Clinical Research Coord Assoc (with Tech/Asst. underfill)- Term limited
University of Michigan
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 Judith Tam ALK Lung Cancer Research Initiative in the Rogel Cancer Center Department of Internal Medicine Division of Hematology/Oncology is a team science, collaborative program to advance precision medicine for patients with cancer, including ALK+ NSCLC. Through the creation of a diverse multidisciplinary team and broad collaborations we are focused on accelerating progress in discoveries related to the pathogenesis, progression, treatment, and prevention of ALK driven lung cancers. The overarching purpose of this initiative is to foster rapid adoption of key discoveries that directly enhance the quality and length of life of patients.
In this position, you will join a multidisciplinary team focused on researching ALK+ lung cancers of patients presenting at the University of Michigan as well as partnering institutions. Assistance with other cancer site studies may also be included. The ideal candidate would have exceptional interpersonal skills, timely execution, high level data management skills, and high attention to detail. This self-starter would be responsible for helping coordinate the clinical research efforts to fulfill the mission and vision of the ALK Initiative.
This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.
* This is a 2-year-term limited in-person position with the possibility to extend it based on funding and performance.
Why Join Michigan Medicine?
Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.
What Benefits can you Look Forward to?
- Excellent medical, dental and vision coverage effective on your very first day
- 2:1 Match on retirement savings
Responsibilities*
Independent 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
Responsibilities will include, but are not limited to:
- Work closely with the current study team to coordinate and execute aspects of sponsor and/or investigator- initiated clinical trials. These activities include, but are not limited to: screening, consenting, patient communication, data abstraction and entry, attending research meetings, and regulatory management tasks.
- Achieve in-depth understanding of study protocols and objectives to assist with successful implementation of all study procedures.
- Perform screening and coordinate recruitment efforts with various key stakeholders to obtain specimens from both U-M and partnering institutions. This includes attending tumor boards and study meetings.
- Conduct direct and professional interaction with study patients in a clinical, virtual, and phone setting and act as a liaison between patients, investigators, and laboratory team.
- Assist with tissue/sample procurement and transport, patient interaction, patient onboarding, and sample preparation for multi-omic analysis.
- Manage patient research data accurately in an organized and timely manner.
- Register patients and manage clinical study data in OnCore (study setup, subject registration, tracking, and ongoing data entry/QC).
- Administer and maintain a REDCap repository integrating clinical and biospecimen metadata; produce non-PHI exports for analysis and reporting.
- Perform data modeling, analysis, and visualization. Preference with experience using R and/or Python (and SQL where appropriate), with familiarity working in or alongside tools such as SPSS, GraphPad Prism, and Tableau.
- Partner with and provide day-to-day guidance to a software developer to build and maintain a genomic sample database that integrates clinical, sequencing, image, and drug-testing datasets; establish data standards, refresh/update workflows, and automated validation/QC checks.
- Coordinate research activities across faculty investigators and research staff
- Assist with creating study/research related documents, graphics, and presentations for Initiative-wide use.
- Presentation of clinical team recruitment, data, and study status at ALK team meetings.
- Assist with miscellaneous tasks as required by research group including but not limited to visitor itineraries and tours, abstracts, presentations, and publications.
Supervision Received: This position receives direct supervision and reports directly to the ALK Program Manager and Principal Investigator.
Supervision Exercised: None.
Required Qualifications*
CRC Associate:
- Bachelor's Degree in Health Science or an equivalent combination of related education and experience is necessary.
- 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 2 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.
CRC Tech:
- Associate degree in Health Science or an equivalent combination of related education and experience is necessary.
- Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional for qualifying experience prior to applying.) or An advanced degree in a health-related areas such as: Health Sciences, Behavioral Sciences, Public Health, Health Care Administration, Clinical Research Administration, Social Work, Psychology, Epidemiology, Foreign MD. or Minimum 3 years of human subject experience (clinical, lab or health regulations) such as related patient care, related community health and wellness, related clinical information, and research.
CRC Assistant:
- High school diploma or GED is necessary
Desired Qualifications*
CRC Assoc.:
- 4+ years of direct related experience
- Experience performing end-to-end statistical analysis and reporting using modern analytical tools: R and/or Python (e.g., tidyverse/Bioconductor, pandas/statsmodels), SQL, or legacy/commercial platforms such as SPSS/SAS/Stata, and delivering reproducible workflows (notebooks) from raw data through validated results and visualizations.
CRC Tech.:
- Bachelors degree in Health Science or an equivalent combination of related education and experience is desirable.
- An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
CRC Assistant:
- Associate Degree in Health Science or an equivalent combination of related education and experience is desirable. An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
Work Schedule
This is a 2-year term-limited position with the possibility to extend based on funding and performance.
Full-time working M-F in person on-site, with the requirement of schedule flexibility for early morning and evening hours, occasional travel, and rare weekends. This is NOT a remote position.
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.
Underfill Statement
This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.
Additional Information
This is a 2 year term limited position. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.
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.