Clinical/HC Research Associate- Pediatric Neurology

UIOWA • Iowa City, IA

10d

About The Position

The research nurse coordinator will apply clinical and administrative skills in carrying out clinical research protocols. The coordinator will be involved in all aspects of research including patient recruitment and enrollment, patient education and assessment, data collection and monitoring, regulatory documentation, and coordination of research visits with all appropriate disciplines. The successful applicant will independently manage one or more primary research protocols, and work closely with other coordinators assisting with related protocols. Research/Clinical Activities Perform clinical/health care research activities. Meet with patients during visits. Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patients. Review of subject’s medical history. Clinical assessment of study participants. May administer study medication. Educate patients and families about administration and use of study medications. Answer patient questions and address concerns between study visits. Schedule patient visits within parameters specified to study protocol. Assure compliance with study protocol. Work closely with a range of health care professionals to carry out study assessments. Protocol Development and Study Responsibilities Assist in protocol development and provide input into descriptions of routine research procedures. Assure study visit compliance within window of visit schedule. Assist with resolution of monitoring visit issues. Serve as liaison to local health care practitioners, agencies, and sponsors. Subject Recruitment and Enrollment Screen for subject eligibility and obtain informed consent for clinical trials/studies. Relay information to principal investigator and verify patient eligibility. Schedule trial-related procedures and visits. Assist with subject assessments during study participation. Data Collection and Monitoring Collect and enter clinical research data required by the sponsors in a timely manner. Assist with determining validity of data obtained. Maintain detailed record keeping in accordance with clinical research requirements. Regulatory Guidelines and Documents Collect and maintain regulatory documents. Prepare regulatory forms and documentation according to protocol requirements. Report any reportable events to appropriate party within specified time range. Human Resources/Leadership May provide functional and/or administrative supervision. Financial Responsibility Assist in budget development and monitoring for study. Assist in reviewing invoices and work performed before billing.

Requirements

• Master’s degree in nursing or a combination of a Bachelor’s degree in nursing and relevant experience.
• A current, valid Iowa Registered Nurse License.
• At least 1 year of previous clinical experience.
• Demonstrated experience with Microsoft Office Suites.

Nice To Haves

• 1-3 years’ experience and participation with clinical trials.
• Knowledge of Institutional Review Board procedures, FDA regulations, GCP and study sponsor guidelines related to clinical trial research.
• Previous experience with Pediatric patient population.
• Experience in clinical trial management including IRB protocols.
• Previous experience with research subject recruitment.
• Previous experience in a role requiring independent decision making.

Responsibilities

• Perform clinical/health care research activities.
• Meet with patients during visits.
• Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patients.
• Review of subject’s medical history.
• Clinical assessment of study participants.
• May administer study medication.
• Educate patients and families about administration and use of study medications.
• Answer patient questions and address concerns between study visits.
• Schedule patient visits within parameters specified to study protocol.
• Assure compliance with study protocol.
• Work closely with a range of health care professionals to carry out study assessments.
• Assist in protocol development and provide input into descriptions of routine research procedures.
• Assure study visit compliance within window of visit schedule.
• Assist with resolution of monitoring visit issues.
• Serve as liaison to local health care practitioners, agencies, and sponsors.
• Screen for subject eligibility and obtain informed consent for clinical trials/studies.
• Relay information to principal investigator and verify patient eligibility.
• Schedule trial-related procedures and visits.
• Assist with subject assessments during study participation.
• Collect and enter clinical research data required by the sponsors in a timely manner.
• Assist with determining validity of data obtained.
• Maintain detailed record keeping in accordance with clinical research requirements.
• Collect and maintain regulatory documents.
• Prepare regulatory forms and documentation according to protocol requirements.
• Report any reportable events to appropriate party within specified time range.
• May provide functional and/or administrative supervision.
• Assist in budget development and monitoring for study.
• Assist in reviewing invoices and work performed before billing.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees