Sr Regulatory Compliance Specialist

Houston Methodist•Houston, TX

About The Position

FLSA STATUS Exempt QUALIFICATIONS EDUCATION Bachelor’s degree or higher Master’s degree preferred EXPERIENCE Five years of experience in relevant research program experience LICENSES AND CERTIFICATIONS Required Must have one of the following certifications: RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA) SKILLS AND ABILITIES Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going 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 co-workers 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 ESSENTIAL FUNCTIONS 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 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 co-workers Initiate’s improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability SERVICE 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 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 QUALITY/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 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 FINANCE 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 needed GROWTH/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. SUPPLEMENTAL REQUIREMENTS WORK ATTIRE Uniform: No Scrubs: No Business professional: Yes Other (department approved): No ON-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 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

Requirements

Bachelor’s degree or higher
Five years of experience in relevant research program experience
Must have one of the following certifications: 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 on-going 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 co-workers 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

Nice To Haves

Master’s degree preferred

Responsibilities

Collaborates with cross-functional teams including key study personnel.
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
Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership.
Initiate’s improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability
Serves as subject matter expert in support of department functions.
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 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 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.
Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
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.