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Clinical Research Nurse I
3 months ago
Overview
Are you looking for a Great place to work? Our team at Maryland Oncology Hematology is looking for \"star\" talent. If you believe you have what it takes to create a rewarding experience for our Physicians, patients, and team members, we would enjoy the opportunity to speak with you
Maryland Oncology Hematology is dedicated to providing the most advanced cancer care available anywhere in an atmosphere of caring compassion. We have over 15 convenient locations throughout Maryland and in DC.
Job Profile Summary:
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
Job Description
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.
Minimum Job Qualifications (Knowledge, Skills, & Abilities):
Education/Training -
- Graduate from an accredited program for nursing education required (BSN preferred).
- Current licensure as a Registered Nurse in state of practice required.
- Current BLCS or ACLS certification required.
- OCN, SoCRA or ACRP certification preferred.
- Minimum 1 year of nursing experience required, preferably in oncology
- Experience in Microsoft Office required
- Experience in clinical research preferred
- 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
Environment (Office, warehouse, etc.)
- Traditional office environment.
Physical Requirements (Lifting, standing, etc.) –
- Large percent of time performing computer based work is required.
