Job Title: Research Nurse/Research Coordinator/Clinical Study Coordinator
Department: Clinical Research
Reports to: CEO
The role of the study research nurse is to ensure patient safety and wellbeing. The research nurse 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 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 must be able to work independently, be a team player, and proactively problem solve.
- RN/LPN with related clinical experience
- Experience working on clinical trials for a minimum of 1 year
- Knowledge of FDA regulations and GCP
- Accuracy, attention to detail and ability to set priorities and meet deadlines
- Basic Computer Skills required: Microsoft Office Suite, including Word PowerPoint, Excel
- Other Skills required:
- Excellent bedside manner and patient centric focus
- Excellent time management and social skills
- Highly 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 responsibility
- Review with the Principal Investigator the inclusion/exclusion criteria, overall structure, and requirements of each protocol
- Review the protocol summary sheet and the Informed Consent Form for accuracy and clarity
- Develop draft protocol follow-up worksheets and then review the worksheets for accuracy and clarity
- Develop 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 physician
- Review and verify all relevant source documentation in the subject's medical record to confirm study eligibility
- Review the protocol, informed consent form and follow-up procedures with potential study subjects
- Ensure that the current approved informed consent is signed before subjects are screened and enrolled
- Ensure that the randomization procedure is followed as per protocol guidelines
- Document protocol exemptions and deviations.
- Manage study-related activities, subject compliance, and documentation:
- Ensure adherence to protocol requirements
- Schedule subjects for follow-up visits
- Assist investigators in assessment of subject response to therapy
- Review laboratory data, inform investigator of abnormal values and document
- Report to primary care provider as appropriate
- Assess and document subject compliance with medications and visits
- Communicate with pharmacy staff to assure timely and accurate study drug distribution
- Manage administration of investigational therapy
- Maintain dispensing logs (if allowed)
- Maintain copies of any documentation for dispensing of investigational products and/or study-related supplies
- Oversee specimen collection, storage, and shipment
- Attend study-related meetings as appropriate
- Communicate 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 platform
- Follow procedures for access and security for electronic data entry
- Review keyed data for accuracy, as needed
- Send data to the data collection center on a timely basis
- Maintain source documentation for all data entered, including clinic chart visit notes, lab data and procedure reports
- Correct and edit data as directed and as appropriate.
- Monitor and report adverse events:
- Assess, document and record all AEs as outlined in the protocol
- Report 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 assigned
- Maintain files and documents as regulations dictate
- Prepare and submit initial applications to central and local committees (IRBs, biosafety, radiology, etc.), prepare and submit reports, as required
- Ensure 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 needed
- Act as contact person before, during and after audits and inspections
- Provide all required documentation to auditors
- Make all appropriate corrections as requested by auditors
- Coordinate site response to audit/inspection findings.
- Management of ancillary staff:
- Train and supervise support staff (e.g., research assistants, clerical staff and volunteers).