A cover letter is required for consideration for this position and should be attached as the first page of your CV, along with three references. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
Highly motivated individual sought for a clinical research coordinator healthcare position within the Department of Emergency Medicine, at Michigan Medicine. The candidate will serve as a clinical research coordinator for multiple studies and will work closely with Division of Critical Care faculty.
Coordinate daily study operations. Independently, manage large amounts of data for data entry, data extraction, and data-quality checks; and maintenance of large research databases. Assist with submission and approval of IRB applications and actively manage IRB applications, amendments, etc... Assist with data analyses and prepare reports of completed projects for publications in technical journals, applied or theoretical research activities, etc... Work with faculty and staff to efficiently manage multiple data capturing systems. Create and organize data into easily manageable spreadsheets, tables and graphs for periodic presentations to study staff and investigators, and for regulatory bodies including NIH and IRBMED. Works closely with research team members and study associates as needed. May act as liaison with other departments, divisions and organizations.
May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluates results. Formulates research methods and suggests options for improving quality, identifies potential problems, recommends and implements solutions. Consults with users to refine or adapt methodologies to fit research requirements; collaborates in development of new techniques and instruments. Develops protocol and criteria. Gathers data, supervises data collection and verification, and has oversight for literature reviews. Performs data analysis and interprets results.
Will be responsible for patient recruitment, including pre-screening patient medical records, calling or interviewing potential subjects face-to-face to confirm eligibility, and consenting for studies after exercising professional judgment on whether subjects meet inclusion and exclusion criteria, making sure that they both understand and are capable of adhering to study requirements. Schedule and oversee subject visits, which may involve the administration of surveys in person or by telephone, obtaining of medical histories, and collection of biological specimens. Responsibility for the management of all subject records and documentation and the maintenance of a secure database created to house this information. Monitoring subjects for safety and compliance with protocols and for the analysis of patient data. Effectively communicate with the IRB for clinical study approvals, amendments, and continuations. Effectively update granting agencies on annual progress of research projects. Will support a busy and growing clinical and human studies research program. Coordinate multiple studies. including budget preparation, IRB application and reporting of adverse events, review medical records, recruit patients, screen patients for eligibility, follow patients in the study, monitor side effects, review test results, enter data into case record forms (hard copy and electronic). May reconcile study expenses, communicate and negotiate with study sponsor, IRB, investigational pharmacy, patients, referring doctors, CTSUs and separate units such as the Michigan Clinical Research Unit (MCRU) team.
This positions will assist with studies within the Acute, Critical Care, Surgery & Transplant Clinical Trials Support Unit (ACCST CTSU) and would require covering 2 evening shifts per week (2pm-10pm), as well as covering (1) weekend per month.
This position will also be assisting with coordination of research meetings and additional research initiatives.
Additional work related tasks, not specifically outlined above, will be required of the candidate. Cross training with other staff will also be required.
Bachelor's degree in natural sciences, human sciences, social science, biostatistics, public health field, or related field, with 1-3 years of experience. Minimum of 1 year of experience in human studies research including recruitment, IRB applications, and/or budget preparation is necessary. Essential to be proficient in computer programs including word processing and spreadsheets. Good interpersonal communication skills. Individual must be organized, attentive to detail, motivated to learn, possess time management skills, and be capable of functioning independently.
Familiarity with MiChart. Knowledge of regulatory requirements. Experience with clinical data capturing systems or similar databases. Past experience with confidential and sensitive health information for data entry and management. Statistical methods background and responsibilities in previous employment.
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.
For questions, please contact: Stephanie L. Laurinec Michigan Medicine-Department of Emergency Medicine Email: firstname.lastname@example.org
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. 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: 161274
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.