clinical research coordinator

research administrator ii Jobs in Houston

research administrator ii

clinical data coordinator Jobs in Houston

clinical data coordinator

clinical research assistant Jobs in Houston

clinical research assistant

clinical research associate - fsp oncology, resp, gen med, vaccine - central us Jobs in Houston

clinical research senior quality assurance and control associate

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Senior Quality Assurance and Control Associate (Senior QA/QC Associate) will monitor clinical research study activities for the Texas Children's Cancer and Hematology Centers (TXCH) and the BCM Center for Cell and Gene Therapy (CAGT) to ensure compliance with all relevant local, federal, and state regulatory and institutional policies while identifying protocol problems, reviewing study-related documents, and ensuring that appropriate corrections are made and documented for missing or incomplete data. Under the guidance and supervision of the QA/QC Manager, the Senior QA/QC Associate will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff. The Senior QA/QC Associate will also review and update existing clinical research Standard Operating Procedures (SOPs) as well as develop new SOPs as needed.</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>
Monitors protocol compliance and documentation, performs clinical study conduct reviews, and verifies clinical research staff competencies. This includes review of investigator-initiated, group sponsored, industry sponsored, treatment and non-treatment studies administered by TXCH and CAGT.</li><li>
Provides SOP training for TXCH and CAGT clinical research staff.</li><li>
Develops, distributes, and maintains clinical research standard operating procedures based on regulations and implements improvements as necessary.</li><li>
Ensures procedures meet or exceed all relevant institutional, state, and federal requirements for the conduct of clinical research; and ensures clinical research activities are conducted, generated, documented, and reported in compliance with the protocol, Good Clinical Practice (GCP) guidelines, and all other applicable regulatory agencies.</li><li>
Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA, industry sponsors, or cooperative groups.</li><li>
Prepares QC review reports for principal investigators (PIs) and clinical research teams to effectively communicate findings, and works with TXCH and CAGT leadership to provide suitable recommendations for corrective actions.</li><li>
Presents QC review reports to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.</li><li>
Performs other job-related duties as assigned.<br>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree.</li><li>
Four years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
B.S. or B.A. in science or health related field</li><li>
CCRA, CCRP, or CCRC</li><li>
Knowledge of clinical research operations, medical terminology, and anatomy</li><li>
Prior oncology clinical research QA/QC experience</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>

Clinical Research Senior Quality Assurance and Control Associate

Harris Health

<p></p><div><div><div><p>Harris Health System is the public healthcare safety-net provider established in 1966 to serve the residents of Harris County, Texas. As an essential healthcare system, Harris Health champions better health for the entire community, with a focus on low-income uninsured and underinsured patients, through acute and primary care, wellness, disease management and population health services. Ben Taub Hospital (Level 1 Trauma Center) and Lyndon B. Johnson Hospital (Level 3 Trauma Center) anchor Harris Health&rsquo;s robust network of 39 clinics, health centers, specialty locations and virtual (telemedicine) technology. Harris Health is among an elite list of health systems in the U.S. achieving Magnet&reg; nursing excellence designation for its hospitals, the prestigious National Committee for Quality Assurance designation for its patient-centered clinics and health centers and its strong partnership with nationally recognized physician faculty, residents and researchers from Baylor College of Medicine; McGovern Medical School at The University of Texas Health Science Center at Houston (UTHealth); The University of Texas MD Anderson Cancer Center; and the Tilman J. Fertitta Family College of Medicine at the University of Houston.</p></div><div><p>
JOB SUMMARY: Performs moderate and selected high complexity tests on clinical laboratory specimens in various laboratory sections. Validates and report results of tests performed. Performs and documents Quality Control. Performs instrument and equipment maintenance according to policy and procedures. Maintains adequate stock of reagents and supplies. Participates in continuing education.
<br>
<br>
MINIMUM QUALIFICATIONS:
<br>
<br>
Education/Specialized Training/Licensure: Associate Degree/ Medical Technology/Clinical Laboratory Science or related science Biology, Chemistry, or Physics/Certification by approved certifying agency, i.e., ASCP, NCA, AMT<br>
<br>
Work Experience: Recent Graduate must be certified by ASCP or equivalent Board within one year of graduation.
<br>
Equipment Operated: PC, printers, scanners.<br>
<br>
SPECIAL REQUIREMENTS:
<br>
Communication Skills:<br>
Above Average Verbal (Heavy Public Contact)<br>
Writing /Composing (Correspondence/Reports)<br>
<br>
Other Skills:<br>
Analytical, CRT, Medical Terms, Research, Statistical, P.C., MS Word, MS Excel, MS Access<br>
<br>
Advanced Education:<br>
Bachelor's Degree Major: Associate Degree/ Medical Technology/Clinical Laboratory Science or related science Biology, Chemistry, or Physics
<br>
<br>
Work Schedule: Flexible<br>
<br>
Other Requirements: Travel between Harris Health System facilities</p></div></div></div>

