Clinical Trial Coordinator This is an entry-level exempt position. Responsible for coordinating the screening, enrollment, and maintenance of patients on clinical trials. Duties include assuring protocol compliance for all patients on trial, participation in consent process, in collaboration with physicians and other providers ongoing assessments for changes in condition and adverse events, accurate and timely documentation/data entry, participates in education and training of other staff and patients, Ensures 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. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Responsibilities
Key Responsibilities:
Collaborates with physicians and other providers to screen potential patients for 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.
Dispenses investigational drug and provides patient teaching regarding administration.
Maintains investigational drug accountability.
In collaboration with the physician and other providers, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
Responsible for reviewing protocol specific billing guides and submitting billing information to appropriate personnel.
Collaborates with study team on subject recruitment and study enrollment goals.
Works with team to determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
Provides clinical services as required including patient assessments.
Assists with collection and maintenance of regulatory documents in accordance with USOR SOP and applicable regulations.
May collaborate with Research Site Leader in the study selection process.
May participate in scheduling monitoring and auditing visits as well as interact with the monitors/auditors while onsite.
Participates in required training and education of staff and patients.
Assists with 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.
Qualifications:
Current licensure as a Registered Nurse in state of practice required. Current BCLS or ACLS certification required. OCN, SoCRA or ACRP certification preferred. Business Experience Minimum 1 year of nursing experience required, preferably in oncology Experience in Microsoft Office required Experience in clinical research preferred Specialized Knowledge/Skills 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 Ability to solve practical problems and implement solutions 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 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 full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. 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. Salary Scale: The general pay scale for this position at BRCC is $52,968.60- $81,490.24. The actual hiring rate is dependent on many factors, including but not limited to prior work experience, education, job/position responsibilities, location, work performance, etc.
