clinical research coordinator 1 yr. exp req.

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cardiology medical assistant

clinical research coordinator Jobs in Houston

clinical research coordinator

clinical research coordinator 1 yr. exp req. Jobs in Houston

clinical research assistant

UTHealth Houston

<div><p>This position will work in the Trainor Lab in the Department of Pediatrics, Pediatric Research Center. The Pediatric Research Center is home to wide-ranging research focused on identifying the causes of birth defects with the ultimate goal of developing prevention and treatment strategies.</p><p>
The Research Assistant III will independently perform complex laboratory experiments to investigate the molecular and cellular mechanisms underlying craniofacial development and congenital birth defects. The individual will maintain accurate research records, analyze experimental data, assist with manuscript and grant preparation, and contribute to the day-to-day operations of a collaborative basic science research laboratory.</p><p><b>
Preferred Qualifications:</b></p><ul><li><p>
Experience in developmental biology, genetics, molecular biology, cell biology, or embryology research, preferably using vertebrate animal models (e.g., mouse, zebrafish, or chick embryos)</p></li><li><p>
Proficiency with advanced laboratory techniques such as PCR, genotyping, DNA/RNA extraction, tissue processing, microscopy/imaging, immunohistochemistry, and maintaining accurate research records; experience contributing to manuscripts or grant preparation is preferred.</p></li><li>
Demonstrated ability to work independently while collaborating effectively in a multidisciplinary research environment, with strong organizational, communication, problem-solving, and mentoring skills.</li></ul><p><b>
What we do here changes the world.</b> UTHealth Houston is Texas&rsquo; resource for healthcare education, innovation, scientific discovery, and excellence in patient care. That&rsquo;s where you come in.</p><p><b>
Once you join us you won't want to leave.</b> It&rsquo;s because we reward our team for the excellent service they provide. Our total rewards package includes the benefits you&rsquo;d expect from a top healthcare organization (benefits, insurance, etc.), plus:</p><ul><li>
100% paid medical premiums for our full-time employees</li><li>
Generous time off (holidays, preventative leave day, both vacation and sick time &ndash; all of which equates to around 37-38 days per year)</li><li>
The longer you stay, the more vacation you&rsquo;ll accrue!</li><li>
Longevity Pay (Monthly payments after two years of service)</li><li>
Build your future with our awesome retirement/pension plan!</li></ul><p><b>
We take care of our employees!</b> As a world-renowned institution, our employees&rsquo; wellbeing is important to us. We offer work/life services such as...</p><ul><li>
Free financial and legal counseling</li><li>
Free mental health counseling services</li><li>
Gym membership discounts and access to wellness programs</li><li>
Other employee discounts including entertainment, car rentals, cell phones, etc.</li><li>
Resources for child and elder care</li><li>
Plus many more!</li></ul><p><b>
Position Summary:</b></p><p>
Under minimal direction of senior research staff, conducts and executes complex basic science/ translational experiments and research tasks and assists in the interpretation of the results.</p><p><b>
Position Key Accountabilities:</b></p><ul><li>
Under minimal supervision, implements planned research experiments according to research protocol.</li><li>
Maintains accurate and timely records which may include notebooks, records, databases, etc. as needed by the research project. May assist in the preparation and writing of research reports, manuscripts, papers, and grant proposals for presentation and publication.</li><li>
Maintains clean laboratory equipment and/or work area to ensure a safe and efficient work environment.</li><li>
Monitors laboratory and/or other supplies to ensure sufficient inventory to support research projects. Ensures quality of reagents or other supplies.</li><li>
Stays abreast of new and updated procedures and protocols for research laboratory. Must complete required training. May participates in continuing education programs, seminars, and workshops.</li><li>
May provide guidance and training for support staff to ensure efficient, timely and high-quality results.</li><li>
May provide updates to Principal Investigator regarding research progress.</li><li>
Makes independent decisions as required, which may impact research team or assigned project.</li><li>
Performs other duties as assigned.</li></ul><p><b><br>
Certification/Skills:</b></p><ul><li>
None</li></ul><p><b>
Minimum Education:</b></p><p>
Bachelor's Degree required<br>
May substitute required education with equivalent years of experience beyond the minimum experience requirement.</p><p><b>
Minimum Experience:</b></p><p>
Two (2) years of related experience in a research or clinical lab environment<br>
May substitute required experience with equivalent years of education beyond the minimum education requirement.</p><p><b>
Physical Requirements:</b></p>
Exerts up to 20 pounds of force occasionally and/or up to 10 pounds frequently and/or a negligible amount constantly to move objects.<p><b>
Security Sensitive:</b></p>
This position is a security-sensitive position pursuant to Texas Education Code &sect;51.215 and Texas Government Code &sect;411.094. To the extent that a position requires the holder to research, work on, or have access to critical infrastructure as defined in Texas Business and Commerce Code &sect;117.001(2), the ability to maintain the security or integrity of the infrastructure is a minimum qualification to be hired for and to continue to be employed in that position. Personnel in such positions, and similarly situated state contractors, will be routinely reviewed to determine whether things such as criminal history or continuous connections to the government or political apparatus of a foreign adversary might prevent the applicant, employee, or contractor from being able to maintain the security or integrity of the infrastructure. A foreign adversary is a nation listed in 15 C.F.R. &sect;791.4.<p><b>
Residency Requirement:</b></p><p>
Employees must permanently reside and work in the State of Texas.</p></div>

