"Clinical Research Coord Assoc (with Tech/Asst. underfill)- Term limited"

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 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.

Independent 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 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.

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 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 SoCRA's 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

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.

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.

This position may be underfilled at a lower classification depending on the qualifications of the selected candidate.