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clinical care coordinator - pedi cv surgery Jobs in Houston

clinical fellow speech-language pathologist (cfy) – pediatrics Jobs in Houston

clinical nurse coordinator Jobs in Houston

clinical nurse coordinator

clinical psychologist (behavioral health consultant) Jobs in Houston

home health nurse consultant & supervising nurse Jobs in Houston

clinical educator

Region 4 Education Service Center

<div><p><b>Title: </b>Regional Principal Development Coach
</p><p><b>Classification: </b>Admin/Prof
</p><p><b>Exemption Status/Test: </b>Exempt/Professional
</p><p><b>Job Grade: </b>3
</p><p><b>Department: </b>Educator Development
</p><p><b>Reports To: </b>Assistant Director<br>
</p><p></p><p><b>Job Goal:
</b></p><p>Improve and enhance principal certification candidates&rsquo; leadership skills and ability to navigate challenges through ongoing coaching and feedback. This position requires daily travel throughout the Region 4 area.<br>
</p><p></p><p><b>Qualifications:
</b></p><p><b>Education
</b></p><p>Master&rsquo;s degree<br>
</p><p></p><p><b>Certification
</b></p><div><ul><li>Texas teaching certificate
</li></ul>Principal or Mid-Management certificate<br>
<ul><li>
</li></ul></div><p></p><p><b>Experience
</b></p><div><ul><li>One year of experience as an assistant principal or principal in a traditional district/charter school
</li></ul>Experience in mentoring or coaching school leaders to enhance their leadership effectiveness<br>
<ul><li>
</li></ul></div><p></p><p><b>Special Knowledge and Skills
</b></p><div><ul><li>Exemplary written and oral communication skills as demonstrated in an ability to write reports.
</li></ul><ul><li>Ability to effectively present information and respond to questions from Region 4 Education Service Center (ESC) leadership, candidates, and other stakeholders.
</li></ul></div><p><b>Preferred Qualifications:
</b></p>Experience with the Accountability System for Educator Preparation (ASEP) and performance-based assessments such as the Performance Assessment for School Leaders (PASL)<br>
<ul><li>
</li></ul><p></p><p><b>Major Responsibilities </b>:<br>
</p><p></p><div><ul><li>Lead Educator Development efforts to implement PASL in the principal certification program practicum. Assist with data collection, reporting, and analysis concerning PASL and consequential implementation of performance-based assessments as directed by the TEA.
</li></ul><ul><li>Work with the Regional Coordinator II - Advanced Certification Support in the advanced certification program, the Educator Certification Specialist, and district personnel to support aspiring principals&rsquo; success in the practicum and on performance-based assessments (PASL) conducted in the field.
</li></ul><ul><li>Serve as the primary point of contact for principal certification candidates, mentors, and school based administrators. Maintain current knowledge of state certification regulations and ensure program compliance with TAC in all aspects of the practicum and performance-based assessments such as PASL.
</li></ul><ul><li>Anticipate and address field-based issues with high responsiveness and follow through.
</li></ul><ul><li>Execute the program practicum component, including candidate support and field supervision in compliance with TAC, and communication with participating school systems.
</li></ul><ul><li>Assist the Certification Specialist in executing the program approval of and standard certificates in compliance with TAC and program policy.
</li></ul><ul><li>Continuously and effectively communicate with program participants, course instructors, and staff regarding the importance and steps for completing all practicum requirements for becoming certified, including PASL.
</li></ul><ul><li>Support the advanced certification team in integrating PASL requirements into coursework.
</li></ul><ul><li>Support Region 4 policy and keep records for determining when a program participant is eligible to receive PASL approval. Manage permissions related to taking the PASL.
</li></ul><ul><li>Support program participants who still need to pass the PASL or receive any condition codes through coaching, tutoring, and resubmission. Manage the resubmission process.
</li></ul><ul><li>Communicate with the Certification Specialist to support PASL data management and compliance. Support PASL data gathering and analyses and be accountable for the success of program participants in performance assessments. Assist with reporting program performance data to the TEA and Region 4 ESC leadership.
</li></ul><ul><li>Maintain the Region 4 Education Service Center status, under the state accountability system for educator preparation programs, as &ldquo;Accredited&rdquo; through data reporting and compliance with program state and federal requirements.
</li></ul><ul><li>Engage in semi-annual program advisory committee meetings that ensure stakeholder participation and base support.
</li></ul><ul><li>Address program participants&rsquo; programmatic issues related to the principal certification practicum. Participate in information sessions.
</li></ul><ul><li>Assist with audits and compliance with local, state, and national standards.
</li></ul><ul><li>Engage in relevant professional development to maintain evidence-based practices in the principal certification program practicum.
</li></ul><ul><li>Provide technical assistance and services as specified by any applicable grant that directly or indirectly supports this position.
</li></ul></div><p><b>S </b><b>upervision/Personnel Management
</b></p><p>None<br>
</p><p></p><p><b>Physical Demands/Environmental Factors/Mental Demands:
</b></p><p>Frequent use of standard office equipment; prolonged sitting; occasional bending/stooping, pushing/pulling, and twisting; repetitive hand motions (keyboarding and use of mouse); occasional light lifting and carrying (less than 20 pounds); may work prolonged and irregular hours; occasional statewide travel; work with frequent interruptions; maintain emotional control under pressure.</p></div>

