Job Description
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Start Date: ASAP (will need 3 weeks from offer accept to allow enough time to onboard/credential)
-Schedule: 8 am-5pm EST (RN should know due to surgical patient population, start time could be earlier around 5:30-6am, need to be flexible)
-Type of candidate needed: RN w/BS degree ONLY for this study,
NO LPNs/CNAs etc ..
will be administering drug (nasal swab) and prescreen patients for eligibility (inclusion/exclusion), will complete any CRFs associated w/trial and faxing to central team to enter into EDC.
Need to understand/bring at least 1 year of true clinical research coordination experience and knowledge in clinical trials to know how to screen/consent and how a trial runs -Term: 6 months renewable likely as study will run for 1 year
-Interview process: one w/manager Magen (virtual) then decision/offer
-TA: Infectious disease study
Summary: The Research Nurse is responsible for coordinating multiple research protocols and serving as a liaison with local investigators, clinical staff, and research personnel. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a strong fundamental understanding of human subject research.
Major Responsibilities: Duties include but are not limited to:
- Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement"
- During your employment with HRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
- Complete study medication order forms accurately, when needed, and has physician or appropriate designee sign orders prior to medication administration
- Perform routine operational activities for multiple research protocols • Liaise between site research personnel, industry sponsors, and Supervisor
- Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
- Coordinate protocol schedule of assessments from initial submission of feasibility until study closeout
- Coordinate submission and approval for the Site's Facility Review Committee, if applicable
- Provide instruction on research protocols to appropriate staff, including interpretation of test results, observations, and related study data to physicians, nurses, and clinical staff
- Assess the patient and document findings at each clinic visit while on protocol
- Document all specific tasks required by the protocol (i.e. medication forms, quality of life questionnaires, neuro exams, vital signs sheets, times of lab draws, etc.)
- Complete the study medication order form accurately and have the physician or nurse practitioner sign orders prior to treatment
- Ensure that all medications are approved by the appropriate designee prior to initiating treatment or when changing medication regimens
- Accurately calculate and document the BSA, creatinine, STS calculation, 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, and patient phone calls)
- Ensure that follow-up appointments, imaging, or any related procedures are scheduled correctly according to protocol requirements
- Accurately complete all data requests (including queries) and submit with source documentation within the timeframe specified in the SOP
- Generate and track drug shipments, device shipments, and supplies as needed
- Ensure timely and accurate data completion
- Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations • Communicate all protocol-related issues to appropriate study personnel or manager
- Re-consent patients in a timely manner and document process appropriately
Education & Experience: - Associates Degree minimum required
- Bachelors Degrees preferred
- 1+ years of experience in patient care setting; proficient in various electronic applications, Microsoft, EDC, CTMS; knowledge base of medical terminology
- Minimum 1+ years of relevant clinical research experience
Licenses, Certifications & Training:
Registered Nurse - Currently licensed as a registered professional nurse in the state in which he or she practices, in accordance with law and regulation
Knowledge, Skills, Abilities, Behaviors: Knowledge:
- Knowledge of organizational policies, standard operating procedures, and systems
- Emerging understanding and application of ICH guidelines and the Code of Federal Regulations within the clinical research environment
- Working knowledge of medical and clinical research terminology
- Demonstrate competency in EKG acquisition, phlebotomy, and other clinical tasks within nursing scope of work, as needed per licensure
- Maintain HIPAA compliance knowledge and adhere to all HIPAA regulations, per HRI SOPs
Skills: The proficiency to perform a certain task
- Effective communication skills with internal and external customers with internal and external customers
- Strong organizational skills and time management
Abilities: An underlying, enduring trait useful for performing duties
- Interpersonal skills
- Demonstrates a positive attitude in response to suggestions for improvement
- Effectively prioritizes tasks and work assignments
Ref: #568-Clinical
Job Tags
Full time, Local area, Immediate start, Remote job, Flexible hours,