Clin Trials Rsrch Specialist - ICTS Coordinator Core

We are seeking a Clinical Trial & Data Management Research Specialist in the Institute for Clinical and Translational Science will be an integral member of the research team in the Institute for Clinical and Translational Science. This position will provide support for the ICTS by performing activities which are vitally important to ICTS mission, as well as to grow and foster innovation through research support endeavors. The clinical trial research specialist/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols.

Duties to include but not limited to:

Research/Clinical Activities, Subject Recruitment and Enrollment

• Function as the specialist/technical expert in a specific skilled/specialized area.
• Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
• Coordinate the screening of patients for study eligibility and consent for clinical trials.
• Educate patient/participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient/participant.
• Develop and coordinate the delivery of information to principal investigators and verify participant eligibility.
• Administer study treatments and identify adverse reactions.
• Review new protocols and assign to appropriate staff.
• Screen, recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
• Develop new recruitment plans and methods for new studies, provide ongoing assessment to determine if plan is successful.
• Develop complex study recruitment materials for new and ongoing studies.

Protocol Development/Management and Study Responsibilities

• Develop, edit, coordinate, manage, and maintain protocols.
• Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assess participants for problems related to protocol, communicate with the Principal Investigator to maintain proper protocol conduction by the study team.
• Oversee CRF development, database development and maintenance.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials used in conduction of study.
• Communicate with local health care practitioners, agencies, and sponsors as needed.

Data Collection and Monitoring

• Oversee the design; development and testing of clinical research trial data systems for new studies.
• Maintain communication between health care clinical information systems and research data systems.
• Collect and validate data. Make recommendations for query resolution.
• Assist with identification of data problems and implement change as needed.

Regulatory Guidelines and Documents

• Manage and organize regulatory documentation.
• Prepare and submit regulatory documents.
• Assist sponsor with on-site audits of research and clinical data.
• Monitor and maintain compliance of regulatory guidelines and documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• Develop and carry out corrective action plan for reportable events.

Financial Responsibility

• Develop and administer study budgets.
• Participate in preparation of grant applications for extramural funding.
• Assist with tracking and reconciling grant budget free balances.
• Identify opportunities to ensure that grant funding is being used as intended and awarded.

Human Resources/ Leadership:

• May assist with hiring and provide management of the day-to-day performance of staff; assure staff are compliant with UI policies and procedures.
• Identify education/training needs and develop required training programs to meet study needs.
• Educate and mentor staff at all stages of development and growth.

For a full job description, please send an e-mail to the contact listed below.

About ICTS: The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation.

Percent of Time: 100%

Pay Grade: 5A

https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights:

• 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

Required Qualifications

• A Master's degree in a related field or an equivalent combination of education and experience is required.
• A minimum of five years of related research protocol management experience including study start-up, data collection, entering, tracking, maintaining data, and troubleshooting study conduction.
• Experience designing, developing, and implementing recruitment program materials.
• Working knowledge of Good Clinical Practice (GCP) in research.
• Excellent written and verbal communication skills.
• Experience developing and working with research budgets/billing.
• Ability to work nights and weekends.
• Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).

Desirable Qualifications

• Certification in Clinical Research Conduction
• Experience with REDCap, Epic and ACCESS.
• Experience using EPIC subject identification and recruitment.
• Previous experience in data collection and entry.
• Experience in processing research regulatory documents and budget preparation.
• Excellent time management skills and ability to perform detail-oriented work.

Application Process:

In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:

Resume

Cover Letter

Job openings are posted for a minimum of 7 calendar days and may be removed from positing and filled any time after the original posting period has ended.

Successful candidates will be required to self -disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.Hybrid within Iowa: This position is eligible for a combination of on-campus and remote work. Remote work must be performed at a location within the state of Iowa and comply with the remote work program and related policies.

For additional questions, please contact Amy Stewart at amy-stewart@uiowa.edu

This position is not eligible for University sponsorship for employment authorization.

Additional Information

• Classification Title: Clin Trials Rsrch Specialist
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 5A

Contact Information

• Organization: Healthcare
• Contact Name: Amy Stewart
• Contact Email: amy-stewart@uiowa.edu