Job Summary:

• Ensure informed Consent has been obtained prior to performing any study procedures
• Review screening documentation and approves subjects for admission into the study in discussion with the Primary Investigator.
• Document all findings in subject specific source documents
• Provide ongoing assessments of study subjects including any potential Adverse Events or Serious Adverse Events and ensures proper reporting and documentation of such events
• Perform assessments and physical examinations as a part of clinical study study procedures
• Provide medical management of Adverse Events as appropriate
• Communicate with Sponsors as appropriate
• Provide coverage for Primary Investigator

Skills on Resume:

• Clinical Compliance (Hard Skills)
• Subject Approval (Hard Skills)
• Data Documentation (Hard Skills)
• Safety Monitoring (Hard Skills)
• Clinical Assessments (Hard Skills)
• Event Management (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Investigator Support (Soft Skills)

Job Summary:

• Screening of all new patients for actively enrolling clinical trials.
• Attendance and active participation in each start up meetings.
• Presentation of new clinical trials at the Neely Center for Clinical Cancer Research.
• Attendance and active participation in each assigned New Study.
• Assist Principal Investigators in obtaining consent from clinical trial patients.
• Registration and randomization of all clinical trial patients, based on study sponsor requirements.
• Scheduling study patient visits for all clinical trial patients.
• Perform nursing assessments of all clinical trial patients.
• Nursing note preparation and telephone triage.
• Documentation and processing of all internal SAEs for all clinical trial patients.
• Daily completion and submission of Study Encounter Forms for all clinical trial patient.

Skills on Resume:

• Patient Screening (Hard Skills)
• Meeting Participation (Soft Skills)
• Trial Presentation (Soft Skills)
• Study Support (Soft Skills)
• Consent Assistance (Soft Skills)
• Patient Registration (Hard Skills)
• Visit Scheduling (Hard Skills)
• Nursing Assessment (Hard Skills)

Job Summary:

• Oversee clinical trials for cancer research including recruiting patients, enrolling patients, consenting patients
• Administering drug product to patients, and managing care of the patient during the clinical research trial.
• Educate patients on clinical trial protocols, enrollment process, side effects, follow up visits, and at home care.
• Coordinate with principal investigator (MD, DO, NP, PA) to ensure quality of care and cost-effective care for the patients.
• Review medical charts, extract data, input data, and write up summaries in relation to the clinical trial.
• Describe the studies and obtain fully informed consent from participants before carrying out a range of clinical assessments including venepuncture and cannulation.
• Interact and engage with participants throughout the study period, answer any questions and liaise with multidisciplinary teams.
• Expected to be able to describe the studies and obtain fully informed consent from participants before carrying out a range of clinical assessments including venepuncture and cannulation.

Skills on Resume:

• Trial Oversight (Hard Skills)
• Patient Administration (Hard Skills)
• Patient Education (Soft Skills)
• Care Coordination (Soft Skills)
• Data Management (Hard Skills)
• Consent Procurement (Soft Skills)
• Participant Engagement (Soft Skills)
• Clinical Assessments (Hard Skills)

Job Summary:

• Maintain current nursing knowledge related to assessment, planning, implementation and evaluation and care of adult oncology patients.
• Analyze clinical research protocols for appropriateness to open based on oncology patient population and protocol requirements of standard vs. non-standard of care. 
• Prepare summary of proposed protocol and submit for PAMC administrative review for assessment of feasibility.
• Provide ongoing assessment of oncology patients enrolled to complex cancer treatment clinical trials, coordinates nursing plan of care according to protocol and patient needs. 
• Documents all clinical observations to assure and maintain high quality research necessary for meaningful clinical trials
• Assuring appropriate patient interventions to address identified patient problems.
• Responsible for subject recruitment for studies from many diverse research agencies at levels to meet accrual commitments. 
• Assesses potential patients for study enrollment eligibility, appropriateness of enrollment to specific trial. 
• Collaborates with physicians and other caregivers to identify appropriate study candidates.
• Maintain confidentiality standards for all potential and enrolled patients, complies with federal HIPPA regulations.
• Coordinate implementation of protocol treatment and follow-up. 
• Coordinates diagnostic, surgical and other procedures, or physical exams specific to study.
• Monitor investigational agents according to protocol guidelines. 

