ObjectiveHealth

● Providing direct operational support for sites by ensuring site accountability to meet and exceed established study goals and data quality expectations.
● Building (three and counting) new research Centers of Excellence to bring clinical research to new markets.
● Cultivating consistent site visit volume and revenue month over month across assigned sites and achieving 100% growth in site visit volume from Jan 2022 to Dec 2023 across assigned sites.
● Subject matter expert for multiple study protocols executed network-wide; serving as trial manager to meet contracted goals with multiple sponsors and associated vendors.
● Auditing sites' data collection to ensure internal standards & ALCOA-C standards are consistently applied.
● Identifying site-specific improvement needs, and spearheading corrective action plans as required.
● Facilitating leadership growth by empowering site directors to mentor and build teams, leading to nearly 100% employee retention.
● Collaborated with Training Department to develop and improve site staff competency assessment for employee development & advancement.
● Nurturing established relationships with physicians by providing a direct operational presence with the joint venture practice.

Senior Director of Clinical Operations

● Provided direct operational support for assigned sites while ensuring accountability to meet and exceed established goals and expectations.
● Ensured assigned sites are managing and executing all clinical trials at, or above sponsor requirements. 
● Conducted site visits to ensure compliance with company processes and procedures.
● Mentored four new clinical operations directors as the company continues to grow.
● Identified individual site improvement needs, and developed best practice plans as required.
● Provided oversight and support for implementation of Complion eTMF networkwide.
● Nurtured established relationships with assigned sites, and providing a direct presence with the joint venture practice.
● Achieved nine consecutive months of profitability at my assigned sites.

Regional Director of Clinical Operations

●  Provided direct support for assigned sites, ensuring accountability to goals and expectations.
●  Ensured assigned sites are managing and executing all clinical trials at, or above sponsor expectations.  
●  Conducted site visits to ensure site staff compliance with company processes and procedures.
● Identified areas of improvement, and created and implemented improvement plans as necessary.
●  Maintained established relationships and communication with assigned sites, and provided a direct presence with the joint venture practice.

Associate Director of Clinical Operations

Meridian Clinical Research

●  Conduct assigned high-enrolling, vaccine-focused research studies according to protocol specifications while adhering to ICH/GCP and regulatory guidelines.
●  Work with study sponsors and CROs to ensure highest quality of data collection on-site while meeting accelerated timelines for enrollment and data analysis. 
●  Overseeing all non-clinical aspects of assigned trials including study start-up, regulatory, EDC entry, query resolution, and study closeout.
●  Perform required study assessments as required per protocol. 
●  Provide mentorship and guidance to new research coordinators and research staff per the Learning and Development curriculum. 
●  Assess competencies and performance metrics as set forth to measure new employee progress and success.

Lead Clinical Research Coordinator

●  Provided on-site leadership and overseeing clinical operations for primarily Phase 2-3 clinical research studies. 
●  Responsible for managing and executing clinical trials, mentoring staff, improving clinical processes, and ensuring all sponsor expectations are met and/or exceeded. 
● First site nationwide to enroll a subject into the first Phase 2, SARS-COV-2 trial. 
●  Expanded and retained new staff to meet site study enrollment expectations without sacrificing quality production, due to continuing success of ongoing clinical vaccine trials. 
●  Completed all pre-site visits with sponsors to determine site’s ability to successfully complete protocols.

Site Director

The Asthma & Allergy Center, PC

●	Conduct assigned research studies according to protocol specifications while adhering to ICH/GCP and regulatory guidelines.
●	Work with study sponsors and CROs to ensure highest quality of data collection on-site. 
●	Overseeing all non-clinical aspects of assigned trials including study start-up, regulatory, EDC entry, query resolution, and study closeout.
●	Perform required study assessments including vital signs, EKGs, spirometry, phlebotomy, and medication dispensation.
●	Review all incoming study protocols to determine study completion feasibility to meet site recruitment goals.

Clinical Research Coordinator

Quality Clinical Research

●	Conducted research studies according to assigned protocol while adhering to ICH/GCP and regulatory guidelines.
●	Developed and implemented phlebotomy training and competency program for qualified staff.
●	Responsible for all non-clinical aspects of assigned trials including regulatory, query resolution, and study close out. 
●	Performed required study assessments including vital signs, EKGs, phlebotomy, and medication dispensation.
●	Reviewed incoming study protocols to determine study completion feasibility.