Sup Medical Lab Technician- LBJ

MD Anderson Cancer Center

<div><b>Associate Director of Inpatient Pharmacy
</b><br>
<br>
The <b>Associate Director of Inpatient Pharmacy</b> at MD Anderson Cancer Center is a senior leadership role responsible for overseeing all aspects of <b>Inpatient pharmacy operations</b>, including clinical services, medication-use systems, and workflow efficiency. This position manages and develops pharmacy staff, ensures adherence to regulatory and accreditation standards, and drives quality and safety initiatives within the inpatient care environment.<br>
<br>
The<b> Ideal candidate </b>for the Associate Director of Inpatient Pharmacy at MD Anderson is an experienced hospital pharmacy leader with strong operational, clinical, and regulatory expertise. This individual excels at managing complex inpatient pharmacy workflows, leading diverse teams, and driving quality and patient-safety initiatives. They collaborate effectively with physicians, nursing, and administrative partners, and bring a proactive, solutions-focused approach to improving medication-use processes. A commitment to innovation, service excellence, and MD Anderson's mission of outstanding patient care is essential.<br>
<br>
<b>Working Hours: This position will be </b>a Hybrid model with a potential for two days a week remote. It will be Dayshift 8a - 5p.<br>
<br>
<b>At MD Anderson, we offer careers built on care, growth, and balance. Our employees enjoy a benefits package designed to support every stage of life, starting on day one.</b><br>
<ul><li>
Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week</li><li>
Group Dental, Vision, Life, AD&amp;D and Disability coverage</li><li>
Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals</li><li>
Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs</li><li>
Tuition Assistance Program after six months of service</li><li>
Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans</li><li>
Employer paid life, AD&amp;D and an illness-related reduced salary pay program</li><li>
Extensive wellness, recognition, fitness, employee health programs and employee resource groups</li></ul><br>
<b>
Job Competencies
</b><br>
<br>
<b>Pharmacy Operations - 45%</b><br>
<ul><li>
Leads development and implementation of administrative processes to improve operational efficiency, cost savings, and quality outcomes.<ul><li>
Utilizes project management skills to meet timelines, service levels, and budget requirements.</li></ul></li><li>
Establishes cohesive and consistent pharmacy operations and standards across all inpatient pharmacy locations.<ul><li>
Provides clear direction and communication to department leaders.</li></ul></li><li>
Participates in the development and administration of policies and operating procedures.</li><li>
Assists in budget formulation and ensures operations align with financial performance standards.<ul><li>
Manages physical resources including inventory control, automation/technology, and property maintenance.</li></ul></li><li>
Provides leadership and oversight for all human resource functions, including:<ul><li>
Staffing and scheduling</li><li>
Performance management</li><li>
Professional development and succession planning</li><li>
Position requests</li><li>
Fostering a collaborative, high-performing team environment</li></ul></li></ul><br>
<b>
Quality and Regulatory - 30%</b><br>
<ul><li>
Administers and oversees the quality assurance and improvement program, with emphasis on:<ul><li>
USP , USP , and USP compliance</li><li>
Regulatory agency guidelines and requirements</li></ul></li><li>
Focuses on the implementation of best practices for quality and performance improvement, including continuous monitoring and oversight.</li><li>
Ensures departmental processes comply with institutional guidelines and regulatory requirements to maintain accreditation readiness.</li></ul><br>
<b>
Strategy and Leadership - 25%</b><br>
<ul><li>
Assists the Director with development, alignment, and execution of short- and long-range strategic plans for inpatient pharmacy services.<ul><li>
Includes goal setting, strategic initiatives, and staying current on industry trends to guide decision-making.</li></ul></li><li>
Partners with the Director and Managers on programs and initiatives that support institutional strategy and goals.</li><li>
Builds and maintains relationships with key internal and external stakeholders, including interdisciplinary teams, executive leaders, and vendors.<ul><li>
Provides leadership on institutional and divisional committees to support inpatient pharmacy operations.</li></ul></li><li>
Collaborates with the Director and Managers on new projects, service development, growth, and expansion.<ul><li>
Works closely with Clinical Pharmacy Services on initiatives that advance patient care and clinical outcomes.</li></ul></li><li>
Supports leadership in developing tools and strategies for effective workforce management and staff optimization within inpatient pharmacy services.</li></ul><br>
<b>
Education</b><br>
<ul><li>
Required: Pharm.D. from an accredited school of pharmacy. or</li><li>
Required: Bachelor's Degree Pharmacy</li><li>
Preferred: Master's Degree Pharmacy or</li></ul><br>
<b>
Experience</b><br>
<ul><li>
Pharm.D. from an accredited school of pharmacy. OR Bachelor's degree in Pharmacy. Five years of pharmacy supervisory or management experience.</li><li>
Successful completion of the LEADing Self Accelerate and/or LEADing Self Discover programs may substitute for one year of required supervisory or management experience. Completion of both programs can be substituted for a maximum of two years of supervisory or management experience.</li><li>
Preferred: 7 years Pharmacy supervisory or management experience</li></ul><br>
<b>
Licenses and Certifications</b><br>
<ul><li>
Required: RPH - Registered Pharmacist Texas State Board of Pharmacy - Pharmacist license within 90 Days</li><li>
Preferred: BLS - Basic Life Support American Heart Association (AHA) Basic Life Support (BLS) certification within 30 Days</li></ul><br>
<b>
Other Requirements: </b>Must pass pre-employment skills test as required and administered by Human Resources.
<br>
<br>
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.<br>
<br>
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.<br>
<br>
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html<br>
<br>
Additional Information
<br>
<ul><li>Requisition ID: 179490
</li><li>Employment Status: Full-Time
</li><li>Employee Status: Regular
</li><li>Work Week: Days
</li><li>Minimum Salary: US Dollar (USD) 200,000
</li><li>Midpoint Salary: US Dollar (USD) 235,000
</li><li>Maximum Salary : US Dollar (USD) 270,000
</li><li>FLSA: exempt and not eligible for overtime pay
</li><li>Fund Type: Hard
</li><li>Work Location: Hybrid Onsite/Remote
</li><li>Pivotal Position: Yes
</li><li>Referral Bonus Available?: No
</li><li>Relocation Assistance Available?: No
</li></ul><br>
#LI-Hybrid</div>