Research Assistant III - Pediatrics

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Michael E. DeBakey Department of Surgery at the Baylor College of Medicine (BCM) seeks a highly qualified individual with a PhD and postdoctoral experience in Computer Science, Data Science, Medical Informatics or Equivalent Field. The Assistant Professor &ndash; Data Scientist would serve as scientific lead with Dr. Ravi Ghanta, overseeing the Department of Surgery ATLAS AI program to develop innovative AI applications in surgery and healthcare. The work spans AI applications in healthcare including machine vision, robotics, image analysis, natural language processing, and predictive modeling.</p><p></p><p><br>
Under this role, the Assistant Professor will work with a team of post-doctoral computer scientists and engineers on NIH-funded research projects. The Assistant Professor is expected to oversee data engineering of electronic health data for machine learning applications, interoperability with electronic health record (EHR) systems, and evaluation of algorithm predictive performance. The Assistant Professor will interact directly with postdoctoral fellows, graduate students, and medical students.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Oversee and coordinate logistics and execution of various research projects.</li><li>
Manage project progress and execution of project goals and milestones.</li><li>
Plan and direct research experiments.</li><li>
Organize, evaluate, and analyze data with other researchers.</li><li>
Develop research techniques and perform applications required for specific research projects.</li><li>
Conduct literature searches and summarize information in an appropriate format for a particular study.</li><li>
Document results of experiments and reports to principal investigators.</li><li>
Supervise, schedule and coordinate the activities of the research team involved in multiple research projects.</li><li>
Write progress reports, manuscripts and grant proposals.</li><li>
Lead clinical studies and participate in research involving human subjects. Interact directly with clinicians, surgeons, and pathologists to fulfill the aims of the research projects.</li><li>
Supervise research staff including graduate and undergraduate students.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Ph.D. in computer science, data science, medical informatics, or related field.</li><li>
Successful track record of collaboration with clinical investigators and in interdisciplinary teams; accomplished academic record sufficient to fulfill criteria for an assistant professor level faculty appointment at Baylor College of Medicine.</li></ul></div></div></div><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div><p></p>

Assistant Professor - Artificial Intelligence and Data Scientist

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
Baylor College of Medicine, in partnership with the Department of Pathology at Texas Children's Hospital, is seeking an Instructor - Pathologists Assistant. This role is responsible for the gross examination and dissection of surgical specimens, submission of tissue for histologic evaluation, and preparation of detailed specimen documentation.</p><p></p><p><br>
In addition, the Pathologists Assistant supports Tumor Bank and special study initiatives through tissue collection and specimen tracking, assists with quality assurance and billing-related activities, and provides education and guidance to residents and students on pathology procedures and laboratory techniques.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><p>
Clinical Responsibilities (60%):</p><ul><li>
Surgical Specimen Examination and Dissection</li><li>
Performs gross examination, dissection, and triage of surgical specimens in accordance with departmental policies, CAP guidelines, and pathology protocols.</li><li>
Selects and submits appropriate tissue for histologic review, ancillary studies, and specialized testing.</li><li>
Dictates accurate, detailed gross descriptions and verbal reports documenting specimen findings.</li><li>
Supports intraoperative consultations, including tissue selection, slide preparation, and cutting.</li><li>
Provides procedure support, including cytologic smear preparation, procedure setup, and glomerular assessment.</li><li>
Instructs and supervises trainees.</li><li>
Autopsy Prosection</li><li>
Performs complete autopsy prosection</li><li>
Orders cultures and other approved ancillary studies per attending physician direction.</li></ul><p></p><p><br>
Tissue Collection, Biobanking &amp; Research Support (15%):</p><ul><li>
Collects, prepares, documents, and catalogs fresh tissue specimens for institutional and specialty biobanks (e.g., Tumor Bank, PeriBank, Cardiology, Urologic, Gynecologic, and &quot;Normal&quot; Tissue repositories).</li><li>
Performs specimen dissection and photography for faculty research and manuscript preparation.</li><li>
Supports data collection and analysis for research projects and publications.</li><li>
Ensures proper specimen handling, labeling, and documentation to maintain quality, regulatory compliance, and research integrity.</li></ul><p></p><p><br>
Quality Assurance, Billing &amp; Administrative Support (15%):</p><ul><li>
Prepares quality assurance reports and supports departmental quality improvement initiatives.</li><li>
Reviews and revises CPT charge codes and obtains A charges for international patient cases to ensure accurate billing.</li><li>
Maintains and manages clinical databases.</li><li>
Serves as an Epic Beaker user with knowledge of accessioning and grossing workflows; assists with system builds and upgrades.</li><li>
Develops, reviews, and maintains grossing protocols in alignment with CAP and institutional standards.</li><li>
Supports LEAN implementation and process improvement initiatives.</li><li>
Provides expertise and administrative oversight for dictation software, including access management and user training.</li></ul><p></p><p><br>
Education &amp; Training (5%):</p><ul><li>
Provides hands on instruction and mentorship to pathology residents, fellows, students, and trainees across all clinical duties.</li><li>
Serves as a clinical liaison with operating room personnel, nursing staff, and other interdisciplinary teams.</li><li>
Participates in continuing education and laboratory management training (e.g., ASCP courses).</li></ul><p></p><p><br>
Additional Responsibilities (5%):</p><ul><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>
NAACLS accredited program OR bachelor&rsquo;s degree in a related field AND grandfathered through ASCP options (pre-2010) channels with both avenues resulting in earning and maintaining a PA(ASCP) certification.</li><li>
Pre-2010 Exception: Pathologists' Assistants who attained ASCP certification prior to 2010 via a 3-year supervised internship (instead of a master's degree program) are legally recognized as holding the exact same qualifications as NAACLS program-trained individuals.</li><li>
Credentials: Both program-trained and grandfathered individuals who successfully passed the ASCP exam are authorized to use the credential PA(ASCP).</li></ul></div></div></div><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div><p></p>

