Clinical Research Coordinator II

Creighton University; Omaha (NE); Presencial; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

Creighton University is seeking a Clinical Research Coordinator to support clinical projects by gathering information, managing participant progress per protocol, and assisting with data analysis. The role requires discretion and accuracy in reviewing study data and procedures.

The position involves coordinating participant visits, data entry, and regulatory reporting. A related bachelor's degree and 4 years of clinical research experience are preferred, with knowledge of FDA regulations and

Formación

• Must have a Bachelor's degree in a related field.
• Minimum 4 years clinical experience, preferably in a research setting.
• Knowledge of FDA regulatory requirements.
• Knowledge of the principles of research design.
• Ability to maintain confidentiality.
• Ability to operate personal computer and various software packages.

Responsabilidades

• Meets with study participants. Follows study protocol performing duties/testing/data collection.
• Records data into patient research case report forms (CRFs) including results and abnormal findings.
• Schedules appointments for procedures inside and outside the department.
• Maintains study drug and supply inventory and disbursement.
• Reports regulatory and Institutional Review Board issues appropriately (e.g., adverse events).

Conocimientos

FDA regulatory requirements

Principles of research design

Confidentiality

Computer skills

Educación

Bachelor's degree in related field

Descripción del empleo

Job Description

The Clinical Research Coordinator gathers research information for clinical projects. Manages clinical course of research participants according to research protocol. Selects and observes subjects and assists with data analysis. Utilizes discretion, creativity and latitude for decision making.

• Schedule: Monday through Friday, day hours

Description

The Clinical Research Coordinator gathers research information for clinical projects. Manages clinical course of research participants according to research protocol. Selects and observes subjects and assists with data analysis. Utilizes discretion, creativity and latitude for decision making.

• Schedule: Monday through Friday, day hours
• Location: 7500 Mercy Rd. (CHI/CUMC Bergan Mercy)

Responsibilities

• Meets with study participants. Follows study protocol performing duties/testing/data collection. Conducts study required tests and procedures. (Test may include bone density scans, EKG's, balance testing, mental and physical assessments, blood draws, vitals, diary instruction and review, etc.)
• Records data into patient research case report forms (CRF's) to include recording test results and reacting appropriately to abnormal results. Maintains accurate CRF's and source documents
• Schedules appointments for various procedures inside and outside the department. Obtains medical records for any research hospitalizations and various other duties assigned.
• Maintains study drug and supply inventory as well as study drug disbursement
• Reports regulatory and Institutional Review Board issues appropriately (i.e. report adverse events and other regulatory data)

Qualifications

• Bachelor's Degree in related field (science preferred)
• 4 years clinical experience, preferably in a research setting
• Knowledge of FDA regulatory requirements is required
• Knowledge of the principles of research design
• Ability to maintain confidentiality
• Ability to operate personal computer and various software packages

About Us

Creighton University is committed to providing a safe and non-discriminatory educational and employment environment. The University admits qualified students, hires qualified employees and accepts patients for treatment without regard to race, color, religion, sex, marital status, national origin, age, disability, citizenship, sexual orientation, gender identity, gender expression, veteran status, or other status protected by law. Its education and employment policies, scholarship and loan programs, and other programs and activities, are administered without unlawful discrimination. Creighton complies with all applicable laws and regulations governing equal opportunity in the workplace and in educational activities. Applicants with disabilities needing reasonable accommodations to complete the application or hiring process should contact Human Resources at [e-mail]. Creighton University seeks candidates who understand, respect, and can contribute to the University's mission and values.