Clinical Research Coordinator (CRC)

About the role

We are seeking a dedicated and talented individual to support the management and coordination of clinical research studies at Maryland Oncology Hematology. This role involves screening patients for eligibility, participating in the informed consent process, and ensuring protocol compliance.

Responsibilities

• Screens potential participants for protocol eligibility.
• Presents trial concepts and details to participants, participates in the informed consent process, and enrolls participants into clinical trials.
• Carefully coordinates participant care in compliance with protocol requirements.
• May disburse investigational product and maintain accountability records.
• Oversees preparation of orders by providers to ensure protocol compliance.
• Packages and ships laboratory specimens to central vendors as applicable.
• Completion of Hazmat and/or IATA training may be required.
• In collaboration with providers, reviews participants for changes in condition, adverse events, concomitant medications, protocol compliance, and response to study treatment.
• Thoroughly documents all findings and participates in data collection.
• Prepares study-related documentation, including protocol worksheets, adverse event reports, institutional review board (IRB) documents, and annual continuing review reports.
• Maintains regulatory documents in accordance with organizational SOPs and applicable regulations.
• May assist with scheduling monitoring and auditing visits, and interact with monitors/auditors as needed.
• May collaborate with research leadership in study selection processes.
• Participates in required training and education programs.
• May contribute to education of clinical staff regarding research procedures.
• Works with staff to develop action plans and performance improvement initiatives to enhance quality.
• May compile and report protocol activity, enrollment trends, data entry compliance, and research financial information to practice leadership and providers.
• May review protocol-specific billing guides and submit billing information to the appropriate personnel.

Qualifications

• Education/Training: Associate’s degree in a clinical or scientific discipline required; Bachelor’s degree preferred.
• Minimum three years of experience in a clinical or scientific field required.
• SoCRA or ACRP certification preferred.
• Experience with Microsoft Office applications.
• Experience working with physicians preferred.
• Experience in clinical research preferred.

Specialized Knowledge/Skills

• Excellent communication skills.
• Strong organizational abilities.
• Able to multi-task effectively.
• Strong time-management skills.
• High level of interpersonal skills to interact with individuals at various levels.
• Strong attention to detail.
• Ability to work in a fast-paced environment.
• May be responsible for basic clinical assessments.

Physical Requirements

• Significant amount of computer-based work required.
• Requires standing and walking for extended periods.
• Occasionally lifts and carries items up to 40 lbs.
• Requires corrected vision and hearing within normal range.