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Work Background
ObjectiveHealthSenior Director of Clinical Operations
Feb. 2023 - Aug. 2024Franklin, Tennessee, United States● Providing direct operational support for sites by ensuring site accountability to meet and exceed established study goals and data quality requirements.
● Building (three and counting) and developing new research Centers of Excellence to bring clinical research to new markets.
● Driving 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 a Clinical 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.
ObjectiveHealthRegional Director of Clinical Operations
Jul. 2022 - Feb. 2023Franklin, TN● 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.
ObjectiveHealthAssociate Director of Clinical Operations
Feb. 2022 - Jul. 2022● Provided direct support for assigned sites, ensuring accountability to goals and expectations.
● Implemented network-wide usage of HIPAA-compliant ride-sharing program to provide study patients with transportation to/from research sites as needed.
● 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.
Meridian Clinical ResearchLead Clinical Research Coordinator
Jun. 2021 - Mar. 2022Omaha, Nebraska, United States● 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.
Meridian Clinical ResearchSite Director
Mar. 2020 - May. 2021Norfolk, Nebraska, United States● 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.
The Asthma & Allergy Center, PCClinical Research Coordinator
May. 2018 - Mar. 2020Bellevue, Nebraska● 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.
Quality Clinical ResearchClinical Research Coordinator
Jan. 2017 - May. 2018Omaha, Nebraska● 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 - OmahaAnesthesia Technician & Phlebotomist
Mar. 2016 - Jan. 2017Omaha, Nebraska● 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.
University of Nebraska Medical CenterClinical Study Associate
Dec. 2014 - Mar. 2016Omaha● 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.
Nebraska MedicineClinical Research Assistant II
Apr. 2010 - Dec. 2014● 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 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.
MDS Pharma ServicesClinical Conduct Specialist
Jul. 2007 - Mar. 2010Lincoln, Nebraska● 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.
MDS Pharma ServicesClinical Conduct Team Leader
Oct. 2006 - Jul. 2007Lincoln, Nebraska● 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.
MDS Pharma ServicesClinical Service Technician
May. 2005 - Oct. 2006Lincoln, Nebraska● 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.
MDS Pharma ServicesClinical Conduct Associate
Nov. 2004 - May. 2005Lincoln, Nebraska● Part-time position responsible for clinical events including Vital Signs, Sample Processing, and data collection.
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