Job Description

Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a diverse healthcare legacy that’s served our community for more than 125 years. Put your skills to work with us, seek opportunities to learn and join a talented team where patient care is more than a job. It’s our passion.

Primary Purpose
Directs the Parkland Research Compliance Program and the Enterprise Research Risk Assessment. Aligns with and supports the goals and directives of the Parkland Corporate Compliance Office and other Parkland Departments charged with compliance responsibilities. Develops and implements research compliance operations including routine and for cause audits, investigations, root cause analysis and corrective action, training, and regulatory-directed programs. Reports to senior leadership at Parkland and affiliated organizations. 

Minimum Specifications
 

Education

• Must have a Master’s degree in a clinical field, Healthcare Administration, Business Administration, Healthcare or Research Compliance or a related field.
• Must have a Bachelor’s degree in Nursing.
   

Experience

• Must have twelve (12) years of experience working with clinical research, healthcare regulation, compliance and/or risk management.
• Must have eight (8) years of clinical nursing experience.
• Must have eight (8) years or more of supervisory experience.
   

Equivalent Education and/or Experience

• May have an equivalent combination of education and experience to substitute for the education and experience requirements.

Certification/Registration/Licensure

• Must have Federal Emergency Management Administration (FEMA) course certification for IS-700.B: An Introduction to the National Incident Management System (NIMS) or obtain within 30 days of placement in role.
• Must have Federal Emergency Management Administration (FEMA) course certification for IS-100.C: Introduction to the Incident Command System (ICS 100) for Healthcare/Hospitals or obtain within 30 days of placement in role.
• Must have Federal Emergency Management Administration (FEMA) course certification for IS-200.HCA: Applying ICS to Healthcare Organizations (ICS 200) or obtain within 30 days of placement in role.
• Must be certified in Health Care Research Compliance (CHRC) issued by the Health Care Compliance Association.
• Prefer certification in Healthcare Risk Management (CPHRM).
• Must have an active license from the Texas Board of Nursing.
• Certification in Healthcare Risk Management helpful.
   

Required Tests for Placement
 

Skills or Special Abilities

• Strong analytic, organizational and management skills to address complex and multi-organizational challenges. Must be able to organize, plan, and implement processes and resources that may involve multiple managers and leaders within Parkland and affiliated organizations.
• Mastery knowledge of laws and regulations governing clinical and data-driven research, including human subjects protection, HIPAA, research misconduct, conflict of interest, Good Clinical Practices, and research billing.
• Mastery knowledge of regulatory (FDA, DHHS, CMS, OIG, HIPAA) and Joint Commission standards relevant to patient care and research within the health care system.
• High level knowledge and experience working with and responding to federal and state agencies.
• Mastery level knowledge and experience in areas of patient safety, hospital operations, institutional compliance, institutional audit activities, and risk management and the relationship with research.
• Strong familiarity and experience evaluating research protocols, methodology, terminology, protocol design, Investigational New Drug requirements, Investigational Device requirements, research sponsor requirements and protocol support documents.
• Excellent analytic, problem solving, and decision-making skills and a demonstrated track record of addressing sensitive and difficult topics in a politically challenging environment.
• Strong interpersonal, communication and leadership skills to lead change and drive performance improvement.
• Demonstrated ability to analyze complex situations and be able to independently make sound decisions, corrective action plans, recommendations and operational changes to mitigate harm to patients and the institution.
• Mastery level knowledge of institutional engagement in research, leading the determination process and working with Parkland departments to facilitate these processes.  
• Demonstrated ability to educate and coach individuals and groups regarding laws and regulations affecting healthcare and research.
• Ability to develop and carry out a monitoring/auditing program including the development of audit tools and processes, sampling plan, reports and communications.
• Experience developing policies, procedures and training.
• Must be able to compile and analyze data related to monitoring activities.
• Experience creating and carrying out health or research-related training programs.
• Must be able to demonstrate computer skills to input and extract information using word processing, spread sheet, and data base software.
• Must be able to effectively communicate, both orally and in writing.
• Must be able to demonstrate effective organizational, time-management and problem-solving skills.
• Must be able to demonstrate effective management skills and techniques.
• Must be able to employ effective problem solving and effective interpersonal skills.
• Must be able to demonstrate patient-centered / patient-valued behaviors.
• Prefer a thorough knowledge with patient care research activities.
   

Responsibilities

1. Establishes and directs the Parkland Research Compliance Program in collaboration with the Vice President of Research and in support of the institutional compliance plan.
2. Promotes and directs activities that identify measure and support research compliance.
3. Develops a risk-based monitoring plan and designs appropriate monitoring activities and tools to address areas of compliance risks and needs. Provides findings from monitoring and auditing activities to the Vice President of Research and those committees as structured in the reporting chain to leadership.
4. Evaluates and advises the Office of Research Administration on DHHS, CMS, FDA, JC and OIG regulations and activities. As required, recommends revisions to processes and procedures for research conducted at Parkland to facilitate compliance.
5. Evaluates and advises the Office of Research Administration on hospital policies and procedures that impact research processes, the safety of research participants and compliance with regulations. As required, recommends revisions to research processes and procedures to meet new organizational policies and procedures.
6. Develops, implements, and coordinates presentations and training through various venues.
7. Investigates reports of serious non-compliance, continuing non-compliance and research participant safety events. Consultant to coordinate and ensures reports are submitted through the Parkland Safety Center and other venues in accordance with Parkland policies and procedures. Ensures corrective action plans are developed and implemented when indicated.
8. Develops and implements processes to assess the safety of patients participating in clinical trials at Parkland.
9. Review and report research misconduct, conflict of interest or privacy breach to the Vice President of Research and applicable committees as indicated.
10. Makes recommendations and participates in root cause analyses and corrective action plans.
11. Collects, analyzes and synthesizes data for the purpose of preparing periodic reports to the Vice President of Research, Corporate Compliance, department leaders and Parkland senior leadership.
12. Maintains a collaborative working relationship with the UTSW IRB and research compliance staff for coordination of activities to promote compliance adherence by UTSW faculty researchers.
13. Participates in campus-wide education and compliance initiatives in cooperation with Children’s Medical Center, UTSW, University Hospitals, Scottish Rite Hospital for Children and other regional collaborating institutions.
14. Leads the Research Compliance Risk Assessment process, develops mitigation strategies and action plans, monitors progress and reports to appropriate committees.
15. Oversees processes and tools for performance site review of research data requests.
     

Job Accountabilities

1. Identifies and analyzes the design of jobs, work processes, work flows, etc. for the area and implements appropriate changes to improve effectiveness, productivity, and efficiency that support the overall goals of the department and Parkland.
2. Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.
3. Maintains knowledge of applicable rules, regulations, policies, laws and guidelines that impact the area. Develops effective internal controls designed to promote adherence with applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.
4. Develops and monitors annual budgets that ensure the department has the necessary funds to carry out the goals and objectives that have been established for the department.
5. Develops, implements, monitors, and revises annual goals and objectives for the department that support the missions and objectives of Parkland.
6. Selects, trains, schedules, motivates, supervises, and evaluates employees making recommendations for disciplinary actions up to and including termination, to ensure maximum utilization of individual and group capabilities. Ensures that assigned employees receive opportunities to further their knowledge.

Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status.