Houston Methodist
Senior Regulatory Compliance Specialist
Houston Methodist, Houston, Texas, United States, 77246
Overview
At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position for Department of Medicine will also work with industry sponsors' or grant funder's regulatory personnel for study regulatory start up and study regulatory maintenance throughout the study. This position communicates closely with the study teams including research coordinators, clinical trial managers, and principal investigators, sponsor partners, IRB staff, and regulatory office staff. Attention to detail, ability to navigate multiple projects and good time management are important in the success of this position. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
Houston Methodist Standard
PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONSProvide 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 ModelDelivers personalized service using HM Service StandardsProvides 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 jobDisplays cultural humility, diversity, equity and inclusion principlesActively supports the organization's vision, fulfills the mission and abides by the I CARE valuesResponsibilities
PEOPLE ESSENTIAL FUNCTIONS
Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the departmentAssists 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 co-workersRole models behaviors that are congruent with cultural diversity, equity, and inclusion principles. Initiate's improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountabilitySERVICE ESSENTIAL FUNCTIONS
Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable resultsPrepare 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 closuresInterfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDADevelops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance ManagerQUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, 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 issuesConducts internal reviews and audits to ensure compliance of regulatory forms and associated documentationServes 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 requestedFINANCE ESSENTIAL FUNCTIONS
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as neededGROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications
EDUCATION
Bachelor's degree or higherMaster's degree preferredWORK EXPERIENCE
Five years of experience in relevant research program experienceLicense/Certification
LICENSES AND CERTIFICATIONS - REQUIRED
RAC - Regulatory Affairs Certifications (RAPS)
ORCCRC - Certified Clinical Research Coordinator (ACRP)
ORCCRP - Certified Clinical Research Professional (SOCRA)KSA/ Supplemental Data
KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient 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 securityAbility to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principlesDemonstrates 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 improvementAbility to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processesAbility to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievementAbility to work independently and interdependentlyStrong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical qualitySUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform NoScrubs NoBusiness professional YesOther (department approved) NoON-CALL**Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
On Call* NoTRAVEL****Travel specifications may vary by department**
May require travel within the Houston Metropolitan area NoMay require travel outside Houston Metropolitan area No
Company Profile
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 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH). This position for Department of Medicine will also work with industry sponsors' or grant funder's regulatory personnel for study regulatory start up and study regulatory maintenance throughout the study. This position communicates closely with the study teams including research coordinators, clinical trial managers, and principal investigators, sponsor partners, IRB staff, and regulatory office staff. Attention to detail, ability to navigate multiple projects and good time management are important in the success of this position. The Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.
Houston Methodist Standard
PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONSProvide 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 ModelDelivers personalized service using HM Service StandardsProvides 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 jobDisplays cultural humility, diversity, equity and inclusion principlesActively supports the organization's vision, fulfills the mission and abides by the I CARE valuesResponsibilities
PEOPLE ESSENTIAL FUNCTIONS
Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the departmentAssists 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 co-workersRole models behaviors that are congruent with cultural diversity, equity, and inclusion principles. Initiate's improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountabilitySERVICE ESSENTIAL FUNCTIONS
Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable resultsPrepare 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 closuresInterfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDADevelops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance ManagerQUALITY/SAFETY ESSENTIAL FUNCTIONS
Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, 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 issuesConducts internal reviews and audits to ensure compliance of regulatory forms and associated documentationServes 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 requestedFINANCE ESSENTIAL FUNCTIONS
Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as neededGROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications
EDUCATION
Bachelor's degree or higherMaster's degree preferredWORK EXPERIENCE
Five years of experience in relevant research program experienceLicense/Certification
LICENSES AND CERTIFICATIONS - REQUIRED
RAC - Regulatory Affairs Certifications (RAPS)
ORCCRC - Certified Clinical Research Coordinator (ACRP)
ORCCRP - Certified Clinical Research Professional (SOCRA)KSA/ Supplemental Data
KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationsSufficient 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 securityAbility to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principlesDemonstrates 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 improvementAbility to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processesAbility to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievementAbility to work independently and interdependentlyStrong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical qualitySUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform NoScrubs NoBusiness professional YesOther (department approved) NoON-CALL**Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
On Call* NoTRAVEL****Travel specifications may vary by department**
May require travel within the Houston Metropolitan area NoMay require travel outside Houston Metropolitan area No
Company Profile
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 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.