Kandace Spotanski, Mmhc, Ccrc Email & Phone Number

Nashville, TN, US

• Responsible for the successful coordination and execution of projects, including the coordination of resource distribution across projects
• Supervises the creation of study budgets and proposals for new clinical trials
• Provides critical input into ongoing clinical trials, including serving as a subject matter expert for the Clinical Operations team and providing insight into and management of Change Orders and budget modifications.
• Provides oversight during client meetings.
• Assists in the tracking of critical performance metrics.
• Coordinates with key sub-groups within the Clinical Operations practice, including Project Management, Monitoring, and Pharmacovigilance, as it relates to new projects and budgets.

• Managed multiple fully decentralized clinical research studies to ensure studies were conducted in accordance with approved scope of work/budget, ICH GCP guidelines, and FDA regulations and within established timelines
• Created and reviewed clinical study documents, including protocols, ICFs, study budgets, site log/form templates, study manuals and operational plans outlining planning, execution, and closeout milestones
• Established metrics to monitor study KPI to continuously assess study progress study status, timelines, and budget expenditures; identify and recommend implementation plan for efficiency measures
• Preformed gap analysis on contracts
• Scoped, drafted and executed change orders
• Preformed financial reconciliation monthly, quarterly and annually on multimillion-dollar projects

Nashville Metropolitan Area

• Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents including (but not limited to) MS Project Plans.
• Using principles of Servant Leadership to guide by example with professional and collaborative conduct
• Exploring new opportunities to add value to organization and departmental processes
• Possessing a thorough understanding of the project contract and totals needed for monthly revenue reporting
• Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost managementTherapeutic Areas: Neurology–PD, Alzheimer’s Disease (AD), Friedreich's Ataxia.

Greater Nashville Area, TN

• Identifying critical project success factors for tracking, analysis and reporting
• Performing financial tasks including monthly billing, forecasting, project scope reviews and amendments, and pass-through cost management
• Contributes to team effort by exploring new opportunities to add value to organization and departmental processes
• Reviewing study requirements and response assessment criteria and collaborates with key stakeholders to develop study start-up activities and associated documents
• Defining project plans (i.e. timelines, milestones and limitations for project staff)
• Communicating timely, appropriate project information to project teams, sites and company/sponsor representative(s)

Greater Nashville Area, TN

• Coordinated an international multi-site, randomized clinical trial
• Audited in real-time affiliate site data
• Preformed annual on-site Fidelity visits
• Monitored and maintained quality of data across all (10) sites
• Expanded breast oncology knowledge
• Utilized Microsoft Office products, EPIC, OnCore and REDCap

Greater Nashville Area, TN

• Gained oncology experience and medical understanding
• Consented eligible participants
• Accurately conducted participant visits with direct entry into electronic database (REDCap)
• Created reports and analytics for determining study progress
• Acquired practical knowledge of circumferential measurement for Lymphedema detection
• Developed streamline procedures for clinic interaction

Greater Nashville Area, TN

• Created IRB approved screening implements for more successful patient recruitment
• Preformed phone screening assessments to determine participant eligibility
• Firm understanding of multiple study protocols
• Maintained a database of over 30,000 participants
• Managed multiple social media platforms (Facebook, Twitter, LinkedIn, Google+)
• Produced electronic communications to keep participants engaged in studies

Brentwood, TN

• Acumen nEHR is a Nephrology specific EHR. This product is now marketed as on the EPIC platform as Acumen Epic Connect.
• Evaluated the accuracy of the material in Salesforce
• Applied problem solving skills to duplicate accounts and misfiled cases to correct
• Coordinated with peers to ensure tasks were efficiently completed
• Discovered new accounts and contacts
• Developed protocols for task completion

Evansville, Indiana Area

• Imported data obtained from study participants in to EDCs such as Oracle and Novo Nordisk
• Administered informed consent to participants
• Acquired Good Clinical Practice certification
• Prepared laboratory samples for shipment
• Gained practical knowledge of phlebotomy
• Expanded pharmacological knowledge familiarity

Evansville, Indiana Area

• Studied the effects of phyto-estrogen on rat offspring
• Educated younger students on colony breeding and rat care
• Developed coding methods and skills for data entry for the laboratory
• Deduced solutions for challenges that arose in the laboratory
• Resulted in a poster and publication in the National Conference for Undergraduate Research (NCUR) Proceedings

Evansville, Indiana Area

• Inspected the galvanic skin responses of cycling women to images
• Improved upon coding and data entry

Evansville, Indiana Area

• Examined adaptation to a visual perception shift
• Strengthened administrative skills in setting up testing
• Facilitated the learning of others testing procedures

Master’S Degree, Master'S Of Management In Health Care

The Vanderbilt Master of Management in Health Care is a graduate degree in management designed specifically to help rising managers in.

Bachelor Of Science (Bs), Neuroscience

Senior Thesis: "College Life Stressors & The Onset and Cycling of Bipolar Disorder" Explored the realms of bipolar disorder with respect.

Bachelor Of Science (B.S.), Psychology

Activities and Societies: Admission Ambassadors, Cognitive and Neural Science Research Group, Resident Students Association-Vice.

Neuroscience

Activities and Societies: Yearbook It was an enriching study abroad experience. I was able to expand international awareness in other.

High School, General Studies (Honors)

Activities and Societies: Yearbook, J.V Soccer, Student Government Association