Join Our Clinical Trials Team

Job Description:
Clinical Data Assistants provide expertise in data management to support all phases of sponsor-developed clinical studies including managing all data management tasks of complex and/or large studies from start-up through database closure and archival. They produce high quality data for analysis and potential regulatory submissions. Clinical Data Assistants are the point of contact for day-to-day study activities, providing hands-on support to study teams and collaborating with external vendors for multiple clinical trials. 

Education/Experience:
Entry positions require high school diploma or equivalent.  

Experience in clinical research and/or clinical setting and medical terminology proficiency preferred for both entry and intermediate positions.

Job Description:
Clinical Research Coordinators perform duties related to the coordination of clinical studies. They coordinate studies from start-up through closeout. Clinical Research Coordinators serve as the primary contact for research participants, sponsors, and regulatory agencies. They coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions while maintaining contact with study participants.

Education/Experience:

Entry positions require bachelor’s degree.

Intermediate positions require bachelor’s degree and 2 years of related experience.

Senior positions require bachelor’s degree and 5 years of related experience.

Job Description:
Quality Assurance Monitors are responsible for ongoing monitoring of clinical trial data for local, investigator-initiated clinical trials, concentrating on data accuracy and completeness, protocol adherence, and toxicity and response review. Their work focuses on Phase I, I/II, and II protocols, and they interact directly with each study Principal Investigator. Their ongoing review includes study participant registration, data submission and protocol compliance, toxicity review, adverse event monitoring, and response review. They report all findings to the Lurie Cancer Center Data Safety and Monitoring Committees.

This role supports the implementation of the Quality Assurance strategy to facilitate specific tasks in compliance with appropriate regulations, guidance documents, company policies, and departmental standard operating procedures (SOPs). This role involves engaging and collaborating with cross-functional internal teams to evaluate study-related processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company SOPs as appropriate.

Education/Experience:
Entry positions require bachelor’s degree in an allied medical profession or other health sciences field or the equivalent combination of education and experience from which comparable skills can be acquired. Entry positions also require 1-2 years prior experience coordinating, data entry, or monitoring therapeutic clinical trials.

Intermediate and senior positions require master’s degree or other graduate-level degree or the equivalent combination of education, training and experience from which comparable skills can be acquired. Intermediate positions require 3-5 years of experience in clinical trial development while senior positions require 7+ years of experience in clinical trial development.

Job Description:
Regulatory Coordinators manage and guide the review and approval process of all research activities associated with clinical research studies involving human subjects ensuring the protection of their safety, rights, and welfare. They interpret and apply rules and regulations (NU, local, state, federal, industry, sponsor, etc.) and recommend and guide principal investigators and research staff in the creation, submission, documenting, reporting, etc. of study activities ensuring appropriate compliance. This role provides regulatory support for multiple clinical research studies, which may involve multi-centered cooperative group studies, single site studies, intergroup studies, industry studies, and investigator initiated studies.

Education/Experience:
Entry, intermediate and senior positions require bachelor's degree in related field or the appropriate combination of education and experience. Demonstration of regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice guidelines is required. Intermediate positions require 1-2 years of work experience in a regulatory and/or medical research environment, while senior positions require 3 years of work experience in a regulatory and/or medical research environment.

Job Description:
Clinical Operations Managers oversee all activities associated with highly-complex biomedical and/or social-behavioral research studies, including investigator-initiated trials, National Cooperative Group Trials with multiple affiliate institutions, and global sponsored trials. They are responsible for planning and executing clinical trial programs for assigned disease teams with a focus on FDA registered trials. Clinical Operations Managers serve as subject matter experts with internal and external contacts at various management levels concerning clinical operations of trial portfolios for assigned disease teams. They regularly interact with executive management on workflow management that impacts larger organizational goals. They provide technical expertise to staff for development of clinical trial documents and records and trial conduct.

Education/Experience:
This position requires bachelor’s degree or higher in a major such as social or health science or related field and 3-5 years of research study experience. Supervisory or project management experience is also required for this position.