Regional Principal Development Coach

Memorial Hermann Health System

At Memorial Hermann, we pursue a common goal of delivering high quality, efficient care while creating exceptional experiences for every member of our community. When we say every member of our community, that includes our employees. We know that when our employees feel cared for, heard and valued, they are inspired to create moments that exceed expectations, while prioritizing safety, compassion, personalization and efficiency. If you want to advance your career and contribute to our vision of creating healthier communities, now and for generations to come, we want you to be a part of our team.
<br><br>
Job Summary
<br><br>
Position responsible for recommending and administering basic and advanced therapeutic and diagnostic procedures, including arterial blood gases, neonatal procedures, trauma care and ventilator transports, to patients with respiratory disorders, including patients in adult and neonatal critical care units. Functions as a resource to RCP I and RCP II’s. Participates and leads advanced patient education. Actively involved in departmental operations.* 2+ years Respiratory experience* High acuity experience in fast paced environment* RRT highly preferred
<br>Job Description
<br><br>
Minimum Qualifications
<br><b>Education:</b> Bachelor’s degree preferred.
<br><br>
<b>Licenses/Certifications:</b><br>
<ul>
<li>Certified Respiratory Therapist (CRT). Registered Respiratory Therapist (RRT) preferred.</li>
<li>Current Respiratory Care Practitioner License or Temporary Respiratory Care Practitioner License.</li>
<li>Basic Life Support Certification</li>
<li>Two (2) of the following are preferred: ACLS, PALS, NRP, CPFT, RPFT, RPSGT, Asthma Certified Educator, NRP Instructor, ACLS Instructor, PALS Instructor,or BLS Instructor.</li>
</ul>
<b>Experience / Knowledge / Skills:</b><br>
<ul>
<li>RCP I1 year</li>
<li>RCP II 1-3 years</li>
<li>RCP III 3-10 years</li>
<li>RCP IV 10 years</li>
<li>Two (2) years of critical care experience, preferred.</li>
<li>Effective oral and written communication skills.</li>
<li>The position requires occasional lifting and carrying of up to 50 pounds; prolonged standing; frequent walking, stooping and squatting.</li>
<li>The visual ability to monitor instruments, computers and equipment, recognize alphanumeric characters, distinguish colors and observe physical characteristics are essential to this position.</li>
</ul>
Principal Accountabilities
<br><br>
<ul>
<li>Performs duties in a manner to promote quality patient care and customer service, while promoting safety, cost efficiency and a commitment to quality care.</li>
<li>Performs respiratory care procedures: administer medical gases, medication, and aerosols for therapeutic and diagnostic purposes and provide patient education.</li>
<li>Follows written orders from physicians in administering drugs and medication to the cardiopulmonary system of patients, evaluate treatment provided and take appropriate action.</li>
<li>Performs patient assessment and basic interpretation of arterial blood gases, pulmonary function testing and chest x-rays as indicated in Skills Check Off list.</li>
<li>Provides expert respiratory advice and recommendations to physicians and other staff for population served.</li>
<li>Communicates effectively with professional colleagues. Manages time effectively. Documents appropriately in the medical records and completes other documentation duties accurately and efficiently according to policies and procedures.</li>
<li>Remains current in respiratory care through continuing education, participation in services, and review of journals. Assists in clinic education efforts for patients, staff, hospital, system and/or the community.</li>
<li>Ensures safe care to patients, staff and visitors; adheres to all Memorial Hermann policies, procedures, and standards within budgetary specifications including time management, supply management, productivity and quality of service.</li>
<li>Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency; supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor and resource to less experienced staff.</li>
<li>Demonstrates commitment to caring for every member of our community by creating compassionate and personalized experiences. Models Memorial Hermann’s service standards by providing safe, caring, personalized and efficient experiences to patients and colleagues.</li>
<li>Other duties as assigned.</li>
</ul>


