Clinical Research Coordinator II - Neurology

Clinical Research Coordinator II

The Clinical Research Coordinator II (CRC II) is an onsite, patient-facing, specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Clinical Research Manager. The CRC II supports, facilitates and coordinates independently the daily clinical trial activities and plays a critical role in the conduct of the study.

Responsibilities:

• Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of case report forms, and adverse event reports.
• Coordinates the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence and data integrity.
• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
• Obtains informed consent.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.
• Understands the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
• Ensures compliance with federal regulations and institutional policies.
• May prepare and maintain protocol submissions and revisions.
• May assist in the training of new or backup coordinators.
• Accountable for all tasks in moderately complex clinical studies.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• Performs other related work as needed.

Minimum Qualifications:

Education:

Minimum requirements include a college or university degree in related field.

Work Experience:

Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications:

Education:

• Bachelor's degree.

Experience:

• Clinical research experience or relevant experience.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Preferred Competencies:

• Strong communication skills (verbal and written).
• Excellent interpersonal skills.
• Adaptability to changing working situations and work assignments.
• Ability to comprehend technical documents.
• Ability to develop and manage interpersonal relationships.
• Ability to exercise absolute discretion regarding confidential matters.
• Ability to follow written and/or verbal instructions.
• Ability to handle sensitive matters with tact and discretion.
• Ability to pay attention to detail.
• Ability to perform multiple tasks simultaneously.
• Excellent time management and ability to prioritize work assignments.
• Ability to train or teach others.
• Working knowledge of Good Clinical Practices (GCP).

Application Documents:

• Resume (required)
• Cover Letter (required)

Job Family: Research

Role Impact: Individual Contributor

Scheduled Weekly Hours: 40

Drug Test Required: Yes

Health Screen Required: Yes

Motor Vehicle Record Inquiry Required: No

Pay Rate Type: Salary

FLSA Status: Exempt

Pay Range: $60,000.00 - $75,000.00

Benefits Eligible: Yes

The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.

The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law.