Job Summary: 

• Know all regulatory requirements and institutional requirements when conducting the study protocols.
• Work in the selected research database to help create the appropriate data fields needed for the outcomes database.
• Create an electronic informed consent form (ICF) within the selected research database.
• Create and maintain Institutional Review Board (IRB) approval and correspondence.
• Obtain, document, and maintain informed consent from potential patients for entry into the database.
• Maintain follow-up outcomes assessments with enrolled patients.
• Data entry/obstruction into the database.
• Respond to patient inquiries via phone or in person on time.
• Quality control of all data and regulatory documents.
• Track and deviation to the Investigational, as well as the sponsor and IRB, following their requirements.
• Maintain good communication with the Principal Investigator, Program Manager, and IRB.

Skills on Resume: 

• Regulatory Compliance (Hard Skills)
• Database Management (Hard Skills)
• ICF Creation (Hard Skills)
• IRB Coordination (Hard Skills)
• Consent Documentation (Hard Skills)
• Patient Communication (Soft Skills)
• Data Quality (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Support the CRCs in general administrative tasks such as assuring the Clinical Trial Management System is up to date (OnCore), and other duties, such as obtaining signatures and collecting checklists, scanning, and filing paperwork.
• Update and maintain the investigator site file or regulatory record for the studies, including printing and filing or storing electronic paperwork such as FDA Forms, Protocol Signature Pages, IRB Correspondence, Delegation Logs, Training Records, CVS, licenses, and any other needed documentation.
• Interface with MedStar administrative and clinical operations staff to assure efficient research participant scheduling.
• Assist in scheduling meetings, including pre-study/selection meetings, site initiation visits, training, and other relevant meetings to support the research team.
• Prepares timely reports as requested by the Supervisor or Director, such as accrual or data management status.
• Abstract medical record data with timely entry into multiple electronic data capture (EDC) systems.
• Work in partnership with the primary CRC, under the direction of the PI, to ensure data is entered on time and mechanisms are in place to report safety events, abnormal lab values that are uncovered in data abstraction
• Answer queries through resolution, assuring there is adequate source data to back up entry into the research database (data should be attributable, legible, contemporaneous, original, and accurate)

Skills on Resume: 

• Administrative Support (Hard Skills)
• Regulatory Filing (Hard Skills)
• Staff Coordination (Soft Skills)
• Meeting Scheduling (Hard Skills)
• Report Preparation (Hard Skills)
• Medical Data Abstraction (Hard Skills)
• Data Entry (Hard Skills)
• Query Resolution (Soft Skills)

Job Summary: 

• Schedules clinical site visits for monitoring as required by clinical monitoring plans
• Prepares for and conducts site qualification, site initiation, interim, and closeout monitoring visits
• Conducts all monitoring with a strong focus on data integrity and patient safety, adhering to GCP protocol and sponsor requirements
• Delivers high-quality and timely reports following each monitoring visit
• Tracks and reports all monitoring-related expenses following the company's travel and expense guidelines
• Works with the Clinical Trial Manager to identify, escalate, and resolve issues at assigned clinical sites
• Maintains Trial Master File (TMF)/Electronic Trial Master File (eTMF) for assigned sites
• Manages the query resolution process with clinical sites and data management groups

Skills on Resume: 

• Site Visit Scheduling (Hard Skills)
• Monitoring Visits (Hard Skills)
• Data Integrity (Hard Skills)
• Report Writing (Hard Skills)
• Expense Tracking (Hard Skills)
• Issue Resolution (Soft Skills)
• TMF Management (Hard Skills)
• Query Management (Soft Skills)

Job Summary: 

• Monitor patients' data and study-related information related to clinical study sites and clinical trial participation. 
• Perform monitoring activities such as initiation, conduct (recruitment, quality data collection), and timely completion of assigned clinical trials.
• Ensure the investigator adheres to the research protocols, regulatory requirements, and good clinical practices, and provide input into the data validation plan.
• Be the frontline liaison between Novartis and sites to ensure successful collaboration, site engagement, and meeting Novartis' expectations on milestones and deliveries.
• Responsible for delivering data as per the required quality standard and monitoring procedures following GCP and ICH, local regulations, and SOPs.
• Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial and perform a Site Initiation Visit. 
• Ensure site personnel are trained on all trial-related aspects, monitor the study sites, and audit facility selection.
• Represent Novartis on specific projects and contribute to the cost center goals and objectives.

Skills on Resume: 

• Patient Data Monitoring (Hard Skills)
• Trial Monitoring (Hard Skills)
• Protocol Compliance (Hard Skills)
• Site Liaison (Soft Skills)
• Quality Assurance (Hard Skills)
• Site Selection (Hard Skills)
• Site Training (Hard Skills)
• Project Representation (Soft Skills)

Job Summary: 

• Provide project management and business development support for clinical trials run in ANZ
• Work within the scope of relevant SOPs, protocols, ICH-GCP Guidelines, and regulatory requirements
• Project oversight and functional leadership of PMs 
• Point of escalation for high-level issues and risk mitigation
• Deliver project milestones on time and within budget
• Develop and prepare documents and reports
• Oversee start-up activities
• Take responsibility for financial negotiations
• Participate in meetings and assist with study design
• Manage study finances
• Collaborate with internal and external stakeholders to achieve this high level of performance
• Liaise with sponsors to update on study progress
• Functionally manage study teams and train staff

Skills on Resume: 