Respiratory Therapist, Nights - Southwest

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The lab is seeking a postdoctoral researcher to collaborate on groundbreaking projects integrating patient-level data with artificial intelligence (AI) and machine learning (ML) methodologies. The position involves annotating clinical data, collaborating with AI/ML/NLP teams, developing algorithms, and generating insights to improve patient care. The Postdoctoral Associate will write manuscripts, present research findings locally and nationally, and contribute to advancing clinical informatics.</p><p></p><p><br>
Baylor College of Medicine typically follows similar to the NIH stipulated stipend guidelines for Postdoctoral Associates.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Collaborates on the development of AI/ML/NLP-driven solutions for healthcare challenges.</li><li>
Reads and interprets patient-level data to support the development of AI/ML/NLP algorithms for clinical applications.</li><li>
Annotates medical notes and datasets to facilitate training and validation of predictive models.</li><li>
Collaborates with data scientists, machine learning engineers, and clinical collaborators to design, implement, and validate innovative algorithms.</li><li>
Conducts exploratory data analysis to extract meaningful insights from complex datasets.</li><li>
Writes manuscripts and prepare presentations for local, national, and international conferences.</li><li>
Conducts literature reviews and maintains awareness of advancements in bioinformatics, AI, and clinical data analysis.</li><li>
Applies foundational knowledge of biostatistics and AI principles to inform study design and algorithm development.</li><li>
Tests, debugs, and validates models in partnership with technical and clinical teams.</li><li>
Ensures adherence to ethical guidelines for the use of patient data in research and development.</li><li>
Works closely with the Artificial Intelligence in Health Lab (AIH-Lab) and the BD-STEP program to advance clinical informatics research.</li><li>
Leverages clinical expertise to refine machine learning models, ensuring clinical relevance and accuracy.</li><li>
Collaborates on the integration of clinical datasets into broader health informatics systems.</li><li>
Provides expert annotations for training large language models (LLMs) and NLP algorithms, focusing on healthcare-specific use cases.</li><li>
Presents findings in department meetings and seminars and support grant writing and funding initiatives.</li><li>
Mentors trainees or junior team members in clinical informatics and research methods as needed.</li><li>
Performs other job-related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
MD or Ph.D. in Basic Science, Health Science, or a related field.</li><li>
No experience required.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
MD passionate about clinical bioinformatics and driving innovation in healthcare.</li><li>
Able to write manuscripts, present research findings locally and nationally, and contribute to advancing clinical informatics.</li><li>
Background in basics statics.</li><li>
Background in basics AI.</li></ul></div></div></div><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p><p></p><p><br>
Nature; PD; SN</p></div>

