Protection of Human Subjects Training Certification
The work schedule for this position consists of regular business hours, M-F from 8-4:00pm.
This position is a 2 year term limited appointment with patential for extension based on grant funding and performance. At the end of the stated term, the appointment my terminate and will not be eligible for Reduction in Force (RIF) benefits.
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.
The University of Michigan is an equal opportunity/affirmative action employer.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine. This includes those working remotely. More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.
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.