Clinical Trials Research Assistant/Data Manager - Department of Radiology

UIOWA • Iowa City, IA

6d • Onsite

About The Position

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager. This position is responsible for the screening, recruitment, consenting, enrolling, assessment, and monitoring of subjects for studies using novel magnetic resonance imaging to evaluate lung function in chronic lung diseases, including lung transplant rejection, asthma, chronic obstructive pulmonary disease, and lung cancer. The role also involves assuring study compliance, reviewing data quality and management, and communicating concerns to the principal investigator. Other responsibilities include organizing data for analysis, supporting paper and grant submissions, and coordinating research activities with a group of investigators.

Requirements

• Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience
• Six months of clinical research experience
• Excellent written, verbal communication, interpersonal and organizational skills
• Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study.
• Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information
• Knowledge of Microsoft Office Word, Excel, PowerPoint, Outlook, Adobe Acrobat

Nice To Haves

• Ability to work independently and manage multiple priorities or studies at one time
• Previous experience and participation with clinical trials
• Knowledge of regulatory guidelines and procedures as set forth by the IRB
• Research protocol management experience including single and multi-institutional studies
• Experience with medical research data management
• Experience with laboratory functions including, blood draws, IV placement, processing specimens per protocol, as well as storage of specimens, maintaining lab areas, inventories, orders.
• Experience working with Epic, RedCap, Clinicaltrials.gov and IRB submission systems.

Responsibilities

• Screens, recruits, consents, enrolls, assesses, and monitors subjects for both general research and clinical trial projects.
• Assists with subject recruitment by mining databases and EPIC.
• Assists with clinical and data coordination for research activities and sets up supplies for study visits.
• Participates in clinical research visits, which includes Epic documentation, checking vitals, portable pulmonary function testing, drawing blood, and placement of IVs.
• Assists in managing data, including storage, reporting, and auditing to assess quality assurance.
• Performs all data processing tasks; enters data, verifies data, generates queries, etc.
• Coordinates the processing of data from various sites/centers/studies.
• Processes specimens per protocol, stores specimens, maintains lab areas, inventories, and orders.
• Assists in retrieval of basic study data as it pertains to specimens.
• Monitors visit reports for studies.
• Assists with the submission of IRB protocols and works with the department Regulatory Specialist to ensure timely updating of information for submissions.
• Consults with researchers to assist in study planning, development, and support of a data management plan.
• Designs forms to facilitate the collection and tracking of study participant data, drugs, specimens, and study procedures.
• Designs and coordinates field tests for data collection forms and assists in the design of these procedures.
• Manages and maintains protocols.
• Researches, changes, and submits protocol amendments for IRB approval.
• Prepares IRB documents for protocol approval, modifications, and yearly renewals.
• Monitors protocol status as it is processed through the IRB.
• Conducts training of new protocols and changes to existing protocols.
• May provide training to other lab staff as required by the study protocol.

Benefits

• Regular salaried position.
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level