The Trial Management Associate utilizes multiple quantitative and qualitative datasets from a variety of sources and interprets results using various techniques, ranging from simple data aggregation via statistical analysis to complex data mining. Assists in the design, development and implementation of business solutions partnering with clients to identify analytical requirements. Compiles reports, charts, and tables based on established statistical methods.
The Trial Management Associate manages daily operations of a biomedical &/or social-behavioral research study involving multidisciplinary teams of colleagues, sponsors and other external project stakeholders. Assists in the design development and implementation of business solutions partnering with clients to identify analytical requirements. Monitors study performance, analyzes and review results and supervises development and implementation of new protocols. Ensures that all study activities are completed by strictly following Good Clinical Practices (GCP) and all current local, state and federal laws, regulations, guidance, policy and procedure developed by the Northwestern University Institutional Review Board IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). Assist with Study Start-UP and Multi-Site Management as needed.
Partners with clients to define requirements based on business objectives.
Leads execution & control of research data bases for trial endpoints.
Ensures completion of study activities per protocol including recruitment.
Develops new and/or revised research methodologies.
Develop standardized templates, policies, and procedures for internal and external reporting.
Comply with current local, state and federal regulatory guidelines, requirements, laws and research protocols completion in a timely manner.
Designs and prepares documentation for qualitative and quantitative data analysis.
Oversees and manages collection, maintenance, analysis and evaluation of data to be used in grant submissions, presentations and publications.
Ensures information is entered correctly into databases.
Assists PI in reviewing, analyzing, interpreting, summarizing, formatting, editing, preparing tables, charts, graphs, progress and final reports, etc.
Coordinates between sponsoring, collaborating and affiliate agencies.
Completes a variety of statistical analyses using appropriate data and software.
Merges data from multiple sources in preparation for analysis.
Interprets results of analyses for use in reports and presentations.
Reviews case report forms submitted for accuracy, protocol compliance and completeness. If errors exist, generates queries and submits them to the coordinator/data manager associated with the protocol.
Completes data cleaning and organizes data files for analysis.
Reviews data and identifies quality issues.
Assists in monitoring and auditing of data for clinical research trials.
Creates timeliness reports and data analytics by disease teams.
Performs other duties as assigned.
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree; OR appropriate combination of education and experience.
Microsoft Office (Word, Excel, PowerPoint, Access, Outlook)
CCRC, CCRP, CCRA
21 CFR Part 11
Data warehouse design/develop
Database design/data structure
Process improvement, optimization.
Collaboration and teamwork
Minimum Competencies: (Skills, knowledge, and abilities.)
Computer literate in Microsoft Office, Internet, and database use.
Ability to establish and maintain effective working relationships with physicians, affiliate centers and coworkers.
Preferred Qualifications: (Education and experience)
Strong regulatory background as demonstrated by knowledge of the Code of Federal Regulations and Good Clinical Practice guidelines.
2 years prior experience coordinating or monitoring therapeutic clinical trials.
2 years prior experience in clinical trial development.
Experience with data completion or familiarity with data form completion guidelines.
Experience in staff education and training activities.
Prior experience in a cancer research setting preferred.
Preferred Competencies: (Skills, knowledge, and abilities)
Knowledge of data management and case report form development preferred.
Experience collaborating with multiple sites in clinical research.
Understanding of the clinical trial start-up process.
Familiarity with reviewing Serious Adverse Events (SAEs), CDAs and other clinical research specific documents.
Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Hiring is contingent upon eligibility to work in the United States.
Internal Number: 36171
About Northwestern University
Northwestern University is a major private research university with 12 academic divisions located on three campuses in Evanston, Chicago, and Education City in Doha, Qatar. We have approximately 2,500 full-time faculty members, 17,000 graduate and undergraduate students, and over 5,700 full and part-time staff. Northwestern University combines innovative teaching and pioneering research in a highly collaborative environment. It provides students and faculty exceptional opportunities for intellectual, personal and professional growth.