• Project Management (Hard Skills)
• Business Development (Hard Skills)
• Functional Leadership (Soft Skills)
• Issue Escalation (Soft Skills)
• Milestone Delivery (Hard Skills)
• Document Preparation (Hard Skills)
• Financial Management (Hard Skills)
• Stakeholder Collaboration (Soft Skills)

Job Summary: 

• Coordinate patient schedules, data collection, and nursing care
• Assist physicians with skilled procedures
• Order protocol mandated tests, labs, and procedures
• Alert the physician of adverse events, abnormal outcomes, or problematic trends
• Enter protocol data in the database management system
• Follow patients between visits, collaborating with community physicians
• Assist in the creation of case report forms
• Oversee ongoing protocol operations 

Skills on Resume: 

• Patient Coordination (Soft Skills)
• Procedure Assistance (Hard Skills)
• Test Ordering (Hard Skills)
• Event Reporting (Soft Skills)
• Data Entry (Hard Skills)
• Patient Follow-Up (Soft Skills)
• CRF Creation (Hard Skills)
• Protocol Oversight (Hard Skills)

Job Summary: 

• Oversee ongoing protocol operations to ensure study compliance 
• Troubleshoot possible protocol violations/deviations
• Interface with the Institutional Review Board (IRB), study monitors, data manager, and protocol manager 
• Coordinate and ensure proper and timely filing of Adverse Events (i.e., UPs, SAEs, SUSARs)
• Assist with the writing and submission of amendments, annual reports, and other regulatory documents
• Coordinate changes to the protocol or consent documents. 
• Essential duties also include checking patient eligibility for clinical trials, obtaining protocol consents
• Conduct updates for clinical staff on patient care, protocol process and progress, human subjects’ protection, and ICH Good Clinical Practices
• Assist the PI in interpreting research data for the protocol team

Skills on Resume: 

• Protocol Oversight (Hard Skills)
• Violation Troubleshooting (Soft Skills)
• Stakeholder Coordination (Soft Skills)
• Adverse Event Filing (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Protocol Amendments (Hard Skills)
• Eligibility Assessment (Hard Skills)
• Staff Training (Soft Skills)

Job Summary: 

• Act as the medical point of contact during the clinical studies
• Take responsibility for the medical aspects of clinical trials within the clinical study team, and ensure patient safety, quality of medical data, and the best possible drug development
• Support the organization with expert knowledge and insight into the clinical studies, as well as act as a point of reference for the country's medical contact persons
• Review the patient's medical data during the clinical study to identify possible safety or data quality issues
• Support the coding team for the medical history, concomitant medications, and adverse event coding
• Be responsible for the content of the medical sections of protocols/amendments
• Participate in the selection of the Clinical Research Organizations (CRO)
• Train the study teams, monitors, site staff, and CRO's on the medical aspects of the clinical studies, indications, and compounds

Skills on Resume: 

• Medical Liaison (Soft Skills)
• Patient Safety Oversight (Hard Skills)
• Clinical Expertise (Hard Skills)
• Data Review (Hard Skills)
• Medical Coding Support (Hard Skills)
• Protocol Content Creation (Hard Skills)
• CRO Selection (Hard Skills)
• Team Training (Soft Skills)

Job Summary: 

• Oversee and develop clinical projects, including component studies
• Manage clinical studies (Phase I-III) at both the research and operational level
• Author/contribute to protocols, investigator brochures, scientific publications, reviews, presentations, and reports
• Prepare relevant documents for regulatory filings
• Provide strategic input and development support for clinical plans such as enrollment strategy, study design, study timelines, and data analysis
• Develop case report forms, perform medical monitoring, and act as a liaison with Investigators and Site Personnel
• Perform preliminary and exploratory data analyses for clinical trials
• Author clinical study reports, providing input on publication materials
• Collaborate to develop clinical operating guides, maintain secure study files, and review results of these evaluations with appropriate management before implementation
• Interact with KOLs (Key Opinion Leaders)
• Develop presentation materials and/or present at meetings, workshops, or conferences

Skills on Resume: 

• Project Oversight (Hard Skills)
• Study Management (Hard Skills)
• Protocol Development (Hard Skills)
• Regulatory Documentation (Hard Skills)
• Strategic Planning (Hard Skills)
• Medical Monitoring (Hard Skills)
• Data Analysis (Hard Skills)
• KOL Interaction (Soft Skills)

Job Summary: 

• Be present during case support for some of the trial support activities
• Perform study monitoring and meet database locks
• Build relationships with key physicians and site staff
• Support activities with designs, plans, and develop clinical evaluation research studies.‎
• Provide feedback to the global partner on protocol design and functionality from a site level
• Conduct registered and non-registered clinical studies of products that have been ‎ determined to satisfy a medical need and offer commercial potential.‎
• Support activities related to interpreting results of clinical investigations in preparation for a new drug, device, or consumer application.‎
• Oversee and resolve operational aspects of clinical trials in conjunction with project ‎teams 
• Follow standard operating procedures (SOP), good clinical practice ‎‎(GCP), and specific country regulations, and prepare clinical trial budgets.‎
• Clinical supply operations, site, and vendor selection.‎

Skills on Resume: 

• Case Support (Hard Skills)
• Study Monitoring (Hard Skills)
• Relationship Building (Soft Skills)
• Study Design Support (Hard Skills)
• Protocol Feedback (Soft Skills)
• Clinical Investigation (Hard Skills)
• Results Interpretation (Hard Skills)
• Operational Oversight (Hard Skills)