Associate Director - Inpatient Pharmacy

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Department of Psychiatry and Behavioral Sciences is seeking a dynamic and detail-oriented individual to join our team as a Research Administration Associate. In this role, you will provide critical support in the management of clinical research projects within Baylor College of Medicine&rsquo;s Department of Psychiatry and Behavioral Sciences. This role will primarily focus on pre award grant management. The Research Administration Associate will work closely with faculty, staff, and external stakeholders to ensure compliance with regulations and facilitate the smooth execution of our research mission.</p><p></p><p><br>
Employees with CRA certification are eligible for certification pay.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Work collaboratively with principal investigators and sub-award institutions to prepare grant applications responsive to the funding opportunities, including the development of budgets and justifications, the collection of required documents, the routing of proposal for internal review, and the completion of the final application.</li><li>
Maintain timelines and communicate regularly with investigators to ensure the timely submission of grant proposals.</li><li>
In collaboration with the Senior Research Administrator, proactively manage award setups and budget allocations.</li><li>
Facilitate both incoming award and outgoing sub-award agreements and contracts.</li><li>
Assist with keeping current compliance requirements such as IACUC approvals, IRB approvals, and Conflict of Interest attestations.</li><li>
Support research faculty in the procurement of needed supplies, the reimbursement of expenses, and the resolution of delayed payments.</li><li>
Monitor and work with investigators to keep biosketches, CVs, CITI trainings, Other Support, VA-Memorandums of Understanding current, IRB approvals, IACUC approvals, and Conflict of Interest attestations current.</li><li>
Perform other job-related duties as assigned.<br>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree. Certified Research Administrator certification through the Research Administrators Certification Council (RACC) may substitute for the degree requirement.</li><li>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Excellent written, verbal, and customer-centric communication skills, with a keen attention to detail.</li><li>
Strong organizational skills with the ability to prioritize tasks and manage deadline driven projects simultaneously.</li><li>
Proficiency in Microsoft Office Suite (e.g. Word, Excel, Teams).</li><li>
Familiarity with research administration systems (e.g., BRAIN, ASSIST, SAP, Concur, Grants.gov, Proposal Central, eRA Commons).</li><li>
Knowledge of federal regulations and policies governing sponsored research (e.g., NIH, NSF, DHHS, OMB 2CFR200 Uniform Guidance).</li><li>
Experience with federal, state, and foundation sponsors (NIH, NSF, DOD).</li><li>
Familiarity with research proposal sponsor websites (ASSIST, Research.gov, grants.gov, and Proposal Central).</li><li>
Familiarity of 2 CFR 200 guidance.</li><li>
Ability to work collaboratively in a team environment and independently with minimal supervision.</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 Administration Associate - Pre Award

