How to Apply
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.
Job Summary
The Department of Otolaryngology-Head and Neck Surgery is seeking an exceptional clinical study coordinator for a full-time position with knowledge in patient consent, data management and biospecimen collection as well as laboratory procedures including biobanking and analyte processing to work in the Michigan Head and Neck Oncology division. The candidate will work with clinicians, patients and the Michigan Otolaryngology and Translational Oncology (MiOTO) Lab to ensure the success of translational research projects led by the division. As such, exceptional interpersonal and leadership skills are required. Candidate must have expertise in the management of clinical data and experience interacting with patients. Candidate must also have desire to perform basic laboratory procedures related to the clinical studies such as tissue banking, blood processing and DNA/RNA isolation. Job expectations include knowledge and experience in determining suitable clinical workflows, performing procedures with professional judgment, and ability to determine consistency with expected results, assemble, and organize clinical datasets. Candidates with excellent communications skills, time management, organization skills and willingness to work a flexible schedule are desirable.
Through the MiOTO lab, the Head and Neck division plans to employ genomic, proteomic, and bioinformatics approaches on clinical biospecimens to identify novel biomarkers and therapeutic targets. The mission of the division will be to facilitate the discovery, validation, and implementation of candidate target genes/proteins in disease diagnosis, prognosis, and therapy. The lab plans to employ a multi-disciplinary approach, engaging talent from diverse disciplines ranging from medicine, pathology, bioinformatics, biostatistics, engineering, cytogenetics, and molecular therapeutics. This position will focus on ensuring the success and compliance of clinical trials and institutional review board-approved clinical protocols to improve care for Head and Neck Cancer patients.
CRC STATEMENT:
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on the Michigan Medicine CRC Career Ladder is required. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, demonstrate, develop, guide, and support.
Mission Statement
Michigan Medicine improves the health of patients, populations and communities though excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, national 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.
Responsibilities*
Expert level knowledge, skills, and abilities within all 8 competency domains is expected:
- Scientific Concepts and Research Design
- Ethical Participant Safety Considerations
- Investigational Products Development and Regulation
- Clinical Study Operations (GCPs)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication and Teamwork
In this role, and with guidance from faculty and research personnel, day to day responsibilities will include, but are not limited to:
- Screening and enrollment of families for an interventional trial
- Meeting families for study visits,
- Assist with assessments and data collection.
- Conducting telephone visits
- Assist with regulatory as well as DSMB reports.
- Assist in preparing NIH progress reports and other summary materials.
Supervision Received:
This position reports directly to the faculty Principal Investigator.
Required Qualifications*
- Bachelor's degree in Health Science or an equivalent combination of related education and experience.
- Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP)
- Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. Please review SoCRA's Definition of a Clinical Research Professional qualifying experience prior to applying.
- Meticulous attention to detail, strong organizational skills, ability to prioritize and manage time and data are crucial skills for this position.
- Experience with biospecimen banking.
- Experience in regulatory aspects of medical research and policy/procedures in the conduct of clinical trials both at an institutional and federal level.
- Experience with regulatory document development and oversight.
- Must be able to work independently and as a team member.
- Commitment to attend Otolaryngology weekly tumor board meeting from 4:30-6:30.
- Excellent verbal and written communication skills.
- Excellent computer skills, must be proficient in the use of MS Word, Excel and database software.
- Requires flexibility in daily/weekly work schedule to ensure proper protocol adherence, meeting compliance requirements, screening/consenting of new patients, and working with multiple principal investigators.
Desired Qualifications*
- Experience with biospecimen analyte isolation
- Experience using MBECT, eResearch and MiChart
- PEERRS certified
Work Schedule
Requires flexibility in daily/weekly work schedule.
Modes of Work
Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.
Background Screening
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.
Application Deadline
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.
U-M EEO Statement
The University of Michigan is an equal employment opportunity employer.