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) is responsible for managing clinical trial performance and ensuring the conduct of each trial is congruent with the philosophy and mission of the Program for Clinical Research in Dermatology (PCRiD). The CRC plans, coordinates, evaluates, and manages the care of both the participants and the data for their assigned research projects. The CRC follows study-specific protocol guidelines and communicates and interacts with investigators, clinic staff, sponsoring agencies, and others to effectively coordinate research activities. All duties carried out by the CRC are done so in accordance with the University of Michigan policies and SOPs, as well as all applicable local, state, and federal regulations.
Duties include, but are not limited to the following:
Coordinate clinical research studies conducted by Principal Investigators including, but not limited to grant-funded research, externally sponsored clinical research, and investigator-initiated clinical research.
Work closely with the Principal Investigator and PCRiD staff to coordinator all aspects of conducting clinical trials including: screening, enrollment, and study subject visits.
In conjunction with the Principal Investigator and Clinical Research Manager, determines the appropriate patient population, recruits and maintains the target number of subjects for trial participation.
Enters data into the study’s electronic data capture system and responds to queries in a timely manner.
Assists the Principal Investigator with reporting of unanticipated problems (ORIOs, deviations, adverse events, SAEs).
Serves as the primary regulatory contact for assigned protocols.
Guides and coordinators all clinical trials-related submissions, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-outs, etc.)
Submits all necessary documents to the IRB and other internal/external regulatory and oversight groups.
Upkeep of study staff training and delegation logs
Maintenance of updated site staff CV’s, licenses, etc.
Process laboratory samples
Prepare laboratory kits
Coordination with other study and laboratory staff
Other duties as assigned or required by the research project
Stock and maintain exams rooms
Other administrative duties as assigned
Associates degree or combination of education and experience
3-5 years of clinical research
Excellent interpersonal and organizational skills.
Outstanding computer skills.
Ability to demonstrate full working knowledge of standard concepts, practices, procedures, and policies in clinical research with the ability to use them in varied situations.
Ability to work collaboratively and independently to improve the operations by identifying issues and offering ideas.
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 remain calm in stressful situations.
Eager to learn new skills and develop within clinical research
Familiarity with MiChart or EPIC, as well as with scheduling programs.
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: 189066
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.