Research Nurse Phase II/III
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POST DATE 9/15/2016
END DATE 11/22/2016
JOB DESCRIPTIONJob Code: 03058-3425
SARAH CANNON RESEARCH INSTITUTE (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. Focused on advancing therapies for patients, it is one of the world's leading clinical research organizations conducting community-based clinical trials in oncology, cardiology and orthopedics through affiliations with a network of more than 1,000 physicians across the United States and United Kingdom.
We believe our success is dependent on a healthy work environment where staff members are the core of advancing therapies for patients and accelerating drug development. We apply the same compassion and commitment we have for our patients to our co-workers and colleagues and promote an entrepreneurial culture.
Summary of Key Responsibilities:
Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation and submission of adverse experience reports.
DUTIES AND RESPONSIBILITIES:
Duties include but are not limited to:
* Supports enrolling patients onto clinical trials through recruitment, screening, enrollment and follow up of eligible subjects according to protocol requirements.
* Ensures the protection of study patients by timely adherence to protocol requirements/compliance
* Attends monthly staff meetings and teleconferences.
* Attends weekly study status teleconference.
* Maintains patient confidentiality according to ethical and legal requirements.
* Adheres to appropriate Standard Operating Procedures
* Is familiar with the protocols on which the patients are enrolled
* Uses the protocol as the only tool to screen, treat, and follow patients
* Reviews the study design and inclusion/exclusion criteria with physician and patient.
* Complete and document screening/eligibility accurately
* Complete and document the informed consent process accurately and have all parties fully execute the document including HIPAA Authorization
* Complete the inclusion/exclusion form and standard enrollment form accurately
* Assess the patient and document findings at each clinic visit while on protocol
* Document all specific tools required by the protocol (i.e. oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.)
* Screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs
* Complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment
* Ensure that all medications, including antiemetics, are approved by the registrar prior to initiating treatment or when changing medication regimens, such as crossover studies
* Accurately calculate and document the BSA, creatinine clearance, urine protein:creatinine ratio or any other conversions needed per protocol
* Document any interaction regarding the patient that occurs while the patient is enrolled on a protocol, including follow-up and survival (this includes home health intervention, pharmacies, study managers, physicians, and clinic personnel)
* Ensure that follow-up appointments, scans, or any related procedures are scheduled correctly according to protocol requirements
* Inform, document and notify appropriate SCRI personnel when patient comes off study
* Accurately complete all data and query requests and submit with source documentation within the timeframe specified by the study manager.
* Obtain completed and signed waivers prior to submitting forms to enrollment coordinator for investigator-initiated protocols
* Re-consent patients in a timely manner and document process appropriately
* Accurately completes initial SAE report and submits to the Safety Department within 24 hours of becoming aware of the event
* Accurately completes and submits follow-up SAE report to the Safety Department within the timeframe allotted by the Regulatory Department.
* Practices and adheres to the Code of Conduct philosophy and Mission and Value Statement
* During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
* Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience
* Working knowledge of medical and oncology research terminology.
* Working knowledge of federal regulations, good clinical practices (GCP).
* Skills:The proficiency to perform a certain task
* Skills in communication with patients and physicians.
* Abilities:An underlying, enduring trait useful for performing duties
* Ability to communicate and work effectively with a diverse team of professionals.
* Ability to work with minimal supervision at offsite facilities.
Minimum Required: Vocational/Technical School
Preferred: Bachelor s College Degree (4 yr program)
* Clinical experience
* Clinical research experience
* Oncology nurse experience
CERTIFICATION OR LICENSE:
* Current RN license to practice in the state of Tennessee
* Current BLS certification
* OCN Certification preferred
* Current ACRP Certification Preferred
Last Edited: 09/14/2016