<div>The MD Anderson <b>Cord Blood Bank Program</b>creates a lifesaving product from something that was once considered medical waste. Umbilical cord blood is the blood that remains in the placenta and umbilical cord after a baby is born. This blood contains stem cells, which can be used to treat patients with many life-threatening diseases, including cancer. As a public cord blood bank, collectors collect voluntary donations from mothers at several Houston-area hospitals. Collecting cord blood poses no danger to either the mother or the baby. Our inventory is available to transplant facilities worldwide for patients who require stem cell transplantation.<br>
<br>
<b>SUMMARY</b><br>
The primary role of the Quality Assurance Specialist position is to manage cleanroom facility, support document control system, training, competency, audit and incident reporting in compliance with the Cord Blood Bank quality assurance program and applicable regulatory and accreditation agencies including but not limited to FDA, FACT, and CAP. Review all quality documents for compliance with CBB quality assurance program, standard operating procedures and policies, as well as regulatory/accreditation agencies. Coordinate development and implementation of internal and external audits in collaboration with the Cord Blood Bank Management Team. Review all batch records, quality control testing records, and complete final reviews of CBU records for unit listing on national and international stem cell registries. Review all CBU records, shipment documents and Certificates of Conformance prior to release of a unit for distribution and clinical use. Participate in continuous quality improvement of banking activities.
<br>
<br>
The ideal candidate for this Per Diem role will have previous experience working in the Cord Blood Bank at MD Anderson.
<br>
<br>
<b>At MD Anderson, we offer careers built on care, growth, and balance. Our employees enjoy a benefits package designed to support every stage of life, starting on day one.</b><br>
<ul><li>
Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week</li><li>
Group Dental, Vision, Life, AD&amp;D and Disability coverage</li><li>
Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals</li><li>
Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs</li><li>
Tuition Assistance Program after six months of service</li><li>
Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans</li><li>
Employer paid life, AD&amp;D and an illness-related reduced salary pay program</li><li>
Extensive wellness, recognition, fitness, employee health programs and employee resource groups</li></ul><br>
<b>
KEY FUNCTIONS</b><br>
<br>
Environmental Monitoring and Facility Quality Compliance
<br>
<ul><li>Provide oversight of the CBB Environmental Monitoring (EM) program including establishment of sampling plans, routine trending, and excursion response procedures in accordance with applicable regulatory guidelines and the CBB Quality Management plan.
</li><li>Ensure environmental monitoring is performed, under both static and dynamic conditions, including during production of the biological product, trended and acted upon, to include, but not limited to, microbiological and particle levels.
</li><li>Collaborate with MD Anderson's housekeeping department to ensure the cleaning of the facility to appropriate standards by staff who are trained and competent to clean and sanitize the classified areas.</li><li>
Provide oversight for the qualification and quality control release testing for raw materials, in-process materials, components, and finished products in accordance with cGMP regulations, regulatory filings and approved procedures, including growth promotion testing for all media used in microbiology and EM program.</li><li>
Manage automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system. d. Maintain an aseptic processing monitoring program of both facility and personnel.
</li><li>Drive corrective/preventative actions, ensuring work is complete and the labs remain in a state of control.
</li><li>Review and monitor performance indicator data relating to the cleanroom facility to identify, develop and implement quality and process improvements.
</li><li>Manage environmental excursion investigations.
</li><li>Ensure corrective actions identified for the investigation are implemented in a timely manner and monitored as part of the monthly trending meetings.
</li><li>Develop, implement and manage training, qualification and monitoring of staff using the cleanroom facility, including, but not limited to, access, gowning, hygiene, aseptic technique, cleanroom behavior and patient safety hazards posed by a non-sterile biological drug product.
</li><li>Ensure Employee and Environmental Health and Safety implications of CB banking activities are properly managed as required by institutional and external regulatory guidelines.
</li><li>Work closely with Institutional Facilities to ensure CBB cleanroom facility meets Biological Licensure requirements according to FDA guidelines.
</li><li>Perform quarterly safety inspections.
</li><li>Communicate deficiencies and ensure follow up of action items.
</li></ul><br>
Quality Program Management
<br>
<ul><li>Maintain current knowledge of technical procedures, policies and applicability of respective regulations and standards including but not limited to FDA's current Good Tissue Practices and Good Manufacturing Practices, standards set by accreditation agencies including but not limited to FACT-NetCord and CAP. Ability to educate staff on the technical principles as well as applicable regulatory requirements defined in policies and procedure.
</li><li>Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training.
</li><li>Monitor the training and competency evaluation of CBB staff.
</li><li>Review and audit training and competency records for all activities under the CBB quality management program.
