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clinical care coordinator - pedi cv surgery

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care transitions coordinator home health

clinic director i licensed physical therapist assistant (pta) - care coordination Jobs in Houston

clinical care coordinator - pedi cv surgery Jobs in Houston

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

clinical care coordinator pedi cv surgery

Baylor College of Medicine

Job Description
<br><br>
<b>Job Title:</b> Physician Assistant or Nurse Practitioner - Thoracic Surgery (Inpatient)
<br><b>Division:</b> Surgery
<br><br>
<b>Work Arrangement:</b><br>
<b>Location:</b> Houston, TX
<br><br>
<b>Salary Range:</b><br>
<b>FLSA Status:</b> Exempt
<br><br>
<b>Work Schedule:</b><br>
Summary
<br><br>
The David J. Sugarbaker Division of Thoracic Surgery in the Michael E. DeBakey Department of Surgery is seeking a qualified Advanced Practice Provider to provide high quality surgical care under the direction of a group of physicians at Baylor St. Luke’s Medical Center. Candidate will be expected to provide clinical excellence and scholarly enthusiasm. The provider will have direct patient care responsibilities. The selected candidate will be appointed as a faculty Instructor and be eligible for full faculty benefits.
<br><br>
Job Duties
<br><br>
Primary responsibilities include inpatient care of thoracic surgery patients in coordination with attending physician and resident physician teams. This will include thorough pre-round chart review, engagement in collaborative rounds with attending physicians as well as independent rounding, documentation of clinical decision-making and treatment plans, coordination and execution of the day’s care plan, including wound management and other procedural interventions as needed, and frequent follow up on pt progress and testing to ensure patients are progressing through their plan of care.
<br><br>
Obtain detailed history and perform physical examinations. See consults independently and/or with residents/fellows in various settings – floor, ICU, ED, etc.
<br>Formulate assessments and plans and evaluate the patient response to care
<br>Order and interpret appropriate diagnostic procedures, including, but not limited to x-rays, electrocardiograms, laboratory tests, and MR and CT imaging
<br>Ensure timely and accurate documentation in the EPIC electronic medical record system
<br>Prescribe appropriate pharmacological and non-pharmacological treatments (while inpatient and upon discharge)
<br>Educate patients on prescribed therapeutic regimens, home care and health maintenance
<br>Remove chest tubes and JP drains as indicated, provide wound care to chest tube sites and surgical wounds
<br>Perform bedside simple wound debridement, suture closure, and bedside intrapleural therapeutic procedures
<br>Provide wound care and education on cervical esophagostomies, negative pressure wound therapies (wound vac), feeding tubes, indwelling pleural catheters, and tracheostomies to patients and staff
<br>Provide guidance and work direction to support staff, including, but not limited to nurses, social workers, and clinic coordinators
<br>Optimize discharge planning for all patients including participation in daily multidisciplinary rounds for floor and ICU patients, as well as timely and clear discharge communication to outpatient team
<br>Communicate with physicians, patients, and the family members of patients concerning patient care
<br>Provide orientation, direction and support to PA/NP students, medical students, and/or residents assigned to the service
<br>Promote a positive work environment with a team-based approach through supportive and respectful interactions with peers, staff, learners, and faculty
<br>Other duties as assigned
<br>Minimum Qualifications
<br><b>Education Required:</b> Master’s degree in in Nursing.
<br><b>Experience Required:</b> None required.
<br><b>Certification/Licenses/Registration:</b> Current license as a Registered Nurse (RN) by the State of Texas Board of Nursing. Current Texas Licensure as an Advanced Practice Nurse (APRN-NP), and specialty certification as required by department. Basic Life Support (BLS) Certification
<br>Required Qualifications
<br>Master's degree from an accredited Physician Assistant/Nurse Practitioner Program
<br>Board certification by appropriate certifying organization
<br>Licensed as a Physician Assistant/Nurse Practitioner in the State of Texas
<br>DEA certification
<br>Preferred Qualifications
<br>Surgical experience preferred
<br><br>
<b>Work Authorization Requirement:</b><br>
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
<br><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
<br><br>
<b>Requisition ID:</b> 24555

