Job DescriptionJob Description Practitioner
Tranquil Clinical Research cares about the opinion of our employees and we want the world to know what an amazing place Tranquil is to work for. We always do the right thing, our number one job is the rights, safety and well being of our patients, we train hard and we play hard. We know that our employee provides an essential service and therefore we take better care of our employees than any CRO/Phase I unit in the US
Job Title: Part Time Research Nurse Practitioner PRN
Department: Clinical Research
Reports to: CEO
Summary
The role of the study Research Nurse Practitioner is to ensure patient safety and wellbeing. The PRN Research Nurse Practitioner will coordinate and perform study visits under the guidance and supervision of the principal investigator. This is an office-based position, working in the same location as the principal investigator or in the designated clinic.
To be successful in this role, the Research Nurse Practitioner should be able to perform critical patient evaluations, in addition to recognizing logistical problems and initiating appropriate solutions. Ideal candidates will be patient-focused, detail-oriented, have the ability to multitask and be able to collaborate with various role players. The Research Nurse Practitioner must be able to work independently, be a team player, and proactively problem solve.
Qualifications
NP with related clinical experienceExperience working on clinical trials for a minimum of 1 yearKnowledge of FDA regulations and GCPAccuracy, attention to detail and ability to set priorities and meet deadlinesBasic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel
Other Skills required:Excellent bedside manner and patient-centric focusExcellent time management and social skillsHighly motivated with a phenomenal eye for detail
Develop management systems and prepare for study initiation:Assess study feasibility in terms of study's impact on-site resources, labor cost, cost by procedure, potential for problems (such as serious AEs, noncompliance, willingness of subjects to participate, protocol deviations, etc.)Possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibilityReview with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocolReview the protocol summary sheet and the Informed Consent Form for accuracy and clarityDevelop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarityDevelop a mechanism for subject recruitment and ongoing communications with primary care physicians and nursing staff, as appropriate.
Screen and enroll study subjects:Review the study design and inclusion/exclusion criteria with the subject’s primary physicianReview and verify all relevant source documentation in the subject's medical record to confirm study eligibilityReview the protocol, informed consent form and follow-up procedures with potential study subjectsEnsure that the current approved informed consent is signed before subjects are screened and enrolledEnsure that the randomization procedure is followed as per protocol guidelinesDocument protocol exemptions and deviations.
Manage study-related activities, subject compliance, and documentation:Ensure adherence to protocol requirementsSchedule subjects for follow-up visitsAssist investigators in assessment of subject response to therapyReview laboratory data, inform investigator of abnormal values and documentReport to primary care provider as appropriateAssess and document subject compliance with medications and visitsCommunicate with pharmacy staff to assure timely and accurate study drug distributionManage administration of investigational therapyMaintain dispensing logs (if allowed)Maintain copies of any documentation for dispensing of investigational products and/or study-related suppliesOversee specimen collection, storage, and shipmentAttend study-related meetings as appropriateCommunicate regularly with the principal investigator, monitor (and others responsible for conduct of the research) about study-related issues.
Record data and study documentation:Record data as directed using the appropriate media or platformFollow procedures for access and security for electronic data entryReview keyed data for accuracy, as neededSend data to the data collection center on a timely basisMaintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reportsCorrect and edit data as directed and as appropriate.
Monitor and report adverse events:Assess, document and record all AEs as outlined in the protocolReport serious AEs o the Principal Investigator, Sponsor and IRB (and others as required by funding source or as outlined in the protocol).Regulatory documentation:Know and understand all regulatory requirements associated with the conduct of the study assignedMaintain files and documents as regulations dictatePrepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as requiredEnsure that all required documentation is complete and appropriately filed.
Management of site activities during audits and inspections:Prepare for quality assurance audits and regulatory inspections, as neededAct as contact person before, during and after audits and inspectionsProvide all required documentation to auditorsMake all appropriate corrections as requested by auditorsCoordinate site response to audit/inspection findings.
Management of ancillary staff:Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).
Part time - average 20 hours or less.
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