The US Oncology Network
Location
Bestgate Terrace, Maryland
Salary
$51,545 - $88,987 / YEAR
The Clinical Research Coordinator II is responsible for recruiting, screening, consenting, and enrolling patients in clinical trials while ensuring protocol compliance. This role also involves coordinating patient care and maintaining regulatory documents in accordance with applicable regulations.
Candidates must have an associate's degree in a clinical or scientific discipline, with a bachelor's degree preferred, and at least three years of relevant experience, preferably in oncology. Certification from SoCRA or ACRP is preferred, along with strong communication and organizational skills.
Key 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 clinical trials. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug. Maintains investigational drug accountability. Oversees the preparation of orders by physicians to assure that protocol compliance is maintained. Packages and ships lab specimens to central vendors where applicable. Required to complete Hazmat and/or IATA training. 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 and participates in data collection of all subjects. Responsible for preparing study-related documentation such as protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite. May collaborate with Research Site Leader in the study selection process. Participates in required training and education programs. May be responsible for education of clinic staff regarding clinical research. Collaborates with staff in the development of action plans and performance improvement opportunities with staff to improve quality. May be responsible for compiling and reporting protocol activity, accrual trends, data entry compliance, and research financial information to practice administration and physicians. May be responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.
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