Clinical Trials & Database Management Research Assistant - Internal Medicine
University of Iowa

Job Info

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Support, conduct and manage clinical trials to deliver and evaluate research protocols on the Wahls' team which focuses on dietary and lifestyle interventions to improve diet quality and self-care routines in the setting of multiple sclerosis and other autoimmune conditions. Key areas of responsibility include protocol development/management and study responsibilities; research/clinical activities, subject recruitment and enrollment, data collection and monitoring; regulatory guidelines and documents; staff training/supervision, human resources/leadership; and financial responsibility.

KEY AREAS OF RESPONSIBILITY

Protocol Development/ Management and Study Responsibilities:

Consult with researchers to assist in development of data management plans; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens, and study procedures.

Design and coordinate field tests for data collection forms and assist in design of certification procedures.

Research/Clinical Activities; Subject Recruitment and Enrollment:

May assist with clinical and data coordination for research activities. May screen, recruit, enroll and obtain informed consent for clinical trials.

Data Collection and Monitoring:

Assist in collecting, tracking, and performing data validation; including query resolutions and the reporting of data; conduct audit to assess quality assurance.

Perform all data processing tasks; enter data, verify data, identify problem data, generate queries, etc.

Coordinate the processing of data from various sites/centers/studies.

Regulatory Guidelines and Documents:

Assist in documenting compliance with safety and regulatory guidelines.

Conduct audit to assess quality assurance.

Develop procedures for on-site data audits; participate in audits; design and generate reports for use in data audits; summarize results of audits and write reports.

Human Resources/Leadership:

May provide functional supervision.

Mentor new staff under direction.

Financial Responsibility:

Develop and administer budget for study.

SUPERVISION RECEIVED

Supervision is received from the Principal Investigator.

SUPERVISION EXERCISED

Functional supervision may be exercised over support staff.

Required Qualifications:

A Bachelor's degree or an equivalent combination of education and experience is required.

Excellent written and verbal communication and interpersonal skills are required.

Excellent time management, attention to detail, ability to multi-task, organize priorities, and work independently to meet deadlines is required.

Desired Qualifications:

Microsoft Office required. (MS Word, Excel, PowerPoint, Access)

6 months of experience with clinical research experience

Working knowledge of Good Clinical Practice (GCP) in research

Experience with IRB submissions & modifications for Institutional Review Board applications

Experience with recruitment & enrollment of patients, including informed consent

Previous experience in data collection and entry

Experience with conducting patient assessments

Experience with organization, reporting, and management of study outcome data

Experience supervising students

Experience with clinical research compliance and regulatory guidelines

Experience with writing and updating processes and procedures

Experience with EPIC

Experience with REDCap, I-Cart, HawkIRB

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 14 calendar days.

Successful candidates will be subject to a criminal background check. This position is not eligible for University sponsorship for employment authorization.

With additional questions please reach out to Kiley Skay at kiley-skay@uiowa.edu

Additional Information

• Classification Title: Clin Trials Rsrch Asst/Data Mg
• Appointment Type: Professional and Scientific
• Schedule: Full-time

Compensation

• Pay Level: 3A

Contact Information

• Organization: Healthcare
• Contact Name: Kiley Skay
• Contact Email: kiley-skay@uiowa.edu

This job has expired.