Postdoctoral Associate - Clinical Bioinformatics

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
A Postdoctoral Associate position is available in the Division of Vascular Surgery&rsquo;s Vascular Intelligence for Translational AI &amp; Learning (VITAL) Lab, Michael E. DeBakey Department of Surgery. The Postdoctoral Associate will focus on clinical data collection, data management, and imaging-based and clinical research in aortic disease. The Postdoctoral Associate must hold an MD or MD/PhD degree with clinical research experience, or a PhD degree in biomedical engineering, medical physics, computational science, or a related field with experience in vascular imaging research.</p><p>
The Postdoctoral Associate will receive training under the guidance of the Principal Investigators and collaborating investigators to conduct prospective or retrospective imaging-based and clinical research projects focused on aortic disease and complex endovascular aortic repairs. Responsibilities include protocol development, study design, data collection and analysis, interpretation of clinical and imaging findings, manuscript preparation, and presentation of research findings at scientific meetings. This position provides an excellent platform for career development and the opportunity to contribute to cutting-edge research in advanced endovascular aortic therapies within a collaborative, multidisciplinary research environment.</p><p></p><p><br>
Baylor College of Medicine typically follows similar to the NIH stipulated stipend guidelines for Postdoctoral Associates.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Participates in prospective and retrospective imaging-based and clinical research projects focused on aortic disease and complex endovascular aortic repair, including protocol development, study design, clinical data collection and management, and imaging data organization and analysis.</li><li>
Participates in vascular imaging research that includes CTA/DICOM image acquisition, interpretation, imaging-based outcome analysis, and AI- and digital twin-based research initiatives.</li><li>
Develops research protocols that includes IRB submissions and amendments.</li><li>
Contributes to coordinate multicenter clinical research studies.</li><li>
Works collaboratively and professionally within multidisciplinary teams.</li><li>
Performs data analysis and interpretation of clinical and imaging research findings.</li><li>
Prepares high-quality abstracts, manuscripts, presentations, scientific reports, and other academic materials for peer-reviewed publications and local, national, and international professional conferences.</li><li>
Contributes to scholarly and collaborative research activities.</li><li>
Completes assigned responsibilities accurately and efficiently.</li><li>
Maintains research documentation and data quality standards.</li><li>
Perform other job-duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
MD or Ph.D. in Basic Science, Health Science, or a related field.</li><li>
No experience required.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
MD or MD/PhD degree with clinical research experience, or a PhD degree in biomedical engineering, medical physics, computational science, or a related field with experience in vascular imaging research.</li><li>
Experience in clinical or imaging-based research.</li><li>
Familiarity with vascular imaging software, image post-processing, and AI/machine learning applications in clinical or imaging research is desirable.</li><li>
Demonstrates strong written and verbal communication skills, attention to detail, professionalism, and the ability to manage multiple research responsibilities in a timely and organized manner.</li></ul></div></div></div><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p><p></p><p><br>
Nature; PD; SN</p></div>

