This position is critical to expanding the translational informatics capabilities of the Institute for Computational Biology (ICB) and supporting/expanding the OnCore Enterprise Clinical Trials management software suite and other corresponding databases being used for human subjects research in the ICB. The responsibilities of this position include management and implementation of computer (hardware and software) and translational informatics solutions for clinical trials and investigator initiated studies. This includes capturing the experimental design, planning workflows, determining end user requirements, and selecting the appropriate translational informatics analysis, storage, data mining, and data archiving tools, and finally the production and dissemination of data and analysis reports.
• Configure and manage databases for clinical trials and investigator-initiated studies using tools such as OnCore Enterprise, LabMatrix, and APEX.
• Design and implement translational informatics workflows via the creation and utilization of SOPs.
• Partner with CWRU hospital affiliates in rolling out an enterprise wide CTMS application, including the development of CRFs, study calendars, and system interfaces (e.g. IRB, DSMB)
• Develop and continually enhance training materials for other clinical research coordinators, CTMS financial analysts, and coverage analysts.
• Serve in a co-leadership role on a multi-disciplinary team addressing the consistent application of data standards to be used in a continually maturing data governenc plan.
• Serve as the in-house expert on FDA regulations (IND, IDE), IRB requirements, GCP standards, and ICH guidelines.
• Provide technical leadership and training in the application of computer hardware, analysis software, and databases for managing projects and disseminating data to scientific collaborators
• Co-lead on the technical writing for program grants, figure generation and publication of manuscripts that utilize the technologies offered by the ICB
• Evaluate the performance of novel technology platforms, as well as track specimen information, experimental and analysis parameters, performance metrics, and, eventually, genomic results in databases.
• Work in conjunction with UTech in the continued development of the SRE integrated computing environment supporting Microsoft,and UNIX/Linux operating systems, and software applications supporting translational informatics research.
• Over time in the position, and working with other members of the translational informatics team, understand, manage and archive large data sets such as those in biorepositories and EHRs, and develop, refine, and improve tools for interpretation and analysis of these large data sets.
Perform other duties as assigned.
Department: Frequent contact with ICB Translational Informatics staff and ICB Faculty
University: Frequent contact with other CWRU collaborating Departments including other basic and clinical science departments and UTech
External: Frequent contact with technology vendors and other collaborating institutions
Students: Some contact with students
Experience: Minimum of 5 years’ experience working at the Ph.D. level
Education/Licensing: Ph.D. required in Biology, BioInformatics, or a related biological science field
REQUIRED KNOWLEDGE, SKILLS and ABILITIES
Demonstrated expertise in clinical trials management and the utilization of clinical trials management software such as OnCore Enterprise.
Strong knowledge of the regulatory environment governing clinical trials and investigator initiated studies.
Professional and effective oral and written communication skills; and good interpersonal skills with the ability to work and communicate with various individuals within and external to the University. Must be able to clearly relay information to the PI and other researchers and prepare written documents for grant submissions, manuscripts, publications, etc. as needed.
Strong organization skills; ability to multi-task, prioritize and meet deadlines. Must demonstrate attention to detail and accuracy, time management skills, and follow-through.
Effective management skills; ability to lead, train, work with, and elicit cooperation from team members and staff.
Ability to work effectively independently and collaboratively within a team. Must be highly motivated, responsible, dependable and a self-starter. Must demonstrate a strong desire to learn and to advance research.
Effective problem-solving skills; must demonstrate excellent analytical skills, sound judgment and good decision-making.
Must demonstrate flexibility and ability to work under pressure; must be able and willing to conform to shifting priorities, demands and timeline.
Willingness to follow analytical data protocols and provide suggestions to the PI for improvement.
Proficiency in database management software packages.
Excellent overall computer skills; must demonstrate proficiency in Microsoft Office and data management.
Standard dry lab research environment (office setting). No wet lab work required.
Qualified candidates should submit their cv to firstname.lastname@example.org
Case Western Reserve University is an Equal Opportunity Employer encouraging excellence through diversity. Qualified woman and minority candidates are encouraged to apply.
Case Western Reserve University provides reasonable accommodations to applicants with disabilities. Applicants requiring a reasonable accommodation for any part of the application and hiring process should contact the Office of Inclusion, Diversity and Equal Opportunity at 216-368-8877 to request a reasonable accommodation. Determinations as to granting reasonable accommodations for any applicant will be made on a case-by-case basis.