</li><li>Provide oversight of Proficiency Testing program, submit final reports and investigate failures, develop and implement corrective actions.
</li><li>Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies.
</li><li>Assist, guide and mentor employees assigned to performing SOP review and revisions.
</li><li>Support Controlled Document System and Standard Operating Procedure (SOPs) Development and Review.
</li><li>Contribute to the maintenance and management of document control system; including review, approval, implementation, revision, distribution and archiving of documents.
</li><li>Perform annual review of assigned controlled documents and associated controlled documents changes as necessary</li><li>
Responsible for writing, reviewing and revising technical SOPs and policies as assigned, ensuring they are updated to include regulatory and agency changes.</li><li>
Design, direct execution and summarize designated validations, developing the corresponding SOPs and worksheets.
</li><li>Ensure validation will meet all required regulatory endpoints. k. Responsible for the qualification of assigned SOPs.
</li><li>Assist, guide and mentor employees assigned to performing such studies.
</li></ul><br>
Quality System Support
<br>
<ul><li>Responsible for providing quality assurance reviews and ensuring compliance and completeness of 3rd party lab results, manufacturing batch records, and quality control lab testing records including, but not limited to, environmental monitoring data, sterility data, batch records, and CBU file completeness, suitability for listing, donor eligibility and licensure status. This includes following-up to ensure any corrective actions are compliantly addressed and files are properly closed.</li><li>
Complete final review of CBU for listing on stem cell donor registries including confirming Donor Eligibility and licensure status as well as conformance of the CBU to all BLA specifications.</li><li>
Complete review of all products, including internal quality assessments, to confirm all release criteria are met, any incidents have been investigated and closed, and shipment documentation including Certificates of Conformance, are complete prior to release for distribution and clinical use.</li><li>
Review testing of product; including follow-up of outstanding results, resolution of reactive/abnormal results, reporting to physicians and/or appropriate agencies as applicable.</li><li>
Responsible for inspection and release of lot labels as well as investigating events related to labeling errors or missing labels.</li><li>
Assist with the management of automated monitoring system to include daily and monthly review of monitors, investigation of alarms, implementation of corrective actions when applicable, management of annual probe calibrations and training of employees on use of system.</li><li>
Ensure proper documentation of deviations and incidents, accidents, out of specification results, product recall, and product complaints including staff training and monitoring of competencies.</li><li>
Perform quality management review of deviations and incidents, identify issues and problems, and assist in investigations, evaluating possible causes.</li><li>
Identify corrective and preventative actions (CAPA) and assist in their timely implementation.</li><li>
Participate in audit program, including planning, training, management of audit reports, communication of deficiencies and follow up of action items</li><li>
Assist in the assessment, development and implementation of the training program; identify improvement areas and processes for training.</li><li>
Plan and implement educational in-services to improve staffs' knowledge of their direct activities and understanding of the wider aspects of Cord Blood Banking, Transplantation and cord derived cellular therapies.</li><li>
Support the electronic submission of required documentation for accreditation, licensing and post marketing activities such as clinical outcome data, change, biological product deviations and adverse experiences, including but not limited to FDA Biologics Licensure Application (BLA), Investigational New Drug (IND) applications, CAP, and FACT.</li></ul><br>
Other duties as assigned.<br>
<br>
Why Join MD Anderson
<br>
<ul><li>Join an organization known for excellence, innovation, and high standards.</li><li>
Work in a collaborative environment that values quality and continuous improvement.</li><li>
Develop skills across compliance, training, and operational oversight.</li><li>
Contribute to processes that support safe, effective clinical work.</li><li>
Be part of a mission-driven team focused on meaningful patient impact.</li></ul><br>
<br>
<br>
<b>EDUCATION</b><br>
<br>
Required: Bachelor's degree.<br>
<br>
Preferred:Master's degree.<br>
<br>
<b>EXPERIENCE</b><br>
<br>
Required: Five years of relevant experience. With Master's degree, three years of required experience required.<br>
<br>
Preferred: Experience with HCT/Ps in a quality control, quality assurance, or regulatory role. Experience manufacturing or testing clinical cellular therapy products. Experience in blood or tissue banking.<br>
<br>
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.<br>
<br>
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.<br>
<br>
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html<br>
<br>
Additional Information
<br>
<ul><li>Requisition ID: 179387
</li><li>Employment Status: Per Diem
</li><li>Employee Status: Regular
</li><li>Work Week: Day/Evening, Days, Evenings, Varied, Weekends
</li><li>Minimum Salary: US Dollar (USD) 88,200
</li><li>Midpoint Salary: US Dollar (USD) 110,500
</li><li>Maximum Salary : US Dollar (USD) 132,300
</li><li>FLSA: exempt and not eligible for overtime pay
</li><li>Fund Type: Soft
</li><li>Work Location: Hybrid Onsite/Remote
</li><li>Pivotal Position: Yes
</li><li>Referral Bonus Available?: Yes
</li><li>Relocation Assistance Available?: Yes
</li></ul><br>
#LI-Hybrid</div>

