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.
• Ensures compliance with federal regulations and institutional policies.
• 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.
• 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 performs other related work as needed.

Requirements

• Minimum requirements include a college or university degree in related field.
• Knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Preferred Qualifications

• Bachelor's degree.
• Experience coordinating multiple studies (e.g., investigator initiated, industry sponsored, multi-site trials).

Education

• Minimum Qualifications: College or university degree in related field.

Work Experience

• Minimum Qualifications: Knowledge and skills developed through 2-5 years of work experience in a related job discipline.

Certifications

• Preferred Qualifications: Bachelor's degree.
• Preferred Qualifications: Clinical research experience or relevant experience.

Application Documents

• Resume (required)
• Cover Letter (required)