Clinical Research Coordinator II - Neurology

About the role

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.
• Captures and 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.
• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• 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.
• 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.
• Assists with various professional, organizational, and operational tasks under moderate supervision.
• 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.
• Absorbs and manages interpersonal relationships.
• Accounts for all tasks in moderately complex clinical studies.
• Performs other related work as needed.

Requirements

• Minimum requirements include a college or university degree in related field.
• Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
• Preferred qualifications include a Bachelor's degree and experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Qualifications

• 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.
• Work experience in a related job discipline.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Skills

• Understanding of Good Clinical Practices (GCP).

Benefits

• Application Documents: Resume (required), Cover Letter (required).

Pay and Schedule

• Pay Rate Type: Salary.
• FLSA Status: Exempt.
• Pay Range: $60,000.00 - $75,000.00.

Benefits

• Benefits Eligible: Yes.

Equal Opportunity Employer

• 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.