Cell Therapy QA Specialist IV ( Per Diem )

Houston Methodist

<div>At Houston Methodist, the Clinic Coordinator is a multifaceted clinic based role which, in conjunction, with management, organizes the daily activities of the clinic ensuring provider support, patient experience, advanced and complex clinic/administrative tasks, to support clinic flow. This position works to create the best possible working environment for patients, providers, staff, and management. The incumbent may also be required to perform scheduling activities (this might include appointments, procedures, and/or surgeries), ensure medical necessity compliance, and verify eligibility for care. Other duties for the Clinic Coordinator position include independently and expertly performing the duties and responsibilities of preceptor and clinical resource to Medical Assistants, for training and orienting others as appropriate; organizing and directing all aspects of the daily clinic operations to support and maintain organizational and departmental policies and procedures. Additionally, the Clinic Coordinator will provide training and oversight in the pursuit of unparalled safety, quality, service, education, and innovation to our patients.
<div><b>FLSA STATUS</b><br>
Non-exempt<br>
<br>
<b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
High School diploma or equivalent education (examples include: GED, verification of homeschool equivalency, partial or full completion of post-secondary education, etc.)
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Five years as a Senior/Advanced Medical Assistant
</li><li>Two years demonstrated leadership experience (i.e., mentor, quality control, or clinical process improvement) preferably in health care required
</li><li>One year Training experience preferred
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Required</b><ul><li>
BLS - Basic Life Support or Instructor (AHA) - American Heart Association <b>and</b></li><li>
Must have Medical Assistant Certification CMA from NAHP, NCCT, NHA, AAMA. or RMA from AMT or CCMA from NHA
</li></ul><b>Preferred</b><ul><li>
CPT &ndash; Certified Phlebotomy Technician (ACA)
</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>Must be EPIC proficient.
</li><li>Knowledge of medical practice and care of patients and ability to assist with examinations, diagnostic and treatment procedures, knowledge of medical equipment and instruments
</li><li>Skill in developing and maintaining clinical quality assurance to maintain accurate medical records
</li><li>Demonstrates a learning attitude toward solving problems, using good reasoning and judgment
</li><li>Provides safe patient-centered, compassionate and competent care
</li><li>Proficient in computer skills for documentation and work-related purposes
</li><li>Completes required continuous training and education, including department-specific requirements. Maintain current certifications
</li><li>Ability to establish and maintain effective working relationships with patients, medical staff, co-workers and the public
</li><li>Ability to work with peers in a team situation
</li><li>Possesses an understanding of the patient population as it relates to the clinical disease process
</li><li>Proficient in computer skills for documentation and work-related purpose
</li>Demonstrates advanced assessment competences appropriate for level of practice<br>
<li>
</li></ul><br>
<br>
<b>ESSENTIAL FUNCTIONS</b><br>
<br>
<b>PEOPLE ESSENTIAL FUNCTIONS</b><ul><li>
Coordinates patient flow, obtaining patient demographics as needed, preparing patient for provider/mid-level visit and provides back up to clinic staff.
</li><li>Organizes daily schedules and work activities; providing coverage to meet patient needs.
</li><li>Assists with triage, patient prescription, re-fills and referrals, and prescription education. Independently executes the duties and responsibilities of preceptor, serves as a clinical resource in the department, using advanced skills and competencies, guiding and mentoring colleagues though processes in order to provide optimal patient care. Provides structured feedback with examples.