Physician Assistant or Nurse Practitioner - Thoracic Surgery (Inpatient)

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Department of Neonatology at Texas Children&rsquo;s Hospital is seeking a highly motivated individual to join our team as a Research Coordinator I. This entry-level position provides an excellent opportunity for someone interested in clinical research, with a focus on neonatal care. The Research Coordinator I will assist in coordinating research studies, collecting and managing data, and supporting study investigators, while working under supervision to ensure compliance with regulatory requirements. This role offers valuable experience in neonatal research and is ideal for candidates looking to develop skills in a clinical research environment.</p><p></p><p><br>
The Department of Neonatology at Texas Children&rsquo;s Hospital is dedicated to improving outcomes for critically ill newborns through cutting-edge research and clinical care. Our studies focus on areas such as neonatal nutrition, respiratory support innovations, neurodevelopmental outcomes, and interventions for preterm and low-birth-weight infants.</p><p></p><p><br>
This position is located within the Neonatology Department at Texas Children&rsquo;s Hospital in the Texas Medical Center. The role involves working closely with multidisciplinary teams in a fast-paced neonatal intensive care unit (NICU) setting to coordinate and support impactful clinical research studies.</p><p></p><p><br>
The successful candidate will demonstrate strong attention to detail, exceptional organizational skills, and the ability to manage multiple tasks in a fast-paced environment. They should excel in written and verbal communication, work effectively as part of a multidisciplinary team, and exhibit a passion for clinical research in neonatal care.</p><p></p><div><br>
Internal candidates with laboratory experience and an interest in clinical research are strongly encouraged to apply.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><p>
Performs research coordination and administrative duties to support the successful execution of clinical research studies in neonatology, contributing to the department&rsquo;s mission of advancing neonatal care through innovative research.</p><p>
50% - Study Coordination and Regulatory Compliance</p><ul><li>
Assist in coordinating neonatal clinical research studies focusing on conditions such as preterm birth, neonatal respiratory support, and neonatal nutrition, under the supervision of senior research coordinators or principal investigators.</li><li>
Help prepare and submit study-related documents, including protocols, consent forms, and regulatory submissions (e.g., IRB applications), ensuring compliance with institutional and federal guidelines.</li><li>
Monitor and report on study progress, including patient recruitment, data collection, and adherence to study protocols, with guidance and oversight from senior staff.</li><li>
Maintain organized study files, ensuring accurate documentation of study activities, regulatory submissions, and communications for potential audits.</li><li>
Collaborate with multidisciplinary teams, including NICU nurses, neonatologists, and research faculty, to support study execution and troubleshoot minor issues as they arise.</li></ul><p></p><p><br>
30% - Data Collection and Management</p><ul><li>
Collect, manage, and track data related to neonatal participants, such as clinical outcomes, lab results, and vital signs, under supervision.</li><li>
Input study data into specialized neonatal research databases (e.g., REDCap), ensuring accuracy, completeness, and adherence to HIPAA regulations.</li><li>
Assist with data quality checks to identify discrepancies or inconsistencies, escalating any concerns to senior staff for review and resolution.</li><li>
Perform basic statistical analysis or data entry as directed by senior team members, ensuring that all data collected is validated and meets study requirements.</li></ul><p></p><p><br>
10% - Participant and Family Interaction</p><ul><li>
Assist in recruiting neonatal patients and obtaining informed consent from parents or guardians for participation in research studies, following ethical guidelines and with oversight.</li><li>
Coordinate scheduling for study visits in collaboration with families and NICU staff to ensure minimal disruption to patient care and study protocol adherence.</li><li>
Provide compassionate support to families, answering basic questions about the research process and addressing concerns, with guidance from senior team members when necessary.</li><li>
Work with NICU staff to facilitate smooth study visits and ensure that clinical care is not interrupted during research procedures.</li></ul><p></p><p><br>
10% - Administrative and Team Support</p><ul><li>
Support senior research coordinators and principal investigators with administrative tasks such as scheduling meetings, maintaining study calendars, and preparing documentation for audits or monitoring visits.</li><li>
Coordinate with other hospital departments (e.g., NICU nursing, pharmacy, laboratory services) to ensure smooth execution of study protocols and foster interdepartmental communication for study efficiency.</li><li>
Performs other job duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
High School diploma or GED.</li><li>
Three years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Bachelor&rsquo;s degree in a relevant field (e.g., Biology, Health Sciences, Public Health, or related disciplines).</li><li>
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).</li><li>
Experience with research data management systems such as REDCap or Epic.</li><li>
Familiarity with Good Clinical Practice (GCP) guidelines, IRB submissions, and HIPAA compliance.</li><li>
Familiarity with clinical research processes.</li><li>
Strong preference for candidates with prior laboratory experience or interest in lab-responsibilities</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>

