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University of Iowa
Iowa City, IA, United States
6 days ago
University of Iowa
Iowa City, IA, United States
6 days ago
University of Iowa
Iowa City, IA, United States
27 days ago
University of Iowa
Iowa City, Iowa, United States
6 days ago


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, tracking and collection of regulatory documents, and data monitoring procedures. This position is responsible for mission-critical research applications and sensitive data, so attention to detail and quality are critical.

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.

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.

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.

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 ensure 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.

See full job posting and application process:


Required Qualifications

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 customer relations skills

Ability to apply critical thinking, technical problem solving, and analyzing system specifications.

Occasional out-of-state travel

Knowledge and considerable experience with Microsoft Office Suite or similar software

Highly Desired Qualifications:

Knowledge and some experience (1 year) with database programming (e.g. SQL), or relational database systems  or statistical packages (SAS or R).

Desired Qualifications:

Experience conducting clinical or social science research (1-2 years).

Previous experience (1 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

Job Information

  • Job ID: 63268027
  • Location:
    Iowa City, Iowa, United States
  • Position Title: Clinical Trials Research Associate
  • Company Name For Job: University of Iowa
  • Industry: Academic Health Center/Academic Medical Center
  • Job Function: Clinical Research Associate
  • Job Type: Full-Time
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 0-1 Year
  • Required Travel: 0-10%

Please refer to the company's website or job descriptions to learn more about them.

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