Refer 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 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 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 values Responsibilities 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 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 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 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 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 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 FUNCTIONSSeeks 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 preferred
WORK EXPERIENCE
Five years of experience in relevant research program experience License/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 quality
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform NoScrubs NoBusiness professional YesOther (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 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.
Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Need help finding the right job? We can recommend jobs specifically for you! Click here to get started.Equal Employment Opportunity
Houston Methodist is an Equal Opportunity Employer.
Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law. VEVRAA Federal Contractor – priority referral Protected Veterans requested. Application FAQs
Software Powered by iCIMS
www.icims.com