Research Coordinator I - Pediatrics - Newborn

Ocular Clinical Trials

<p>Welcome to the Ocular Clinical Trials at Vision Optique. We are proud to lead the way in ocular clinical research and are committed to helping advance the future of eye care. Since 2020, we&rsquo;ve conducted 20+ pre-clinical, Phase I-IV clinical trials, and we continue to actively enroll participants in new studies.</p><p>We are seeking an experienced Clinical Research Coordinator (CRC) who will work on site to help ensure that quality research is conducted in accordance with the Sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data.</p><p>The CRC will play a key role in managing day-to-day operations of optometry-related clinical studies, including participant recruitment, informed consent, study visits, data collection, and regulatory compliance. The ideal candidate has prior experience in clinical research, excellent organizational skills, and an interest in advancing vision science and ocular health.</p><p>Responsibilities</p><ul><li>Complete all sponsor-required and study-specific training (protocols, amendments, manuals, EDC/IVRS, and electronic systems) in a timely manner.</li><li>Conduct study visits and protocol-required procedures with the PI/Sub-I, ensuring accurate and timely documentation per ALCOA-C standards.</li><li>Perform study-related assessments (e.g., visual acuity testing, ocular imaging, intraocular pressure measurement) under PI supervision.</li><li>Recruit, screen, and enroll eligible participants; obtain informed consent and ensure participant understanding of study procedures, risks, and benefits.</li><li>Support subject retention through clear communication and engagement with research participants.</li><li>Collect, enter, and verify data in eCRFs; resolve queries promptly per sponsor and site guidelines.</li><li>Manage study visit scheduling, follow-ups, and participant communications.</li><li>Maintain regulatory binders and prepare/submit required IRB and sponsor documentation on schedule.</li><li>Ensure proper handling of investigational product (IP), including storage, temperature monitoring, calibration, inventory, and compliance with pharmacy manuals.</li><li>Liaise with investigators, research staff, administrative personnel, participants, sponsors, CROs, and monitors to ensure smooth study operations.</li><li>Adhere to GCP, FDA, IRB, and institutional regulations at all times.</li><li>Contribute to study reports and presentations as needed.</li><li>Perform additional tasks as assigned by management.</li></ul><p>Requirements</p><ul><li>Bachelor&rsquo;s degree in life sciences, healthcare, optometry, or related field</li><li>1&ndash;2 years of experience in clinical research or healthcare setting</li><li>Knowledge of clinical research regulations (GCP, ICH guidelines, FDA) with GCP and Biomed certifications</li><li>Strong organizational, interpersonal, and communication skills</li><li>Ability to manage multiple projects and maintain attention to detail</li></ul><p>Preferred:</p><ul><li>Familiarity with ophthalmic diagnostic tools and procedures</li><li>Phlebotomy skills and/or experience with biological sample collection</li></ul><p>Pay: $22.00 - $25.00 per hour</p><p>Benefits:</p><ul><li>Dental insurance</li><li>Health insurance</li><li>Paid time off</li><li>Vision insurance</li></ul><p>Work Location: In person</p>