Postdoctoral Associate - Aortic Imaging & Clinical Research

Houston Methodist

<div>At Houston Methodist, the Research Coordinator II position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
<div><b>FLSA STATUS</b><br>
Exempt<br>
<br>
<b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Four years of research experience
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Preferred</b><ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) <b>or</b></li><li>
CCRP - Certified Clinical Research Professional (SOCRA)
</li></ul><br>
<b>SKILLS AND ABILITIES</b><ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
</li><li>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
</li><li>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
</li><li>Ability to work independently
</li><li>Capable of handling challenging/difficult situations
</li>Demonstrates sound judgment and executes above average analytical skills<br>
<li>
</li></ul><br>
<br>
<b>ESSENTIAL FUNCTIONS</b><br>
<br>
<b>PEOPLE ESSENTIAL FUNCTIONS</b><ul><li>
Under the direction of the Principal Investigator (PI), drafts various communications with the Sponsor and/or regulatory documents to be sent to the Sponsor.
</li><li>Identifies and recruits clinical research subjects and monitors enrollment goals.
</li><li>May conduct in-services to floor nurses/physicians; assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
</li><li>Teaches peers to critically think by verbally expressing rationale for decisions and follows up consistently. Uses peer-to-peer accountability towards improvement of department score for turnover/retention/employee engagement.
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Participates in the Principal Investigator (PI) meetings.
</li><li>Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation. Obtains Informed Consent from study participant and documents appropriately.
</li><li>Obtains vital signs and performs phlebotomy per training and competence; monitors participants&rsquo; labs and notifies the PI of laboratory findings.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Prepares Institutional Research Board (IRB) documents under the direction of the PI, assists with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval.
</li><li>Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process. Adheres to internal controls established for the department.
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Assists with the budget development and Medicare coverage analysis.
</li><li>Utilizes resources effectively and efficiently, demonstrating responsible financial stewardship. Manages own time effectively and prioritizes work to achieve maximum results in a timely manner.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Assists PI and/or research nurse in the planning and design of source documents for protocol.
</li><li>Assists in developing procedures for laboratory collection and storage.
</li><li>Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
</li>Proactively manages own professional development and completes My Development Plan.<br>
<li>
</li></ul><br>
<br>
<b>SUPPLEMENTAL REQUIREMENTS</b><br>
<ul><b>
WORK ATTIRE</b><li><ul><li>
Uniform: No
</li><li>Scrubs: Yes
</li><li>Business professional: No
</li><li>Other (department approved): Yes
</li></ul></li><br>
<b>ON-CALL*</b><br>
<li><ul><li><i>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</i></li></ul></li><li><ul><li>
On Call* No
</li></ul></li><br>
<b>TRAVEL**</b><br>
<i>**Travel specifications may vary by department**</i><li><ul><li>
May require travel within the Houston Metropolitan area No
</li><li>May require travel outside Houston Metropolitan area No
</li></ul></li></ul></div><b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Four years of research experience
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Preferred</b><ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) <b>or</b></li>
CCRP - Certified Clinical Research Professional (SOCRA)<br>
<li>
</li></ul><br>
<p><b>Company Profile:</b></p><p>
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&amp;M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.</p><p>
Houston Methodist is an Equal Opportunity Employer.</p></div>

Research Coordinator II

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Senior Data Analytics Associate will serve as a key analytical partner within the Fetal Center Research team. This role is responsible for maintaining and optimizing research databases, sustaining established Power BI dashboards, and developing new data-driven solutions that support complex fetal intervention research, including FDA regulated clinical trials. The analyst will apply advanced analytical methods, statistical modeling, and data visualization techniques to drive evidence-based decision making, ensure data integrity, and enhance operational and research outcomes across interdepartmental clinical research initiatives.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Maintain the integrity, accuracy, and performance of existing Power BI dashboards utilized for research and quality improvement.</li><li>
Manage, develop, and optimize research databases, data collection systems, and data workflows to support ongoing and upcoming fetal intervention studies and FDA regulated clinical trials.</li><li>
Support identification, integration, and preparation of large clinical, imaging, and longitudinal research datasets generated across interdepartmental partners.</li><li>
Interpret complex clinical and research data using advanced statistical and analytics techniques; develop predictive models to support fetal intervention planning, patient risk stratification, and trial outcomes forecasting.</li><li>
Identify, analyze, and interpret trends or patterns within high volume, multifaceted datasets relevant to maternal&ndash;fetal research.</li><li>
Develop new dashboards, data visualization aids, and analytic tools tailored to the unique needs of fetal intervention studies, regulatory reporting, and research publications.</li><li>
Work collaboratively with physicians, research coordinators, statisticians, data managers, and interdepartmental partners within Texas Children&rsquo;s Hospital Fetal Center to understand research and operational requirements and translate them into intuitive analytic solutions.</li><li>
Provide consultative analytics support to clinical trial teams, offering actionable insights to guide process improvements, protocol planning, and research strategy.</li><li>
Prepare high quality, well documented analytic outputs that support manuscripts, presentations, grants, regulatory submissions, and internal research reviews.</li><li>
Recommend enhancements to data collection procedures, analytic processes, and reporting systems to increase statistical efficiency, regulatory compliance, and team effectiveness.</li><li>
Continuously refine and improve analytics pipelines supporting fetal center workflows, multi site collaborations, and clinical trial operations.</li><li>
Perform other duties as assigned to support the mission of the Fetal Center Research team.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree. Four years of relevant experience may substitute for degree requirement.</li><li>
Four years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications and Skills</b></h2></div><div><ul><li>
Experience with REDCap, MS Excel and Power BI.</li><li>
Previous experience in research data management.</li><li>
Requires experience with computer spreadsheets and database management (experience with developing and maintaining databases in REDCap preferred).</li><li>
Self-directed, independent and organized.</li><li>
Requires critical thinking and interpersonal skills necessary to coordinate large data sets within a multi-disciplinary team.</li></ul></div></div></div><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p><p></p><p><br>
SN; Nature</p></div>