Skills on Resume:

• Oncology Nursing (Hard Skills)
• Protocol Analysis (Hard Skills)
• Feasibility Reviews (Hard Skills)
• Patient Assessment (Hard Skills)
• Clinical Documentation (Hard Skills)
• Patient Recruitment (Hard Skills)
• Confidentiality Compliance (Hard Ski

Job Summary:

• Anticipates potential unknown or severe toxicities and assesses patients for toxicities and tolerance to treatment. 
• Implements treatment modifications and reports all adverse events according to federal and IRB guidelines.
• Coordinate tumor and other specimen collection and submission specific to study adhering to applicable shipping federal regulations. 
• Assures ongoing informed consent process and patient advocacy during the process according to guidelines per Federal Office for Protection of Human Subjects.
• Assure ongoing compliance with all IRB and department policies for regulatory documentation of research processes.
• Provide education and inservice to other medical or nursing staff regarding investigational therapy, potential toxicities, protocol procedures and available resources.
• Act as liaison between sponsoring organization, investigators, physician, patient, and all personnel involved in implementation of protocol to facilitate access to studies.
• Assure compliance with Medicare research funding rules and regulations by collaborating with pharmaceutical industry staff, private practice and health system bill staff.
• Attend cancer/tumor conferences and provide information pertinent to current clinical trials as they relate to patient cases presented.
• Assure compliance with all system and regulatory Quality Assurance requirements.
• Act as an additional resource for patients, their families, and other customers requiring assistance accessing information about cancer and / or cancer treatments.

Skills on Resume:

• Toxicity Assessment (Hard Skills)
• Treatment Coordination (Hard Skills)
• Consent Management (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Medical Education (Soft Skills)
• Protocol Liaison (Soft Skills)
• Funding Compliance (Hard Skills)
• Quality Assurance (Hard Skills)

Job Summary:

• Help implement clinical studies in which volunteers are enrolled, inoculated with viruses, and monitored over the course of infection. 
• Help recruit patients admitted with acute respiratory infections.
• Ensure the overall safe and well-regulated conduct of these studies
• Assist with the ethics and project management of the clinical studies.
• Along with other research nurses and clinical fellows
• Liaise with healthy volunteers and patients
• Screen participants for enrolment
• Monitor participants during in-patient stays
• Undertake clinical study procedures (including phlebotomy, nasal sampling and assisting with bronchoscopy)
• Collect and input clinical data.

Skills on Resume:

• Study Implementation (Hard Skills)
• Patient Recruitment (Hard Skills)
• Study Regulation (Hard Skills)
• Ethics Management (Soft Skills)
• Patient Liaison (Soft Skills)
• Participant Screening (Hard Skills)
• Patient Monitoring (Hard Skills)
• Data Collection (Hard Skills)

Job Summary:

• Clinical duties include coordination of all study visits, including scheduling radiological scans, cardiograms, laboratory testing, drug administration and all other required study procedures.
• Perform ECGs, research lab draws, processing and shipment of samples. 
• Carries out all activities related to study implementation, screening, consenting and enrollment of participants, data collection and abstraction, follow up maintenance, through study close out.
• Work directly with sponsors and their representatives to ensure that study guidelines are followed, data and source properly collected and recorded in the multiple electronic data capture platforms. 
• Works directly with Principal Investigator, patients and clinical team within the Inova Heart and Vascular Institute. 
• Knowledge of coordinating Phase I through IV clinical trials in a high enrolling environment on multiple studies with a various levels of complexity.
• Work within different disease groups and provide backup to team members 
• Maintain all required Inova Nursing competencies.
• Adheres to GCP, FDA, and Inova Health System guidelines when implementing research studies to ensure highest quality research and human subject protection within Inova Health System from site selection to study closure. 

Skills on Resume:

• Study Coordination (Hard Skills)
• Clinical Procedures (Hard Skills)
• Study Implementation (Hard Skills)
• Sponsor Liaison (Soft Skills)
• Trial Management (Hard Skills)
• Clinical Trial Phases (Hard Skills)
• Team Support (Soft Skills)
• Regulatory Adherence (Hard Skills)

Job Summary:

• Ensures study compliance with regulatory requirements, including amendments, continuing reviews and IRB submissions.
• Coordinates financial aspects of study implementation and management from protocol feasibility through study closeout per Inova Research Center and Research Department policies and guidelines. 
• Works directly with Inova Research Business office, Finance Team and Revenue and Billing team to ensure proper implementation of budget, coverage analysis and matrices. 
• Ensures accurate billing and payment for participants and sites.
• Utilizes and adheres to Inova standards, ICHGCP and DHHS (OHRP and FDA) guidelines to ensure the highest quality research and Human Subject Protection within Inova.
• Performs regular QA assessments of data and outcome measures. 
• Communicates effectively and works in collaboration with the research team in order to meet research study and departmental objectives. 
• Respects and understands other clinical disciplines and departments.
• Makes a continuous effort to foster self development, enhance work related skills and improve job performance and expertise.

Skills on Resume:

• Regulatory Compliance (Hard Skills)
• Financial Coordination (Hard Skills)
• Budget Implementation (Hard Skills)
• Billing Accuracy (Hard Skills)
• Quality Assurance (Hard Skills)
• Data Assessment (Hard Skills)
• Team Collaboration (Soft Skills)
• Professional Development (Soft Skills)

Job Summary:

• Performs conduct procedures in strict compliance to the study protocol, Good Clinical Practice standards, Standard Coproducing Procedures (SOPs), quality (QA/QC) procedures, OSHA guidelines and other state and local regulations as applicable.
• Oversees and monitors the well-being and safety of study participants.
• Facilitates verbal direction from Principal Investigator (PI), ensures follow-through.
• Provides ongoing assessment of the study subject/patient to identify Adverse Events (AEs)
• Ensures proper documentation and reporting of all AEs.
• Enforces rules and regulations with study participants.
• Maintains compliant, clear, and accurate study charts and documentation.
• Oversees the work of the research technicians and laboratory technicians on the conduct floor
• Provides leadership to the clinical study team in absence of study manager or supervisor.

