Clinical Trials Research Assistant/Data Manager- Radiology

UIOWA • Iowa City, IA

2d • Onsite

About The Position

The University of Iowa Health Care, Department of Radiology is seeking a Clinical Trials Research Assistant/Data Manager! The Clinical Trials Research Assistant/Data Manager 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. In addition, this position will be responsible for assuring study compliance and reviewing data quality and management and communicating concerns to the principal investigator. Other job requirements will include organization of data for analysis, support for paper and grant submissions, and coordination of research activities with a broad range of investigators. Duties include: Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects. Assist with subject recruitment by mining databases and EPIC. Assist with clinical and data coordination for research activities and set 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 IV’s. Assist in managing data, including the storage, reporting and auditing to assess quality assurance. Perform all data processing tasks; enter data, verify data, generate queries, etc. Coordinate the processing of data from various sites/centers/studies. Process specimens per protocol, as well as store specimens, maintain lab areas, inventories, orders. Assist in retrieval of basic study data as it pertains to specimens. Monitors visit reports for studies. Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions. Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures. Design and coordinate field tests for data collection forms and assist in the design of these procedures Manages and maintain protocols. Research, change, and submit protocol amendments for IRB approval. Prepares IRB documents for protocol approval, modifications and yearly renewals Monitors protocol status as it is process through the IRB. Responsible for conducting training of new protocols and changes to existing protocols. May provide training to other lab staff as required by the study protocol. 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. ® Percent of Time: 100% Schedule: Mon - Fri 8:00 am – 4:30 pm Location: Iowa City, IA Pay Grade: 3A https://hr.uiowa.edu/pay/guide-pay-plans

Requirements

• Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field or an equivalent combination of education and experience is required.
• Six months-one year of clinical research experience is required.
• Excellent written, verbal communication, interpersonal and organizational skills are required.
• 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 is highly desired.
• Knowledge of regulatory guidelines and procedures as set forth by the IRB is highly desired.
• 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

• Screen, recruit, consent, enroll, assess and monitor subjects for both general research and clinical trial projects.
• Assist with subject recruitment by mining databases and EPIC.
• Assist with clinical and data coordination for research activities and set 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 IV’s.
• Assist in managing data, including the storage, reporting and auditing to assess quality assurance.
• Perform all data processing tasks; enter data, verify data, generate queries, etc.
• Coordinate the processing of data from various sites/centers/studies.
• Process specimens per protocol, as well as store specimens, maintain lab areas, inventories, orders.
• Assist in retrieval of basic study data as it pertains to specimens.
• Monitors visit reports for studies.
• Assist with the submission of IRB protocols, work with department Regulatory Specialist to ensure timely updating of information for submissions.
• Consult with researchers to assist in study planning, development and support of a data management plan, design forms to facilitate the collection and tracking of study participant data, drugs, specimens and study procedures.
• Design and coordinate field tests for data collection forms and assist in the design of these procedures
• Manages and maintain protocols.
• Research, change, and submit protocol amendments for IRB approval.
• Prepares IRB documents for protocol approval, modifications and yearly renewals
• Monitors protocol status as it is process through the IRB.
• Responsible for conducting training of new protocols and changes to existing protocols.
• May provide training to other lab staff as required by the study protocol.

Benefits

• 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
• Number of Employees: 5,001-10,000 employees