Clinical Research Coordinator 2 - Hematology/Oncology

About the role

The Clinical Research Coordinator 2 (CRC2) is a specialized researcher who partners with the clinical Principal Investigator (PI) and under the direction of a departmental or lab research manager. They support, facilitate, and coordinate the daily clinical trial activities and play 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 the case report form, and adverse event reports.
• Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
• Collections, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
• Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• 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.
• May prepare and maintain protocol submissions and revisions.
• Assists in the training of new or backup coordinators.
• Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.

Requirements

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

Qualifications

• Bachelor's degree preferred.
• Experience coordinating multiple studies, such as investigator initiated, industry sponsored, and multi-site trials.
• Awareness of safety hazards and taking appropriate precautions.
• Comprehension of technical documents and ability to create and deliver presentations.

Skills

• Communicate in writing and orally.
• 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.
• Train or teach others.
• Work independently.