Nicole DeYear

See responsibilities below

Responsible for:

• Supporting Phase II Heart Failure clinical studies across North America, Europe, and Asia-Pacific as a member of the Clinical Operations team
• Coordinating review and development of study plans
• Negotiating site budgets
• Developing and maintaining relationships with study contractors
• Development of patient recruitment materials
• Reviewing investigator documents and site monitoring reports
• Reviewing and editing informed consent forms
• Performing Trial Master File quality control reviews
• Performing data analyses using tools such as Electronic Data Capture, Excel, and Claude AI
• Collaboration with other departments such as Clinical Drug Supply, Clinical Development, Data Management, Legal, Medical Strategy, Pharmacovigilance, Quality Assurance, and Translational Medicine to ensure we are maintaining study timelines, completing deliverables, and achieving key milestones

See responsibilities below

See responsibilities below

Responsible for:

• Supporting management of clinical trial start-up across more than ten Phase II and Phase III studies across various indications
• Functioning as the primary study-start-up contact for sites selected to participate
• Co-leading multiple studies to successful start-up through collaboration with the Clinical Operations, Contracts, and Budgets teams
• Fostering professional relationships with sponsors, central and local IRBs, and clinical sites
• Leading weekly internal meetings with study teams and external meetings with sponsors
• Co-authoring master informed consent form (ICF) templates for multiple studies
• Mentoring and training four new hires regarding clinical trials, IRB processes, and company processes

Responsible for:

• Reviewing and constructing regulatory submissions for medical devices in compliance with health authority standards in the United States, EU, and Australia
• Conducting research on regulatory standards for various therapeutic areas
• Consulting medical device manufacturers on regulatory requirements
• Collaborating with cross-functional departments to develop strategies for achieving regulatory approvals from health authorities
• Developing and maintaining a database of regulatory information for various medical devices
• Creating training materials on regulatory affairs topics for internal staff members

Responsible for:

• Drawing biochemicals and/or small molecule drugs using ChemDraw software
• Adding, editing, and maintaining biochemical reagent listings on the organization’s website

Responsible for:

• Maintaining the research plants
• Consolidating data samples
• Organizing research data

Responsible for:

• Working with and learning directly from licensed medical assistants, physician assistants, and board-certified dermatologists
• Triaging patients and collecting the reason for their visit, signs, symptoms, and current medications
• Assisting the physician assistant or dermatologist during the patient's appointment by capturing notes, diagnoses, and prescriptions electronically
• Patient charting and submitting prescription orders as directed
• Setting up and cleaning patient rooms, performing pregnancy tests, removing sutures, and providing assistance during patient procedures