This position is responsible for data management and clinical trials coordination in support of projects in the Clinical Trials Statistical and Data Management Center (CTSDMC). Responsibilities include assisting in the development of clinical trial protocols, manuals, and data management and safety management plans and identifying appropriate resources for research projects; designing forms to collect and track study data, subjects, drugs, biological specimens and/or procedures; assisting in the design of database management system applications and developing specifications for data processing; performing all data processing tasks including data cleaning, manipulating and importing/exporting. This position will work closely with external research partners and other CTSDMC team members to determine requirements and create comprehensive solutions for data collection, verification and validation. As a member of the CTSDMC Data Management team, this position will work closely with the IT and Data Management teams to develop the databases and data entry systems. This position is responsible for mission-critical research applications and sensitive data, so attention to detail and quality are critical.
Key Areas of Responsibilities
Protocol Development/Management and Study Responsibilities
Consult with researchers to assist in protocol development and developing data management and safety management plans and provide input into descriptions of complex research procedures. Assist in identifying resources that are appropriate for each research project.
Meet regularly with CTSDMC programming and data management staff to discuss specified trial design and to develop associated database design and data entry systems.
Design forms to facilitate the collection and tracking of data, subjects, study drugs, biological specimens, and study procedures.
Develop CTSDMC procedures for various components of each trial's protocol and data management plan; document procedures for use in manuals, reports, or meetings.
Assist in the design, development, execution administration and maintenance of protocols and clinical studies. Assist in study design and protocol development and provide input into descriptions of complex research procedures. Oversee CRF development. Review query reports. Resolve all monitoring visit issues. Perform and monitor randomizations. Develop complex study materials. Serve as liaison to local health care practitioners, agencies, and sponsors.
Research/Clinical Activities; Subject Recruitment and Enrollment
Develop forms and tracking methods to monitor screening, recruitment, enrollment and obtaining informed consent for multicenter clinical trials.
Develop and test online enrollment, randomization and follow-up procedures for study participation.
Assist in the preparation of research papers and manuscripts for publication and presentation at conferences and workshops; assist in writing research progress reports, articles, and other documents, including summarizing recruitment and data collection results, adverse experiences, and safety issues.
Participate in meetings and training sessions for participating clinical center staff for designated trials.
Prepare training materials and make presentations to clinical center staff in how to perform data processing tasks.
Data Collection and Monitoring
Assist in the design of database management system applications and develop specifications for data processing such as data entry, verification and validation of data, error identification, and data edits.
Design and coordinate field tests for data collection forms and assist in design of certification procedures for participating clinical center staffs for designated trials
Perform all data processing tasks, such as entering data, verifying data, identifying problem data, generating queries to clinical staff, editing data, preparing data for statistical analysis, tracking subject recruitment and accrual, and tracking protocol violations.
Coordinate the processing of data from participating clinical centers; coordinate the processing of laboratory data from participating laboratories; coordinate central data entry and develop associated procedures.
Assist in the development of error resolution processes at participating clinical centers for designated clinical trials and the CTSDMC documentation of the error resolution process. Participate in the design, development and testing of clinical research trials data systems. Validate data, query resolution and make recommendations for resolution. Revise and implement change in data collection.
Regulatory Guidelines and Documents
Develop procedures for on-site data audits at participating clinical centers; participate in on-site data audits at participating clinical centers; design and generate reports for use in data audits; summarize results of audits and write reports for the CTSDMC and funding agencies. Follow-up with centers to insure corrective action post-audit has been completed. Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions. Perform on-site audits of research and clinical data. Monitor compliance of regulatory guidelines and proper maintenance of documents. May recommend corrective action for reportable events. May communicate with IRB staff and investigators.
Participate in the team approach to development of general goals for CTSDMC and in the planning of procedures for project completion, including monitoring the progress of designated trials, identifying potential problems, and recommending action.
For a full job description, please send an e-mail to the contact listed below.
Requires the academic knowledge of a scientific field including advanced study or demonstrated capacity for scientific research that is generally associated with a Bachelor's degree, supplemented by one or more years of progressively responsible experience in the conduct of clinical or social science research or an equivalent combination of education and experience.
Strong interpersonal and organizational skills.
Excellent communication and interpersonal skills
Ability to apply critical thinking, technical problem solving, and analyzing system specifications.
Highly Desirable Qualifications
Knowledge and some experience (one year) with database programming (e.g. SQL), or relational database systems (e.g. Oracle, Filemaker Pro, Microsoft Access), or statistical packages (SAS or SPSS).
Experience conducting clinical or social science research (minimum of one year).
Previous experience (at least one year) with online data entry systems including remote data entry.
Familiarity with research processes.
Experience in design and development of database system and developing specifications for applications.
Experience managing and/or collecting data in a large research study.
Experience auditing clinical or lab records.
Experience with group presentations.
Knowledge of GCP and ICH guidelines
Application Details: In order to be considered for an interview, applicants must upload a resume and cover letter and mark them as a "Relevant File" to the submission. Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended. Successful candidates will be subject to a criminal background check and credential check. Up to 5 professional references will be requested at a later step in the recruitment process. Remote work will be considered for this position.
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran.
Internal Number: 21001370_1612978285
About University of Iowa
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.