Cerebrovascular Laboratory - Clinical Trials Research Assistant

University of Iowa•Iowa City, IA

43d

About The Position

The Cerebrovascular Research Lab in the University of Iowa Department of Neurology is seeking a post-baccalaureate Clinical Trials Research Assistant to manage research study participation including subject recruitment, scheduling, retention, and enrollment. This individual will also administer study protocols and oversee data processing and cleaning.

Requirements

Bachelor's degree or equivalent combination of education and experience. Degree in science or health science field desired.
Experience in research data management and cleaning.
Excellent interpersonal, written, and verbal communication skills
Ability to work in a dynamic, fast-paced environment
Demonstrated organizational skills

Nice To Haves

One year experience in human subjects' research
One year experience in administration of investigator-initiated clinical protocols
Knowledge and experience navigating privacy and confidentiality regulation in human subjects' research, including managing Institutional Review Board (IRB) regulatory requirements.
Knowledge of neurovascular disease
Background in FDA-related submissions
Experience coordinating and scheduling services between multiple departments and/or service providers
Background in clinical drug trials
Experience working with older adults, particularly those experiencing cognitive dysfunction.
Experience with National Institutes of Health (NIH) protocol creation and management

Responsibilities

Participate in the design, development and testing of clinical research trials data systems.
Prepare information upon request for reporting to funding source(s).
Assist in the preparation of material for reports and/ or grant submissions to be written by faculty and staff regarding research projects.
Respond to inquiries about assigned projects and present at informational sessions and panel discussions as requested.
Recruit potential study participants via applicable clinics and impatient hospitalizations.
Screen potential study participants based upon project criteria.
Track and follow up with prospective study participants within project guidelines.
Manage the scheduling of testing and appointments, including arrangement of travel, on-site room and equipment reservations, coordination of the test day agenda, and confirmation of arrangements with scheduled study participants and applicable multi-departmental study team members.
Educate study participants on scope of study, potential risks and benefits, possible alternatives, and study requirements for participants.
Obtain informed consent and other required regulatory documents and monitor participant experience for reportable events.
Maintain contact information of project participants in a secure database and proactively manage scheduling of follow up study visits to comply with project longitudinal goals.
Score and record data collected; perform and oversee data entry and data audits.
Maintain computerized databases, primarily REDCap.
Revise and implement change in data collection and databases as indicated.
Validate data, review query reports, and make recommendations for resolutions.
Initiate meetings with the biostatistical team to ensure data properly reflects study aims and goals. Perform chart review for data collection within protocol guidelines.
Manage and monitor compliance of regulatory guidelines and proper maintenance of documents; prepare regulatory submissions.
Communicate with IRB and FDA staff and investigators, resolve all monitoring visit issues, and recommend corrective action for reportable events.