Job Description
Description
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) W elcoming
We are welcoming to the community, partners, staff, and patients utilizing the collective strength of our people.
E xcellence
We achieve and deliver our personal and collective best in the pursuit of quality and accessible health care, education, and research.
C ollaboration
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.
A ccountability
We behave ethically, act openly and with integrity in all that we do, taking responsibility for our actions.
R espect
We create an inclusive environment where every individual feels safe, valued, and respected, supporting the well-being and success of all members of our community.
E mpowerment
We commit to fair access to research, health care, and education for our community and opportunities for personal and professional growth for our staff and learners.
University of Iowa Health Care-recognized as one of the best hospitals in the United States-is Iowa's only comprehensive academic medical center and a regional referral center. Each day more than 12,000 employees, students, and volunteers work together to provide safe, quality health care and excellent service for our patients. Simply stated, our mission is: Changing Medicine. Changing Lives. ®
Holden Comprehensive Cancer Center is Iowa's only NCI-designated comprehensive cancer center. The NCI designation recognized our cancer center, and its research scientist, physicians, and other health care professionals, for their roles in advancing cancer research that impacts on our ability to prevent, detect and treat our patients with cancer. Not just a floor, or a building, or even confined to a single college. Holden Comprehensive Cancer Center coordinates all cancer-related research, education, and patient care by faculty from 41 departments and six colleges, as well as UI Health Care and UI Children's Hospital.
Percent of Time: 100%
Work Schedule: Monday - Friday, Hours generally worked between 7:00am-5pm
Pay Grade: 3A
Benefits Highlights: - Regular salaried position located in Iowa City, IA
- Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans
- For more information about Why Iowa?, click here
Qualifications REQUIRED QUALIFICATIONS - Bachelor's degree in communication, business administration, or a related field, or an equivalent combination of education and experience.
- Excellent verbal and written communication skills.
- Excellent organizational skills.
- Proficiency in computer software applications (Word, Excel, Outlook, and Teams).
- 1+ year(s) experience with data entry
- Ability to manage complex information with attention to detail and a high level of accuracy.
- 2+ year(s) experience coordinating multiple projects and diverse functions independently.
DESIRABLE QUALIFICATIONS - Previous experience in clinical research studies.
- Previous experience with clinical oncology research protocols.
- Previous experience with OnCore Clinical Trials Management System
- Previous experience with REDCap
- Working knowledge of medical terminology
- Knowledge of University of Iowa policies and procedures.
Application Process: In order to be considered, applicants must upload
a resume and cover letter (under submission relevant materials) that clearly address how they meet the listed required and desired qualifications of this position .
Job openings are posted for a minimum of
7 calendar days.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
References: Five professional references will be requested and required at a later step in the recruitment process
This position is not eligible for University sponsorship for employment authorization. With additional questions, please reach out to Sarah Waldschmidt at [click to reveal email address] sarah-waldschmidt@uiowa.edu
Job Tags
Full time, Contract work, Monday to Friday,