Clinical Research Coordinator II

About the role

The Clinical Research Coordinator II works under the general direction of the PI within the Section of Endocrinology in the Department of Medicine. The job provides technical support activities related to documents, analyzes, and reports on clinical research data. The CRC supports and provides guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Responsibilities

• Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
• Recruit and interview potential study patients with guidance from PI and other clinical research staff.
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• Carefully coordinate 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.
• Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
• Performs assessments at visits and monitors for adverse events.
• Organizes and attends site visits from sponsors and other relevant study meetings.
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• 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.
• Understand 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.

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 are preferred.

Qualifications

• Bachelor's degree.
• Minimum 2-5 years of clinical research experience or relevant experience.

Skills

• Aware of safety hazards and take appropriate precautions.
• Communicate in writing.
• Communicate orally.
• Comprehend technical documents.
• Create and deliver presentations.
• Develop and manage interpersonal relationships.
• Exercise absolute discretion regarding confidential matters.
• Follow written and/or verbal instructions.
• Give directions.
• Handle sensitive matters with tact and discretion.
• Handle stressful situations.
• Learn and develop skills.
• Maintain a high level of alertness.
• Pay attention to detail.
• Perform multiple tasks simultaneously.
• Prioritize work and meet deadlines.
• React effectively, quickly, calmly, and rationally during conflicts and emergencies.
• Train or teach others.
• Work effectively and collegially with little supervision or as member of a team.
• Work independently.