Under general supervision, coordinate care for patients on a clinical trial. Act as the main point of contact for questions related to a clinical trial or patient on a clinical trial, monitor patient safety, ongoing maintenance of informed consent, integrity of protocol, accurate documentation and conduct all necessary follow up activities. Ensure site research quality by practicing in compliance with relevant Mary Crowley and US Oncology (USON) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Support and adhere to US Oncology Compliance Program to include Code of Ethics Business Standards.
Essential Job Functions
Managerial
None.
Operational
- In collaboration with the provider
- Ensure protocol compliance is maintained with respect to physician orders.
- Inform consent patients.
- Assess patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and symptom management. Provide patient education. Communicate and document all findings.
- Facilitate dose modification by assessing the patient and lab results, consult the protocol or treatment plan, and calculate dose.
- Report all serious adverse events and provide follow up information. Maintain SAE related records.
- Provide patient updates to investigators, Mary Crowley Team Members, and pharmaceutical company (Sponsor) / monitors.
- Prepare patient calendars and provide to the patient; update as needed.
- Review and resolve queries related to adverse event, concomitant medication use, serious adverse events and other protocol related issues.
- Triage patient phone calls as needed and document relevant information.
- Enhance job knowledge by participating in educational opportunities and by accepting ownership for accomplishing new and different requests; explore opportunities to add value to job accomplishments.
- Maintain patient confidentiality and protect operations by keeping patient care information confidential.
- Train new hires.
- Review, write and provide input on relevant SOPs. Perform all delegated duties and responsibilities in compliance with SOPs.
- Other duties not specifically defined above.
Education and/or Experience
- Graduate from an accredited nursing program, BSN preferred.
- Minimum of 3 years of nursing experience, preferable in oncology, including at least 1 year in clinical research, preferred.
- Proficient in Microsoft Office including MS Word, Excel, Access and PowerPoint; MS Outlook and Internet Explorer.
Required Certificates or Licenses
- Current registered nursing license by State of Texas.
- Current Basic or Advanced Cardiac Life Support (BCLS or ACLS) certification required.
- Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred.
- Oncology Certified Nurse (OCN) certification preferred.
Other Skills and Abilities
- Must possess strong interpersonal skills and ability to work with individuals across all levels of organization, patients and their families.
- Must possess excellent oral and written communication skills.
- Must possess effective analytical, technical, and problem solving skills.
- Must possess strong multi-tasking skills.
- Must possess proficient planning, typing and organizational skills.
Supervisory Responsibilities
None.
Physical Demands
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. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone and other office equipment. Requires normal range of hearing and vision correctable to normal levels. Requires occasional lifting of up to 30 pounds.
Work 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. Work is performed in a clinic environment and requires frequent interaction with staff involved in clinical research and external regulators.