Temporary Clinical Trials Research Assistant

University of Iowa - Iowa City, IA

Full-time - Entry Level

Iowa City, IA

Educational Services

About the position

The Temporary Clinical Trials Research Assistant position at The University of Iowa involves supporting clinical trials within the Radiology/Carver College of Medicine department. This role is crucial for ensuring that all documentation and data related to clinical trials are accurately maintained and processed. The assistant will be responsible for managing the investigator site file, which includes filing documents in the Advarra eRegulatory system according to standardized naming conventions set by the Drug Information Association (DIA). The assistant will also confirm the harmonization of the investigator site file against the trial master file checklist, ensuring that all necessary documents are in place and properly signed where required. In addition to document management, the role includes data curation and processing. The assistant will gather data from Electronic Health Records (EHR) and other sources for entry into the Electronic Data Capture (EDC) system. This involves assessing common problems and obstacles related to data gathering and entry, as well as detecting and summarizing patterns in the data by producing simple reports. The assistant will play a key role in source validation, identifying and documenting available source data, their locations, and types for the investigator site file and trial. This includes creating source templates for workflows and procedures to ensure compliance with trial protocols. The assistant will also be involved in reviewing EHR and other source documents to identify, categorize, and classify adverse events for both routine and expedited reporting. This includes routing adverse event logs through the Advarra eRegulatory system for appropriate review and sign-off, as well as indexing outside safety reports and routing them for signatures as needed. Furthermore, the role requires the deidentification and uploading of appropriate medical imaging as per protocol requirements to the sponsor's outside evaluator. This position is temporary, with a start date of June 18, 2024, and an end date of June 21, 2024.

Responsibilities

• Files documents within the investigator site file in the Advarra eRegulatory system using standardized DIA naming conventions.
• Confirms investigator site file harmonization against trial master file checklist as appropriate.
• Routes training documents for signature within eRegulatory as appropriate.
• Gathers data from EHR and other sources for appropriate EDC entry.
• Assesses common problems and obstacles surrounding data-gathering and/or entry.
• Detects and summarizes patterns in data and findings by producing simple reports.
• Identifies and documents the available source data, their location, and type for investigator site file and trial.
• Identifies the type of information that needs source validation.
• Locates process and procedures for obtaining and confirming data.
• Creates source templates for workflows and procedures to ensure protocol compliance.
• Reviews EHR and other source documents to identify, categorize, and classify adverse events for routine and expedited reporting.
• Routes adverse event logs through Advarra eReg for appropriate review and sign off.
• Indexes outside safety reports and routes for signatures as needed.
• Deidentifies and uploads appropriate medical imaging as per protocol requirements to sponsor's outside evaluator.

Requirements

• Experience with clinical trials and research processes.
• Familiarity with EHR systems and data entry procedures.
• Ability to assess and summarize data patterns effectively.
• Strong organizational skills for document management and compliance.
• Attention to detail in identifying and categorizing adverse events.

Nice-to-haves

• Experience with Advarra eRegulatory system.
• Knowledge of medical imaging protocols and requirements.
• Familiarity with regulatory compliance in clinical trials.

Benefits

• Competitive salary based on experience and qualifications.