Start Date: ASAP (will need 3 weeks from offer accept to allow enough time to onboard/credential)
-Schedule: 8am-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
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
