Pre-Study Clinical Trials Research Assistant - Cancer Center

The Holden Comprehensive Cancer Center at the University of Iowa is seeking a Pre-Study Clinical Trials Research Assistant is responsible to assist the Holden Comprehensive Cancer Center’s (HCCC) Clinical Trials team with data management and reporting activities.  This role is charged with collaborating with the Pre-Study Clinical Trials Research Associate to maintain and coordinate early study start-ups (pre-study efforts) for all cancer trials.  Key areas of responsibility include data monitoring, clinical trials pre-activation workflow processes, and communicating with study sponsors to efficiently move clinical trials through pre-study processes

• Assist in maintaining documentation of protocols, relevant data, and follow-up correspondence with relevant stakeholders.

• Gather relevant data for metrics, information tracking, ensuring compliance and adherence to deadlines.  Metrics include but are not limited to: feasibility questionnaires, confidential disclosure agreements (CDAs), TREC review, etc.

• Responsible for follow-ups on incomplete data entry and/or outstanding queries.

• Facilitate sponsor understanding and adherence to site standard operating procedures (SOPs)

• Attend protocol meetings and other UI Health Care Study Sponsor meetings to communicate CRS timelines and outline/define sponsor expectations; may participate on committees as appropriate.

• Support REDCap database system including development of research forms.

• Develop, implement, and maintain communication tools (e.g. templates, trackers, standardized responses, and shared documentation) to improve efficiency, clarity, and timeliness in communication with study sponsors, contract research organizations (CROs), and other external partners.

• Track and manage clinical trial budget communication.

• Review budget details for consistency and feasibility, identifying any discrepancies or areas requiring clarification prior to submission.

• Communicate University of Iowa informed consent documentation requirements to industry sponsors

• Maintain organized records of budget correspondence to support research operations and provide financial transparency across research teams.

SUPERVISION RECEIVED:

Pre-Study Clinical Trials Research Associate

SUPERVISION EXERCISED:

None

UI Health Care Core Values (WE CARE)

Welcoming

We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people. 

Excellence

We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.

Collaboration    

We collaborate with health care systems, providers, and communities across Iowa and the region as well within our UI community. We believe teamwork- guided by compassion- is the best way to work.