Clinical Research Coordinator II-Annapolis

This is a mid-level exempt position. Responsible for recruiting, screening, consenting, and enrolling patient in clinical trials. CRC II also coordinates and oversees the subject's visits in accordance with the protocol requirements. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers. Acts as resource for the education and training of clinic staff as well as resource for problem solving of complex issues for the implementation of the research process throughout the clinic, process improvements and SOPs. Compiles and reports protocol activity; accrual data, and financial information. Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.

• 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.

• Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
• Minimum three years of experience in a clinical or scientific related discipline required, preferably in oncology.
• SoCRA or ACRP certification preferred.

Business Experience -

• Experience in Microsoft Office
• Experience working with physicians preferred
• Experience working in clinical research is preferred

Specialized Knowledge/Skills -

• Must have excellent communication skills
• Excellent organizational skills
• Strong ability to multi-task
• Excellent time management skills
• Must have strong interpersonal skills to be able to interact with multiple people on many different levels
• Must have a high level of attention to detail
• Must be able to work in a fast-paced environment
• May be responsible for basic clinical assessments

Working Conditions:

Environment (Office, warehouse, etc.) -

• Traditional office environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an

oncology/hematology clinic environment.

Physical Requirements (Lifting, standing, etc.) -

• Large percent of time performing computer based work is required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations will be offered to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range.

(This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.)