• Assists Chief of Compliance, Chief of Security, and the EU Data Protection Officer with compliance program development and monitoring activities across all service lines, both domestically and internationally.
• Proficient in navigating and interpreting complex regulatory frameworks such as GDPR, OIG, AML, and HIPAA.
• Provides data needed to integrate compliance into business plans, scorecards, and processes, while removing barriers to implementation.
• Builds reporting solutions and develops/enhances existing dashboards and other key reports that are to be utilized by Senior Leadership to monitor program and communication effectiveness to Nordic's leadership team.
• Responds to privacy and security occurrences and breaches by investigating incidents and providing recommendations and appropriate disciplinary steps and sanctions, as needed.
• Utilize data analysis tools to monitor and analyze compliance metrics and trends.
• Oversees and conducts audits within various business

• Provided leadership and continual optimization of Premier, Inc. Clinical Trial Innovation and Real-world Evidence design and resources, optimization of key processes, team management, overall operating management, and oversight on all studies, while adhering to ICH GCP principles, GRC, HIPAA, and other regulatory requirements.
• Responsible for developing and maintaining project start-up plans, including but not limited to, clinical operations, recruitment, and retention strategy plans, etc. to be incorporated into the overall integrated study management plan.
• Contributed to the development and enhancement of compliance policies and procedures, while ensuring compliance with healthcare data privacy and security requirements.
• Collaborated with external site staff to develop and implement quality improvement initiatives for program objectives.
• Monitored clinical progress against contracts and prepared/presented project information proactively to all stakeholders internally an

• Served as senior leadership and principal investigator in managing a $1.5 million-dollar grant awarded by the Centers for Disease Control and Prevention (CDC) for expanding access to community resources through applied research, clinical partnerships, and community engagement.
• Utilized knowledge of ICH guidelines, Good Clinical Practices, HIPAA and other applicable regulations and guidelines to safeguard community survey participants and business partner responses to ensure data protection, compliance, integrity, and security.
• Initiated and set goals for programs according to the strategic objectives of the organization.
• Oversaw all program and project deliverables involved to provide feedback and resolve complex problems, while applying change, risk and resource management principles
• Ensured program operations, procurement activities, and strategy initiatives adhere to legal guidelines and internal policies.

• Managed all components of clinical trials from protocol inception through study closeout completion; including but not limited to staffing; implementing protocols; site selection; monitoring plans and training site staff, internal staff and monitors on protocol specific procedures.
• Upheld the protection of all research participants by applying the concepts of privacy, confidentiality and anonymity to ensure participants' rights were upheld to the highest standard.
• Functioned as the public facing patient/provider liaison in managing the workflow of clinical team members to maximize effort coverage for the Methodist Health System Clinical Research Institute (MHSCRI).
• Developed partnerships and collaborated with corporate, community organizations, civic groups, and other external partners ensuring clinical trials and study related activities were conducted according to governing regulatory agencies and guidelines that maximized human research protection through trial participat

• Served as lead clinical research project coordinator in the development, coordination, and reviews of clinical research study procedures to ensure receipt, completeness, and accuracy of research data required for studies.
• Managed all regulatory aspects of phases II, III, and IV clinical trial research studies such as: preparing safety reports, adverse events, FDA compliance, Drug Company monitoring, and laboratory standards.
• Served as primary liaison in preparing annual reports for federal, state, and/or local agencies
● • Coordinated collection and data management of national research studies from various projects by interacting with internal and external data managers, patients, and physicians for coordination of study samples, lab data and protocols, and other statistical information concerning research study subjects.
• Served as lead delegate in the development, negotiation, and monitoring of budgets, subject reimbursement rates, expenditure approvals, invoice payments,

• Provided direction on organizational compliance issues and enforced proper government and internal compliance regulation standards by ensuring adherence to the seven (7) data protection principles under the General Data Protection Regulation (GDPR).
• Conducted audits and analytical assessments to determine compliance with policies and procedures, federal regulations and federal and state laws as it related to technical safeguards to protect all electronic protected healthcare information (ePHI).
• Formulated recommendations based on audit findings, while providing written audit, assessment, and corrective action reports/plans. Worked closely with colleagues, where applicable, to determine implementation of effective corrective actions/sanctions.
• Responded to internal and external inquiries regarding compliance policies and guidelines. Provided advice and direction to constituents so operational and strategic business decisions were implemented in full compliance with GDPR regul

• Decreased compliance errors in high trend violation areas by 36%, by leading quality improvement initiatives in assisting with training all clinical nurse management in the Emergency Department, Surgical Intensive Care Unit, Women and Infant Specialty Health, and Medicine Services.
• Assisted in all activities related to the implementation of and compliance with Parkland policies, procedures and guidelines governing the privacy and confidentiality of all individually identifiable information in accordance with the Office of Inspector General of the U.S. Department of HHS, Office for Civil Rights, and other applicable rules, policies, laws and regulations (HIPAA, HITECH, GDPR, etc.) that impact employees, patient relations, and clinical research programs.
• Effectively built collaborative partnerships with all Parkland Human Resources and managing leadership staff to provide appropriate information, guidance, and disciplinary action regarding compliance, HIPAA, and other infractions

• Served as the inter-departmental clinical quality manager in providing comprehensive oversight for performance improvement (PI) initiatives within the HIV Services department and the COPC and Y&F clinic sites providing HIV care.
• Utilized the PDSA change model to perform gap analysis on quantitative performance information to identify potential weaknesses and areas for improvement and recommended solutions.
• Led recurring project team meetings with physicians, unit managers and support staff; project teams consisted of physicians, nurses, clinical research associates at UT Southwestern, etc., to develop and implement clinical measures, design complex data analysis tools, as well as analyze and organize data to facilitate targeted clinical interventions to improve patient care.
• Supported departmental programmatic functions by maintaining and evaluating data through processing, analysis, trending and tracking, while providing data and reports for additional statistical analysis

• Successfully managed the Quality Management Unit, comprised of 3 employees and a 30% operating budget of total departmental grant award funds within the Grants Management division, by assessing the compliance, quality of service, and performance outcomes of current health and social services delivery system for a 12-county area by analyzing and evaluating client health services for 14 service delivery agencies.
• Minimized potential risks to subject safety by ensuring any adverse events was reported and accurately documented.
• Improved services in local Dallas and Denton communities by devising clinical and administrative contingency assessment plans and evaluation reports to thoroughly depict areas of strengths, weaknesses, and best practices.
• Responsible for needs analysis, design, delivery, implementation, and evaluation of training and performance improvement program.
• Developed and composed narrative components and procurement required deliverables for request for propos

• Developed and implemented technical and programmatic work instructions for establishing a quality management program for ISO 9001:2000 accreditation.
• Evaluated the effectiveness and implementation of ongoing departmental process changes.
• Devised and executed operational policies and procedures for communicating with Centers for Medicare and Medicaid (CMS) and other federal entities for seamless program interface.
• Created data tracking tools for monitoring monthly ad hoc reporting trends to target benchmarks and make process improvements.
• Utilized project management and analytical skills to monitor expenditures to ensure budget compliance and adherence to corporate guidelines.