Skills on Resume:

• Protocol Compliance (Hard Skills)
• Participant Safety (Hard Skills)
• PI Direction Follow-Up (Soft Skills)
• Adverse Event Monitoring (Hard Skills)
• AE Documentation (Hard Skills)
• Regulation Enforcement (Hard Skills)
• Documentation Integrity (Hard Skills)
• Team Leadership (Soft Skills)

Job Summary:

• Act as the main coordinator of various Investigator Initiated and Industry Sponsored clinical trials
• oordination of study visits as per study protocol, coordinating with clinic staff to ensure proper documentation and timing of research-related procedures
• Planning, implementation, and maintaining of data collection and analysis systems in support of research protocol.
• Blood collection and clinical follow-up of research participants according to the study protocol
• Timely completion of all study documentation forms, including case report forms (CRFs), adverse events reports, queries and other study specific documents
• Review subject’s informationand laboratory reports in preparation for the investigator’s 
• Support and supervise other research nurses, coordinators and research staff members.
• Performing miscellaneous job-related duties as assigned by supervisor
• Work directly with the Principle Investigator, the research team and collaborating laboratories/co-investigators at the study site to ensure the smooth running of all the clinical aspects of studies
• Under the supervision of the Project Manager, coordinate study activities at the study site to ensure.

Skills on Resume:

• Trial Coordination (Hard Skills)
• Visit Scheduling (Hard Skills)
• Data System Management (Hard Skills)
• Clinical Sampling (Hard Skills)
• Documentation Accuracy (Hard Skills)
• Information Review (Hard Skills)
• Team Supervision (Soft Skills)
• Study Site Collaboration (Soft Skills)

Job Summary:

• Perform study procedures (g., venipunctures, obtain and process biological specimen samples, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Principal Investigator and Sub-Investigators, Director, Associate Director, and Clinical Research Coordinators.
• Perform duties of Clinical Research Coordinator under the supervision of the Principal Investigator and Sub-Investigators, Manager, Clinical Operations, and Clinical Research Coordinators.
• Record study data in the source documents, evaluate and review study data to ensure accuracy and completeness.
• Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.
• Develops a strategy for implementing study procedures in compliance with the study protocol.
• Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
• Responsible for maintaining emergency medication in the crash cart.
• Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
• Assists in the screening of research subjects to evaluate their eligibility for a clinical study.
• Creates and performs QC procedures.
• Assists in the reconciliation of IPs and maintaining accountability.
• Acts independently to determine methods and procedures on new assignments and may supervise the activities of other Clinical Services personnel (g., Laboratory and Medical Technicians/ Assistants, Administrative Assistants, and Recruiters.)
• Shows desire and initiative to increase knowledge and skills in clinical research.

Skills on Resume:

• Procedure Execution (Hard Skills)
• Data Recording (Hard Skills)
• Protocol Compliance (Hard Skills)
• Event Reporting (Hard Skills)
• Emergency Prep (Hard Skills)
• Consent Admin (Soft Skills)
• Subject Screening (Hard Skills)
• Quality Control (Hard Skills)

Job Summary:

• Accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. 
• Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.
• Assist in Study Preparation, including developing of new clinic SOPs when required, review of research protocols, writing of informed consents, and design of Case Report Forms (CRFs).
• Perform and/or study coordination, including scheduling of protocol-specific screening and follow-up visits and performing interval interviews and assessments at study visits for protocol-specific data.
• Maintain Complete Study Documentation, including subjects’ reports and progress notes, and document protocol deviations.
• Monitor Test Article Accountability, including storage and accountability log.
• Ensure proper collection, processing and shipment of laboratory specimens collected during the study.
• Assist in Recording and Reporting of Study Adverse Events.
• Coordinate Study Close-Out, including sponsor/monitor closeout visit.
• Activities will entail coordination, actual performance, guidance, monitoring and/or oversight as directed and may occur in various combinations and times depending on workload and staffing.
• Prepare Monthly Activity Reports, Screening and Volunteer Disposition logs, and Help Compile Final and Annual Reports for the Study.
• In addition to the above enumerated duties and responsibilities, the Clinical Research Protocol Nurse may be assigned additional duties on an “as needed” basis in conjunction with projects initiated by the Department Chief.

Skills on Resume:

• Study Preparation (Hard Skills)
• Coordination (Soft Skills)
• Documentation Maintenance (Hard Skills)
• Test Monitoring (Hard Skills)
• Specimen Management (Hard Skills)
• Adverse Event Reporting (Hard Skills)
• Study Close-Out (Hard Skills)
• Report Preparation (Hard Skills)