Clinical Trials Research Assistant/Data Manager

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 data management plans and identifying appropriate resources for research projects; assisting with 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 collection and modules; assisting with data processing tasks including data cleaning, reconciliation, and reporting. 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 Protocol Coordination 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.

Protocol Development/ Management and Study Responsibilities

* Assist in development of study and training materials for ongoing clinical trials.
* Assist in development of study-specific data management plans.
* 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.
* Assist in the design of forms to facilitate the collection and tracking of data, subjects, study drugs, biological specimens, and study procedures.

Research/ Clinical Activities; Subject Recruitment and Enrollment

* Assist in monitoring study-specific enrollment reports.
* Provide enrollment reports to internal and external collaborators, as scheduled and as needed.
* Assist in the development and testing of online enrollment, randomization and follow-up procedures for study data collection.

Data Collection and Monitoring

* Assist in designing forms and website modules to facilitate the collection and tracking of data, subjects, study drugs, biological specimens, and study procedures.
* Perform all data processing tasks, such as verifying data, identifying problem data, generating queries to clinical staff, and preparing data for statistical analysis.
* Coordinate the processing and reconciliation of data from participating clinical centers and laboratories.
* 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.

Regulatory Guidelines and Documents

* Assist in preparing training materials and make presentations to clinical center staff on how to perform data processing tasks in compliance with 21 CFR Part 11.
* Assist in designing and generating reports for use in data audits.

Human Resources/ Leadership

* 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.

Education or Equivalency Required

• Requires the academic knowledge of a discipline plus the ability to translate, adapt and apply this knowledge that is generally associated with a Bachelor's degree or an equivalent combination of education and experience.

Required Qualifications

• Excellent written and verbal communication skills and attention to detail required.
• Occasional out-of-state travel may be required.
• Knowledge and considerable experience with Microsoft Office Suite is required.

Desirable Qualifications

• Knowledge and some experience (at least 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).
• Knowledge of 21 CFR Part 11 compliance is desirable.
• Knowledge of GCP and ICH guidelines is desirable.

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.