</li><li>Works with clinical management to assess and determine process protocols for clinic and conducts meeting with clinic staff and Practice Manager
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Demonstrates engagement in planning, organizing, and directing all aspects of clinic operations. Collaborate with leadership, other clinics, and Medical Assistants to develop new processes and/or procedures for continued patient care.
</li><li>Provides quality oversight for documentation of vital signs, chief complaint(s), preforms medication(s) review, and discusses/reviews medical and social history (as appropriate). Documents, in patient&rsquo;s electronic medical record (EMR) care administered, all diagnostic measurements, treatments, and procedures in accordance with established policies.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Interprets documents such as provider orders, safety rules, operating and maintenance instructions and procedure manuals. Follows-up with patient as appropriate to ensure compliance with recommendations, medications, lab/x-ray results, special visits, PCP visits, dieticians, diabetes educators, etc. Ensures patient utilization and activation of MyChart.
</li><li>Provides initial investigation and information for internal and external complaints to management.
</li><li>Provides care coordination with hospital, ED, consulting physicians and/or community resources whenever appropriate to include handling patient inquiries.
</li><li>Role models behaviors and skills, through peer-to-peer accountability, towards improving department score for patient satisfaction.
</li><li>Leads efforts, in collaboration with clinic management, to assure that Environment of Care rounds are performed monthly in the clinic setting
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Provides oversight of clinic resources to align with clinic budgetary goals and objectives; assists in long range planning of clinic needs.
</li><li>Arranges for pre-authorizations and pre-certifications of procedures as needed.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Participates in curriculum development for Graduate Medical Assistant staff. Provides development and guidance for new clinical employees.
</li>Collaborates with clinic management on process improvement.<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): No
</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 Yes
</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>
High School diploma or equivalent education (examples include: GED, verification of homeschool equivalency, partial or full completion of post-secondary education, etc.)
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
Five years as a Senior/Advanced Medical Assistant
</li><li>Two years demonstrated leadership experience (i.e., mentor, quality control, or clinical process improvement) preferably in health care required
</li><li>One year Training experience preferred
</li></ul><br>
<b>LICENSES AND CERTIFICATIONS</b><br>
<b>Required</b><ul><li>
BLS - Basic Life Support or Instructor (AHA) - American Heart Association <b>and</b></li>
<li>Must have Medical Assistant Certification CMA from NAHP, NCCT, NHA, AAMA. or RMA from AMT or CCMA from NHA
</li></ul><b>Preferred</b>
CPT &ndash; Certified Phlebotomy Technician (ACA)<br>
<ul><li>
</li></ul><br>
<p><b>Company Profile:</b></p><p>
Houston Methodist Specialty Physician Group is an integral part of Houston Methodist&rsquo;s overall strategy to become one of the nation&rsquo;s leading academic medical centers. Established as a nonprofit corporation certified by the Texas State Board of Medical Examiners, the Specialty Physician Group enables physicians to maintain autonomy with respect to clinical practice while growing their practice within an academic environment.</p><p>
Houston Methodist is an Equal Opportunity Employer.</p></div>

Clinical Coordinator - Orthopedics (Medical Center)