Clinical Research Coordinator

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><div>
The Texas Children&rsquo;s Cancer and Hematology Centers (TXCH) Research Coordinator II is responsible for supporting the implementation and coordination of day-to-day activities for clinical research protocols across various oncology teams. This role helps ensure accurate data collection, documentation, organization, and the safety of study participants. The Research Coordinator II also serves as a liaison among study participants, investigators, sponsors, and other healthcare professionals involved in research and patient care.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><div><p><b>
Supports daily operations for a research study or clinical trial</b></p><ul><li>
Consults with the Principal Investigator (PI) and providers regarding research data.</li><li>
Assists the PI and/or providers with study patient enrollment.</li><li>
Interviews, screens, and recruits patients for therapeutic and non-therapeutic studies; performs the informed consent process for biology, procurement, and registry studies; and explains processes and procedures to educate participants about the research study.</li><li>
Collects patient information through direct interviews, questionnaires, and chart abstraction; processes documents and enters information into databases or case report forms (CRFs).</li><li>
Collaborates with study teams and physicians to determine patient eligibility for research protocols.</li><li>
May schedule research participants for tests and procedures (e.g., laboratory tests, X-rays, and other protocol-specific studies) and retrieves and submits results to appropriate parties.</li><li>
Works with multiple departments to coordinate diagnostic procedures.</li><li>
Assists with site selection and site initiation visits by coordinating schedules with external monitors and internal departments.</li><li>
Collects, evaluates, enters, and tracks research data.</li><li>
Collects research patient information (e.g., medical history, lab results) from the electronic medical record (EMR).</li><li>
Maintains accurate source documentation and CRFs in compliance with study protocols.</li><li>
Reviews research orders in Epic/Beacon with providers to ensure accuracy and completeness.</li></ul><p></p><p><b>
Submits data, study documents, and/or reports to regulatory agencies</b></p><ul><li>
Submits accurate research data via CRFs to external entities in a timely manner.</li><li>
Provides prompt and appropriate responses to sponsor data requests or queries.</li></ul><p></p><p><b>
Assists with completion of protocol-specific documents</b></p><ul><li>
Monitors protocol compliance and communicates deviations, errors, or incomplete documentation appropriately.</li></ul><p></p><p><b>
Establishes study files and prepares study-related documentation</b></p><ul><li>
Creates and maintains research charts.</li><li>
Updates internal and external databases in accordance with departmental, sponsor, and study requirements.</li></ul><p></p><p><b>
Collects samples from participants</b></p><ul><li>
Collects, processes, ships, and maintains documentation for blood and/or biological specimens according to study protocols and standard operating procedures (SOPs).</li></ul><p></p><p><b>
Performs other job-related duties as assigned</b></p><ul><li>
May order supplies and equipment.</li><li>
May perform neurocognitive testing.</li><li>
Seeks guidance from the Clinical Research Manager for additional assignments.</li></ul><p></p><h3 class="jobSectionHeader"><b>
% of Time Spent on Duties</b></h3><ul><li>
30% &ndash; Informed consent and patient recruitment</li><li>
20% &ndash; Biological sample management</li><li>
20% &ndash; Data abstraction</li><li>
15% &ndash; Data management and query resolution</li><li>
10% &ndash; Research document completion (e.g., CRFs, study logs, internal reports)</li><li>
5% &ndash; Research chart organization</li></ul></div><ul><li>
Performs other job duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.</li><li>
One year of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Requires effective verbal and written communication skills.</li><li>
Requires proficiency with computers, internet and Microsoft Office applications.</li><li>
May require experience with computer spreadsheets and database management.</li><li>
May require the ability to understand and implement patient studies and protocols.</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>