Senior Data Analytics Associate - Clinical Research Data

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Regulatory Affairs Associate works to support the Protocol Office and investigators associated with Baylor College of Medicine Department of Pediatrics at The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of clinical trials. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This position requires expertise and understanding of clinical research and applicable regulations.</p><p></p><p><br>
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Coordinates regulatory correspondence across internal stakeholders and external institutions.</li><li>
Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.</li><li>
Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.</li><li>
Maintains working knowledge of regulatory requirements through independent continuing education using guidelines, articles, and courses.</li><li>
Develops and maintains positive relationships with institutional review committees and sponsor through oral and written communications.</li><li>
Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.</li><li>
Facilitates investigators in reporting and responding to institutional review committees' and other regulatory agencies' inquiries or comments.</li><li>
Provides input to the investigators in consent form creation and protocol editing.</li><li>
Works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.</li><li>
Prepares for FDA meetings, inspections, and audits from regulatory authorities. Is available on site during audit visit to reply to auditor inquiries.</li><li>
Facilitates communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.</li><li>
Assures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects.</li><li>
Maintains regulatory database as applicable. Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready.</li><li>
Keeps the study team and supervisor informed of protocol related issues.</li><li>
Participates in feasibility, implementation, and site initiation meetings, teleconferences, monitor visits, research audits and other onsite meetings as required.</li><li>
Practices a high level of integrity and honesty in maintaining confidentiality.</li><li>
Works proactively and collaboratively with other team members to streamline work and achieve mutual goals.</li><li>
Attends all required meetings and conferences, contributes pertinent protocol information and uses information presented to develop an understanding of the hematology/oncology landscape, in order to more accurately assist in the preparation of submissions.</li><li>
Plans and pursues activities to promote self development related to hematology/oncology and regulatory issues. Looks for opportunities to improve performance; manages time, work, and relationships effectively and efficiently.</li><li>
Performs other job related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree.</li><li>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Department Specific Criteria</b></h2></div><div><ul><li>
Two or more years of experience in regulatory affairs for clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.</li><li>
Demonstrated knowledge of regulatory processes and applicable regulations.</li><li>
Ability to manage regulatory aspects of multiple research projects.</li><li>
Ability to establish and maintain cooperative and mutually supportive working relationships with faculty, administrators, staff, other campus units, sponsors, their representatives, and other business partners.</li><li>
Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.</li><li>
Ability to serve as a resource to clinical investigators and staff.</li><li>
Ability to manage shifting priorities in short time frames.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Certification in Clinical Research, SOCRA or other preferred.</li><li>
Should have excellent oral and written communication skills.</li><li>
Knowledge of medical/scientific terminology.</li><li>
Excellent organization skills; ability to multi-task.</li><li>
Strong computer skills including Microsoft Office Suite.</li><li>
High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organization.</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div>

Regulatory Affairs Associate - Clinical Research

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