Children's Hospital & Medical Center - Omaha

●	Collaborated with management developing a process to maintain adequate supply of surgical pumps to operating suites.
●	Ensured operating room anesthesia machines were calibrated and ready for each surgical case.
●	Provided phlebotomy support for surgical cases as necessary.
●	Assisted with training of new Anesthesia Technicians and providing feedback to hospital educational team.

Anesthesia Technician & Phlebotomist

University of Nebraska Medical Center

●	Coordinator of record for several studies in patient follow-up stages.
●	Worked with and maintained security of confidential patient records, including electronic health records.
●	Assisted in general clinic administration including first point of contact, scheduling, creation of documents, stipend remittance, and S.O.P. reviews.
●	Successfully collaborated with other hospital departments to provide superior service to both patients and staff.
●	Actively improved shipping and ordering processes within the department to provide evolving services as needed. 
●	Continued in all duties of my previous position, Clinical Research Assistant II.

Clinical Study Associate

Nebraska Medicine

●	Responsible for sample collection, processing, and shipping of all required specimens, as well as EKGs and other tests.
●	Collaborated with clinical nurse coordinators to ensure trials were run according to protocol specifications.
●	Ensured all equipment was calibrated and properly maintained by in-house service team.
●	Utilized various sponsor software and equipment to collect the high quality data for research studies.
●	Entered collected study data into various electronic case report forms and responding to data queries as appropriate.
●	Trained or refreshed all incoming clinical research staff on sample processing and phlebotomy as necessary.

Clinical Research Assistant II

MDS Pharma Services

●	Primary specialist on over 40 separate clinical studies.
●	Worked with study sponsors to ensure trials were run according to protocol specifications from start to close out. 
●	Collected, processed, and shipped clinical specimens to sponsors following study completion. 
●	Responsible for the setup and flow of clinical conduct for studies and ensured quality control of data. 
●	Ordered appropriate equipment for research studies and ensuring it was ready for clinic use.

Clinical Conduct Specialist

●	Supervisory position with decision-making authority over 50 employees and responsible for ensuring all clinical conduct was performed according to internal training plans and SOPs. 
●	Responsible for revision of Clinical Conduct Officer training plan under which all qualified associates were trained. 
●	Provided personnel input to staff managers on advanced training for qualified associates. 
●	Oversaw all training of new Clinical Conduct Officers. 
●	Assisted in training of new phlebotomists in our in-house training program.
●	Continued in all duties of my previous position, Clinical Service Technician.

Clinical Conduct Team Leader

●	Conducted clinical events including Vital Signs, Electrocardiograms, Phlebotomy, Dispensing Test Compounds, and Sample Processing.
●	Monitored clinical unit, employee clock-in and clock-out times, breaks, and ensured staff was utilized efficiently.
●	Assisted in training and mentoring of new employees.
●	Responsible for reworking staff schedules due to absences.
●	Provided excellent customer service to study participant requests, and staff.

Clinical Service Technician

●	Part-time position responsible for clinical events including Vital Signs, Sample Processing, and customer service.

Clinical Conduct Associate

Bigler Motors

• Provided fantastic customer service as the first point of contact for customers contacting dealership and directing calls as necessary.
• Greeted customers on the lot, often providing first point of contact representative of the dealership.
• Photographed and upload photos of inventory to sales websites.
• Handled vehicle title inspections and follow up with mechanical inspections as necessary.
• Responsible for taking cash and check deposits to bank as required.

Office and Internet Manager

As the Senior Director of Clinical Operations at ObjectiveHealth, I lead and support a network of sites that conduct clinical trials across various therapeutic areas and phases. With nearly 20 years of clinical research experience in all phases and multiple indications, I have developed a strong foundation of quality, efficiency, and teamwork, that enables me to deliver successful outcomes for our sponsors and patients.

I am passionate about building and retaining amazing teams, improving processes, and increasing success, and providing innovative leadership in a dynamic and fast-paced industry. I have spearheaded the creation of three new research Centers of Excellence, achieved 100% growth in site visit volume from 2022 to 2023, and continually audit sites' data collection quality to ensure compliance with internal and external standards. 

During my tenure as Site Director during the COVID-19 pandemic, our site grew from 10 FTE to 27 FTE (with 93% retention) due to study mix, volume, and accelerated study timelines. Our site in northeast Nebraska was the first site to successfully enroll a patient into the first Phase 2, mRNA, SARS-COV-2 vaccine trial in the country.

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