Job Description

Full job description

BASIC FUNCTION

Apply clinical skills requiring specialized licensing to deliver and evaluate research protocols and clinical trials in the Gastroenterology and Hepatology Division of Internal Medicine. The position requires the academic knowledge of a specific discipline and professional licensure in a clinically-related field related to the study. Key areas of responsibility include research/clinical activities, protocol development and study responsibilities, subject recruitment and enrollment, data collection and monitoring, regulatory guidelines and documents, human resources/leadership and financial responsibility.

KEY AREAS OF RESPONSIBILITY

Research/Clinical Activities:

• Perform clinical/health care research activities in a skilled/specialized area.
• Screen patient for study eligibility and consent for clinical trials.
• Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.
• Relay information to principal investigator and verify patient eligibility.
• Administer study medication and identify adverse reactions.
• Administer study infusions; identify and respond to adverse reactions.
• Draw, process and ship labs.

Protocol Development and Study Responsibilities:

• Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex investigator-initiated procedures.
• Coordinate and oversee the administration and maintenance of clinical trial protocols.
• Manage patients with problems related to protocol.
• Oversee CRF development; develop complex study materials.
• Review query reports. Resolve all monitoring visit issues. Assist with coordination of monitor visit schedule. Oversee the monitor visits. Lead remote monitor visit calls.
• Participate and lead the site initiation visits.
• Perform and monitor randomizations.
• Serve as liaison to local health care practitioners, agencies, and sponsors.
• Ensure human subjects protection and provide care that is safe, effective, and efficient.

Subject Recruitment and Enrollment:

• Screen, recruit, enroll and obtain informed consent for clinical research activities and perform skilled work in a specialized area of research.
  Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Prepare study recruitment materials. Develop complex study recruitment materials.

Data Collection and Monitoring:

• Participate in the design, development and testing of clinical research trial data systems.
• Validate data and make recommendations for resolution.
• Revise and implement change in data collection.
• Oversee data entry and queries.

Regulatory Guidelines and Documents:

• Assist with the management and organization of regulatory documentation.
• Assist with the preparation of regulatory submissions.
• Perform on-site audits of research and clinical data.
• Assist with the monitoring of compliance of regulatory guidelines and proper maintenance of documents.
• Assist with the preparation and presentation to the Institutional Review Boards or other submissions and required regulatory documents.
• Recommends corrective action for reportable events.

Human Resources/Leadership:

• May provide functional and/or administrative supervision.
• Mentor new staff under direction.

Financial Responsibility:

• Assist in the development of budget for studies. Contribute to identification of increased cost/inefficient spending and cost containment measures.

UNIVERSAL COMPETENCIES

• Ability to work with a variety of individuals and groups in a constructive and civil manner while appreciating the unique contribution of individuals from varied cultures, race, creed, color, national origin, age, sex, disability, sexual orientation, and gender identity.
• Ability to utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs. Able to demonstrate ethical behavior in diverse situations while producing results.
• Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner. Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.

JOB FAMILY TECHNICAL COMPETENCIES

• Knowledge of theories and methodologies of medical science research; ability to use research processes, tools and technologies to determine the safety and effectiveness of medical products and services intended for human use.
• Knowledge of and ability to provide clinical skills necessary for patient care, education and/or treatment, e.g. history taking, therapeutic planning and monitoring, diagnostic testing, etc., to achieve optimized outcomes in therapy and clinical treatment.
• Knowledge of the relevance of gathering health information used in research for a specific project and appropriate documentation methods; ability to analyze health data related to the project and overall patient health.
• Knowledge of practices, behaviors, applicable laws, rules, and regulations governing proper research conduct; ability to demonstrate ethical and compliant behavior in diverse situations.

SUPERVISION RECEIVED

Supervision is received from the clinical trials research manager.

SUPERVISION EXERCISED

Functional supervision may be exercised over support staff and students.

QUALIFICATIONS

• A current, valid Iowa Registered Nurse license is required.
• A Bachelor's degree in Nursing or an equivalent combination of education and experience is required.
• Excellent written and verbal communication skills are required.
• Occasional overnight travel may be required.
• Clinical research experience is desirable.
• Experience with following specific protocol techniques and management is desirable.
• Knowledge of EPIC and experience with computer software applications is desirable.
• Phlebotomy experience is desirable.

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 14 calendar days and may be removed from posting 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.

For additional questions, please contact michaela-davis-1@uiowa.edu

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