<div>Seeking a<b> Research Nurse</b> to join one of the world's most respected centers devoted exclusively to cancer patient care, research, education and prevention. The Department of Thoracic/Head and Neck Medical Oncology provides the highest quality of care to our patients and advances the treatment and prevention of aerodigestive cancers through innovative clinical and laboratory research.<br>
<br>
<b>The ideal candidate will have prior Oncology research experience. Candidates must be willing to be onsite for 4 days a week for the first 6 months. The schedule for this position is Monday - Friday, 8:00am - 5:00pm.</b><br>
<br>
<b>MD Anderson offers employees:
</b><br>
<ul><li>Paid employee medical benefits (zero premium) starting on first day for employees who work 30 or more hours per week.</li><li>Group Dental, Vision, Life, AD&amp;D and Disability coverage.</li><li>Paid time off (PTO) and Extended Illness Bank (EIB) paid leave accruals.</li><li>Paid institutional holidays, wellness leave, childcare leave, and other paid leave programs.</li><li>Tuition Assistance Program after six months of service.</li><li>Teachers Retirement System defined-benefit pension plan and two voluntary retirement plans.</li><li>Employer paid life, AD&amp;D and an illness-related reduced salary pay program.</li><li>Extensive wellness, recognition, fitness, employee health programs and employee resource groups.</li><li>Opportunities for professional growth through Career Development Center and Mentoring programs.</li></ul><br>
We have been named one of the top two hospitals in cancer care every year since U.S. News &amp; World Report began its annual rankings in 1990.<br>
As one of the largest cancer centers in the world, MD Anderson remains committed to the highest standards for research-driven patient care and to providing quality education and training for the next generation of medical professionals.<br>
<br>
<b>KEY FUNCTIONS</b><br>
<ul><li>Protocol Management and enrolling patients onto clinical trials.</li><li>Review of protocol related materials and participating in site initiation meetings and other pre-activation meetings/trainings.</li><li>Review of patient eligibility criteria and related documentation in the patient's medical record.</li><li>Ordering and obtaining appropriate laboratory tests/procedures and results.</li><li>Patient education and managing communication of materials related to investigational agents provided as treatments on clinical trials.</li><li>Obtaining informed consent from patients, attending physicians and family members.</li><li>Meet with the sponsor and principal investigator (PI) to discuss ongoing issues with patients on study.</li><li>Responsible for adverse event and safety reporting to the PI, internal/eternal IRBs and FDA.</li><li>Collection of protocol related data and documentation to be entered into protocol-specific databases.</li><li>Participate in all monitoring and auditing activities to maintain quality assurance.</li><li>Training and mentoring research nurses and other clinical research team members and new hires, as it relates to identifying needs, onboarding and providing educational opportunities and developing research documents and tools.</li></ul><br>
<b>
EDUCATION</b><br>
<ul><li>Required: Graduation from an accredited school of professional nursing.</li><li>Preferred: Bachelor's Degree Nursing.</li></ul><br>
<b>
WORK EXPERIENCE</b><br>
<ul><li>Required: 1 year Registered nurse experience.</li><li>Preferred: Prior Research Nurse and/or Oncology experience.</li></ul><br>
<b>
LICENSES AND CERTIFICATIONS</b><br>
<ul><li>Required: RN - Registered Nurse - State Licensure Current State of Texas Professional Nursing license (RN). Upon Hire
</li><li>Required: BLS - Basic Life Support or CPR - Cardiac Pulmonary Resuscitation Upon Hire</li><li>Preferred: ACLS - Advanced Cardiac Life Support Certification as required by patient care area. Upon Hire</li><li>Preferred: PALS - Pediatric Advanced Life Support Certification as required by patient care area. Upon Hire</li></ul><br>
The University of Texas MD Anderson Cancer Center offers excellent benefits, including medical, dental, paid time off, retirement, tuition benefits, educational opportunities, and individual and team recognition.<br>
<br>
This position may be responsible for maintaining the security and integrity of critical infrastructure, as defined in Section 113.001(2) of the Texas Business and Commerce Code and therefore may require routine reviews and screening. The ability to satisfy and maintain all requirements necessary to ensure the continued security and integrity of such infrastructure is a condition of hire and continued employment.<br>
<br>
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state, or local laws unless such distinction is required by law.http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html<br>
<br>
Additional Information
<br>
<ul><li>Requisition ID: 179271
</li><li>Employment Status: Full-Time
</li><li>Employee Status: Regular
</li><li>Work Week: Days
</li><li>Minimum Salary: US Dollar (USD) 77,500
</li><li>Midpoint Salary: US Dollar (USD) 97,000
</li><li>Maximum Salary : US Dollar (USD) 116,500
</li><li>FLSA: exempt and not eligible for overtime pay
</li><li>Fund Type: Soft
</li><li>Work Location: Hybrid Onsite/Remote
</li><li>Pivotal Position: Yes
</li><li>Referral Bonus Available?: Yes
</li><li>Relocation Assistance Available?: Yes
</li></ul><br>
#LI-Hybrid</div>

Research Nurse - Thoracic Head & Neck Medical Oncology

Explore 1130+ Clinical research senior quality assurance and control associate in Houston this March. Find roles across top companies and apply now to boost your career.