Clinical Research Coordinator/RN

Responsibilities

• Screens potential patients for protocol eligibility.
• Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
• Captivates patient care in compliance with protocol requirements.
• May disburse investigational drug and provides patient teaching regarding administration.
• Maintains investigational drug accountability.
• -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Responsible for accurate and timely data collection, documentation, entry, and reporting.
• Schedules and participates in monitoring and auditing activities.
• Maintains regulatory documents in accordance with USOR SOP and applicable regulations.
• Participates in required training and education programs.
• Responsible for education of clinic staff regarding clinical research.
• May collaborate with Research Site Leader in the study selection process.
• Identifies quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality.
• May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians.
• May oversee the preparation of orders by physicians to ensure that protocol compliance is maintained.
• Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting.
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
• Maintains strict patient confidentiality according to HIPAA regulations and applicable law.

Qualifications

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology.
• SoCRA or ACRP certification preferred.
• or Graduate from an accredited program for nursing education (BSN preferred).
• Minimum seven years of nursing experience, preferably in oncology.
• Experience in clinical research preferred.
• Current licensure as a registered nurse in state of practice.
• Current BLCS or ACLS certification required.
• OCN, SoCRA or ACRP certification preferred.
• Ability to read, analyze, and interpret technical procedures such as protocols, informed consent documents, and regulatory documents.
• Ability to work independently, organize, prioritize, and follow through with results.
• Strong ability multi-task.
• Excellent communication skills.
• Excellent time management skills.
• Strong interpersonal skills to be able to interact with multiple people on many different levels.
• Adequate attention to detail and accuracy.
• Knowledge of medical terminology, nursing assessment, anatomy and physiology, clinical medical, diagnostic tests, radiology, pathology, pharmacology, hematology, oncology, clinical trials and GCP concepts.
• Experience with computer data entry and database management.