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.▪ Works with the Global Proposal Management team to ensure that new project proposals are accurate, descriptive, and appropriate as it relates to Clinical Operations items▪ Coordinates with appropriate cross-functional departments to facilitate negotiation/ issue resolution for clinical trial related issues▪ Identifies and develops problem-solving strategies to address issues▪ Meets regularly with direct reports, assists with their professional development, and conducts their annual reviews▪ Assists with the selection and interviewing of potential employees and makes hiring recommendations.▪ Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company SOPs▪ Participates in internal, client/sponsor, scientific, bid defense and other meetings.

▪ 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▪ Responsible for invoicing: external vendors, CROs, staff burndowns, licensing and other operational elements as well as the associated forecasting▪ Identified potential study risks and developed mitigation strategies-Proactive vs. reactive mindset▪ Participated in development and review of departmental SOPs, guidelines, intra/inter-departmental procedures, and other continuous process improvements programs▪ Served as the subject matter expert in internal and external meetings-primary sponsor contact▪ Mentored junior team members▪ Completed regulatory submissions (US & Canada)▪ Lead a cross-functional team through start-up to close out▪ Facilitated SIVs, Monitoring visits, KOM and other key study meetingsTherapeutic Areas: Dermatology—Atopic Dermatitis, Psoriasis, Hidradenitis Suppurativa & CNS—Parkinson’s Disease (PD); CVS–Atrial Fibrillation

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 (FA), Frontotemporal dementia (FTD); Rare Disease—Metachromatic Leukodystrophy (MLD), Gaucher’s Disease (Pediatric)

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• Lead international monthly status update meetings• Prepared and submitted IRB documents (amendments, continuing reviews, deviations, etc.)• Generated, reviewed and closed queries for study data • Supported affiliate staff with protocol and data needs • Developed source documents for data capture in electronic database (REDCap)• Coordinated patient recruitment across multiple studies• Exceeded site recruitment commitments • Reported safety issues to IRB• Extracted key details from data sets to analyze and tailor research recruitment• Overhauled site SOPs• Troubleshot problems with team members and suggested solutions• Created reports and analytics for determining study progress• Supervised training of new staff• Maintained inventory of intervention devices• Reviewed databases for errors and inconsistencies between systemsTherapeutic Area: Oncology (Breast, Head & Neck); Lymphedema

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• Generated and amended study documents• Devised recruitment strategies for upcoming studies• Supervised training of new staff• Presented status updates during international teleconferencing• Registered study participants into OnCore• Harmonized staff scheduling to ensure appropriate coverage of tasks• Improved work flow by eliminating superfluous steps• Reviewed databases for errors and inconsistencies• Validated manuscript content prior to publication submission• Reconciled data routinely into a central data source• Facilitated open communication • Obtained additional education and credentials as pertains to Lymphedema• Patient interaction via survey administration, data collection and data analysis• Accurate data entry of event files in study databasesTherapeutic Area: Lymphedema, Device (Bioimpedance spectroscopy (BIS))

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 • Spearheaded multiple community outreach eventsTherapeutic Area: Multispecialty— Dermatology (Acne), Neurology (Alzheimer’s Disease | Migraines | Pain), Psychiatry (Depression | Binge Eating), Endocrinology (High Cholesterol | Weight Loss), Cardiovascular (Hypertension), Women’s Health (Birth control | Female Orgasmic Disorder | Endometriosis), Substance Abuse (Smoking Cessation), Men’s Health (Low T), Vaccine (Flu | RSV | Meningitis| HPV | Shingles), Medical Device (Flu Assays, Glucose Meters)

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• Verified account information by telephoning practicesTherapeutic Area: Nephrology

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• Solved queries for chart accuracy and audits

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.

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