What are the responsibilities and job description for the Clinical Research Coordinator I position at The US Oncology Network?
Overview
Responsible for supporting the management and coordination of tasks for multiple clinical research studies to include screening patients for eligibility and participates in the subject’s study visits and required activities per protocol. 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, and participation in required training and education, 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.Responsibilities
- Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
-Assists with patient care in compliance with protocol requirements.
-May disburse investigational drug and maintain investigational drug accountability.
-Participates in data collection, entry, and reporting for the subjects.
-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.
-Participates in required training and education programs as well as monitoring and auditing activities.
-May work directly with sponsors.
-May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite.
-Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations.
-May assist in the packing and shipping of lab specimens to central vendors.
-May be required to complete Hazmat and/or IATA training.
Qualifications
-Education/Training - associate's degree in a clinical or scientific related discipline required, bachelor's degree preferred. Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology required. Business Experience - Experience in Microsoft Office Experience working with physicians 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
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 may be made 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 may be made 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.)
