What are the responsibilities and job description for the Clinical Research Coordinator/RN position at Medix?
Overview
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.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide 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.
- Additional responsibilities may include working directly with other (non-USOR) research bases and / or sponsors.
- Identify 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 assure 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.
3-5 Must Have Skills / Qualifications
For California Applicants :
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
