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 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 globally. Specifically, we are looking for an individual to function as the lead coordinator for a large longitudinal registry that is being established. The ideal candidate would have in depth experience with AI, registry-based research, and biostatistics along with exceptional interpersonal skills, timely execution, 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 is a 2-year term-limited position with the possibility of renewing for an additional year(s) based on funding and performance.
Expert level knowledge, skills, and abilities within all 8 competency domains is expected
1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. 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 studies. These activities include, but are not limited to: study startup, database management, 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.
- Take an active role in the establishment and best research practices for a large active registry study.
- Perform screening and coordinate recruitment efforts with various key stakeholders to obtain specimens from both U-M and partnering institutions. This includes attending relevant study meetings.
- Conduct direct and professional interaction with study patients in a clinical, virtual, and phone setting and act as a liaison between patients, database tech support team, 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. Responsibilities may include:
- OnCore patient and clinical study registration and data management
- Investigate, create, code, and manage REDCap or other registry database housing for clinical data, sample information, and execute non-PHI data transfer into determined shared data space.
- Conduct data modeling exercises using REDCap (or other database), statistical software including SPSS, GraphPad Prism, Tableau.
- Create, model, and update genomic sample database with multiple clinical/sequencing/drug testing overlapping variables
- Create and prepare data collection statistical reports and analytical summaries for distribution to study research team for review and analysis.
- Coordinate research related activities across faculty investigators, laboratory staff, and research staff including meeting coordination.
- 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 and advisory board meetings.
- Assist with miscellaneous tasks as required by research group including but not limited to other study backup, visitor itineraries and tours, abstracts, presentations, and publications.
Supervision Received: This position receives direct supervision and reports directly to ALK Program Manager, Clinical Lead, and Principal Investigator
Supervision Exercised: None
- 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 prior to applying.)
- Minimum 2 years 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.)
- Knowledge and experience in biostatistics.
- Proficient working in AI
- 4+ years experience
- Bachelors of Scientific Nursing with clinical research experience
- Experience with large registry studies
- Experience with AI EMR integration
- Data science certification
- CITI Human Subjects and GCP certification
This is an on-site, full-time term-limited position requiring flexibility for early mornings and evenings due to research sample collection and meetings. This is NOT a remote or set 9am-5pm position. Occasional travel and rare weekend work may be needed. An 80% position may be considered for the right candidate.
This is a 2-year term-limited appointment. 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.
Michi
