Sr Regulatory Compliance Specialist

HOUSTON METHODIST EXPERIENCE EXPECTATIONS

• Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional ethical physical and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth dignity and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET Managing Up Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees experiential journeys to ensure strong communication ease of access to information and a seamless experience

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Actively supports the organizations vision fulfills the mission and abides by the I CARE values

• Collaborates with crossfunctional teams including key study personnel. Role models strong positive communication skills to ensure cohesive smooth operation of the department

• Assists in training regulatory personnel and others on regulatory and safety reporting regulations processes and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)

• Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies Sponsors vendors patients and coworkers

• Initiates improvement recommendations for department scores for employee engagement i.e. peertopeer accountability

• Serves as subject matter expert in support of department functions. Defines problems collects data establishes facts and draws valid conclusions and evidencebased performance improvement via measurable results

• Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB submission submits protocol amendments prepares renewals and necessary regulatory documents for submission to study sponsors. Submits adverse event reports safety reports and notifies IRB of study closures

• Interfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA

• Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager

• Ensures compliance of general and studyspecific regulatory and/or safetyrelated processes with SOPs FDA GCP NIH and applicable regulations. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues

• Conducts internal reviews and audits to ensure compliance of regulatory forms and associated documentation

• Serves as a liaison between the institutional review committees regulatory agencies and the investigators to ensure that protocols are approved and that supplementary information is provided in a timely fashion as requested

• Utilizes resources with cost effectiveness and value creation in mind. Selfmotivated to independently manage time effectively and prioritize daily tasks assisting coworkers as needed

• Seeks opportunities to identify selfdevelopment needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an ongoing basis.

• Bachelors degree or higher

• Masters degree preferred

• Five years of experience in relevant research program experience

• RAC Regulatory Affairs Certifications (RAPS) OR
• CCRC Certified Clinical Research Coordinator (ACRP) OR
• CCRP Certified Clinical Research Professional (SOCRA)

• Demonstrates the skills and competencies necessary to safely perform the assigned job determined through ongoing skills competency assessments and performance evaluations

• Sufficient proficiency in speaking reading and writing the English language necessary to perform the essential functions of this job especially with regard to activities impacting patient or employee safety or security

• Ability to effectively communicate with patients physicians family members and coworkers in a manner consistent with a customer service focus and application of positive language principles

• Demonstrates expert knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)

• Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement

• Ability to enter and abstract data using personal computer as well as the ability to utilize data to facilitate the improvement and change in processes

• Ability to facilitate performance improvement teams present data and promote a collaborative approach toward goal achievement

• Ability to work independently and interdependently

• Strong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality

SUPPLEMENTAL REQUIREMENTS

WORK ATTIRE

• Uniform No
• Scrubs No
• Business professional Yes
• Other (department approved) No

ONCALL*
*Note that employees may be required to be oncall during emergencies (ie. DIsaster Severe Weather Events etc) regardless of selection below.

• On Call* No

TRAVEL**
**Travel specifications may vary by department**

• May require travel within the Houston Metropolitan area No
• May require travel outside Houston Metropolitan area No

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540000 square foot building dedicated to research the research institute houses over 1500 staff and trainees 284 principal investigators and has more than 570 ongoing clinical trials.