NATURE OF DUTIES : The role requires a Licensed Practical Nurse (LPN) to assist in subject recruitment, manage study-related activities, and ensure regulatory compliance. Key responsibilities include screening and enrolling study subjects, managing documentation and data, monitoring adverse events, and coordinating with healthcare professionals. The LPN will also develop management systems for study protocols, provide training for ancillary staff, and maintain patient confidentiality per HIPAA standards. Enthusiasm for learning and teamwork is essential for optimizing patient satisfaction and achieving study goals.
SPECIFIC DUTIES :
1. Subject Recruitment
- Prescreen medical records for eligibility requirements
- Screen charts (review chart, contact and schedule subjects)
- Present information in the community to recruit for studies
- Present information to healthcare professionals (e.g., MD's, Nursing Services)
- Assist Research Team Leader with monitoring enrollment goals and modify recruitment strategies as necessary
2. Develop management systems and prepare for study initiation
possess a sound and in-depth understanding of each protocol that has been assigned as a primary responsibilityreview with the Principal Investigator / Research Team Leader the inclusion / exclusion criteria, overall structure and requirements of each protocol including utilizing Computer Generation Diagnosis Codes (ICD-10).review 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 including but not limited to physician referral letters.3. Screen and enroll study subjects
review and verify all relevant source documentation in the subject's medical record to confirm study eligibility utilizing all pertinent medical records from outside facilities and / or family members if necessaryreview the protocol, Informed Consent Form, and follow-up procedures with potential study subjectExplain the Informed Consent form to subject (e.g. purpose, duration, risks / benefits)Obtain all required signatures on the Informed Consent FormProvide subject a finalized copy of the Informed Consent FormDocument obtaining of informed consent in source documentMaintain equipment (e.g., calibration and preventative maintenance)ensure 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.4. 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 shipment, maintain supply inventory, maintain equipment (eg., calibration and preventative maintenance)attend study-related meetings as appropriatecommunicate regularly with the Principal Investigator, monitor (and others responsible for conduct of the research) about study-related issues.5. Record data and study documentation
Develop flowsheet for source documentation of study eventsIncorporate applicable historical documents (e.g., surgical reports, pathology reports, medical history)Obtain and record ancillary services reports (e.g., x-ray, pathology, EKG, laboratory)Maintain weekly status reports and subject logsDocument written and verbal communication with study contacts (e.g., subject, sponsor, IRB, laboratory)Schedule and prepare for CRA monitoring visitRecord and document protocol deviationsMaintain communication with the IRB regarding the followingAnnual Updates
Adverse Events
Safety Reports
Protocol Amendments
Expedited or full committee reviews
Informed consent modifications
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.6. Monitor and report adverse events
Apply Pharmacological knowledge to assist the Investigator in determining idiosyncrasies, causality, expected and unexpected resultsAct of Principal Investigators recommendation for adverse event intervention (e.g., stop test article, call subject, retest, treat)Maintain follow-up to determine resolution of adverse event. Record adverse event and relevant information on source document, CRF, and Sponsor specific formassess, document and record all AEs as outlined in protocol. Report serious AEs to the Principal Investigator, sponsor and IRB (and others as required by funding source or as outlined in the protocol).
7. 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 all required documentation is complete and appropriately filed.8. Close-Out
Schedule and prepare for Monitor visitReturn or dispose of unused test articles per Sponsor requirementReconcile test article accountabilityAudit documents and pertinent files and prepare for storageMaintain documents ad required by FDA guidelinesPrepare study summary and / or close-out letter for IRBPrepare study summary for SponsorProvide Method of Document retrieval from storageEvaluate team efforts at siteDocument "dropouts" (e.g., causes, contact efforts)Prepare and respond to Sponsor and FDA audits9. 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.10. Ancillary Staff
Assist Research Team Leader by training and mentoring support staff (e.g., research assistants, clerical staff and volunteers).
11. Perform other related duties as assigned and serves in whatever other capacity deemed necessary for successful completion of the mission and goals of CIS and is in accordance with its patient philosophy
STANDARDS OF PERFORMANCE :
Keeps work area neat and organized. Reports safety issues to team leader immediately.Works efficiently and manages time wisely. Assist other employees when all duties are complete.Communicates any problems, difficulties or concerns regarding job duties to the team leader.Performs all duties without significant error occurring with any regularity.Meets all deadlines and timeframes for completion of assignments.Represents CIS in a professional manner at all times. Demonstrates acceptable ability to interact with physicians, staff ("internal customers") and "external customers" (patients, family members, insurance companies, home health etc.) on a professional level at all times. Exhibits good communication skills with physicians, patients, team leaders, and co-workers at all times.Exhibits whenever possible a harmonious relationship with other CIS employees in order to accomplish the duties and responsibilities of the position. While perfect harmonious relationships with all employees is sometimes not achievable, not more than an occasional complaint should be received by the team leader about the incumbent of this position.The employee shall work and relate cooperatively with all other employees (internal customers) of CIS to assure optimum care for the patients of CIS and to achieve standards of care set forth by the CIS medical staff.Adheres to the CIS Compliance Plan as it pertains to the above specific job duties. Uses best efforts to maintain compliance by following the CIS Corporate Compliance Plan, attending CIS compliance education, following medical documentation guidelines, and communicating concerns regarding compliance issues.Performs accurate and complete documentation in the patient's medical record, when applicable. This includes documentation in both the paper record and the electronic medical record (EMR).Work with the electronic medical record (EMR) staff to maintain quality and work towards future EMR development.Maintains patient confidentiality according to the HIPAA standards of privacy and security.QUALIFICATIONS FOR THE POSITION :
High School GraduateGraduate from an accredited Vocational-Technical school or equivalentCurrent License in LouisianaOne year experience working as a Licensed Practical NurseBasic Life Support certification (BLS) is required