Research Coordinator II - Pediatrics - Hematology & Oncology Clinical Research

Houston Methodist

<div>At Houston Methodist, the Research Coordinator 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. This position ensures accurate data collection, documentation, organization and safety of research participants.
<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>
Two years&rsquo; research experience
</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>Sufficient in clinical and research data entry
</li><li>Capable of handling challenging/difficult situations
</li>Demonstrates sound judgment and executes 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 higher level staff, conducts screening and interviews to evaluate patient eligibility in study.
</li><li>Promotes a positive work environment and contributes to a dynamic, team focused work unit that actively helps one other to achieve optimal department results. Collaborates with all members of the patient care team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
</li><li>Provides contributions towards improvement of department scores for employee engagement.
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Responds promptly and accurately to customer complaints, inquiries, and requests for information and coordinate appropriate follow-up calls and/or appointments.
</li><li>Schedules research subject appointments for tests and procedures, such as laboratory tests, x-rays, and other studies specific for the research protocol.
</li><li>Compiles patient information, process, document and enter accurate information in Source Documents, Case Report Forms, Electronic Data Capture portals and Clinical Trial Management System following established procedures.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Maintains records for clinical study and regulatory documents.
</li><li>Under the direction of Research Nurse/Clinical Trial Manager/Physician, captures and reports Adverse Events (A/E) or Serious Adverse Events (SAE) to necessary regulatory authorities.
</li><li>Assists management with research records and regulatory maintenance.
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Uses resources efficiently; does not waste supplies. Evaluates and reports on inventory levels. Self-motivated to independently manage time effectively and prioritize daily tasks.
</li><li>Maintains inventory of supplies necessary for the study.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Maintains working knowledge of the research process and in the conduct of IRB approved research protocols. Follows International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines.
</li>Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development. Completes and updates My Development plan on an on-going basis.<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>
Two years&rsquo; research experience<br>
<ul><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>

Clinical Trial Research Coordinator I

<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

Texas Children's Hospital

<div><p>We are searching for an Director I Inpatient Nursing - CICU - someone who works well in a fast-paced setting. In this position, you will manage and oversee daily clinical, administrative, and human resource activities for the designated clinical area(s), including providing 24-hour availability. This position also coordinates, and ensures the delivery of high-quality, developmentally appropriate patient and family-centered care at the unit level.<br>
</p><p></p><p>Think you&rsquo;ve got what it takes?<br>
</p><p></p><p>Job Duties &amp; Responsibilities
</p><ul><li>Partners with staff, medical, and unit leadership to ensure clinical excellence within a family-centered care environment, utilizing multiple sources of information and reports as evidenced by trend identification and action plan development. Participates as a full partner with Medical Director and in partnership with healthcare provider team to ensure cohesive department communication
</li><li>Demonstrates astute fiscal accountability, for the area of clinical responsibility, as evidenced by the appropriate management and justification of resources, which includes personnel, equipment, supplies, and capital
</li><li>Creates and facilitates collaboration and cooperation among diverse groups, people, and professional disciplines to achieve desired results
</li><li>Facilitates staff participation and participates in the Quality Outcomes Program and/or unit-based quality initiatives for the purpose of developing and monitoring exemplary clinical outcomes
</li>Commits to the ongoing development of self, unit leadership team, and staff to achieve professional goals<br>
<li>
</li></ul><p></p><p>As part of our commitment to maintaining a safe and healthy workplace, all successful candidates will be required to undergo respiratory fit testing in compliance with occupational health and safety standards.<br>
</p><p></p><p>Skills &amp; Requirements
</p><ul><li>Bachelor's Degree Nursing
</li><li>Master's Degree Nursing, Business or healthcare field
</li><li>RN - Lic-Registered Nurses &amp; BLS - Cert-Basic Life Support
</li><li>3 years&rsquo; experience in management/leadership</li></ul></div><p></p>

Director I Nursing, Inpatient - CICU

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