TCH Pathology (Instructor)

Houston Methodist

<div>At Houston Methodist, the Clinical Research Specialist position is responsible for supporting multiple projects under supervision of Clinical Trial Manager which may include clinical research protocols, gathering patient data via methods specified in the study protocol, study reports. This position ensures accurate data collection, documentation organization, and safety of study volunteers.
<div><b>FLSA STATUS</b><br>
Exempt<br>
<br>
<b>QUALIFICATIONS</b><br>
<br>
<b>EDUCATION</b><ul><li>
Bachelor&rsquo;s degree in a related field
</li><li>Bachelor's Degree in a Health-Science related field preferred
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
One year experience in healthcare setting preferred
</li><li>Research setting preferred
</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>Exhibits good listening skills
</li><li>Ability to work independently and analyze and solve problems
</li><li>Demonstrates the ability to manage clinical and interpersonal situations
</li><li>Able to prioritize tasks and manage multiple projects
</li>Self-motivated with the ability to think critically and work independently<br>
<li>
</li></ul><br>
<br>
<b>ESSENTIAL FUNCTIONS</b><br>
<br>
<b>PEOPLE ESSENTIAL FUNCTIONS</b><ul><li>
Supports the inter-professional team of clinical research investigators, nurses and coordinators. Promotes a positive work environment and contributes to a dynamic, team-focused work unit that actively helps one other to achieve optimal department results.
</li><li>Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.
</li></ul><br>
<b>SERVICE ESSENTIAL FUNCTIONS</b><ul><li>
Performs clinical research support functions as assigned by the clinical trial manager including but not limited to informed consent for non-interventional studies, data abstraction and recording in CRFs.
</li><li>Makes phone calls to study patients for appointment reminders and follow-up.
</li><li>Transports blood and tissue samples. Processes and packages lab samples for shipping to sponsor or storage at site per the study manual of operations.
</li></ul><br>
<b>QUALITY/SAFETY ESSENTIAL FUNCTIONS</b><ul><li>
Completes required case report forms and resolves queries. Ensures accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing.
</li><li>Assists Clinical Trial Manager in identifying opportunities research workflow process improvement, providing recommendations, and contributes to meeting department and hospital targets for quality and safety.
</li></ul><br>
<b>FINANCE ESSENTIAL FUNCTIONS</b><ul><li>
Assures study conduct meets appropriate IRB, FDA, ICH and agency guidelines.
</li><li>Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed.
</li></ul><br>
<b>GROWTH/INNOVATION ESSENTIAL FUNCTIONS</b><ul><li>
Assist in simple data analysis, with development of training materials for data reports, systems and collection and report generation.
</li><li>Leads and identifies opportunities for performance improvement. Supports change initiatives and adapts to unexpected changes.
</li>Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.<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: Yes
</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>
Bachelor&rsquo;s degree in a related field
</li><li>Bachelor's Degree in a Health-Science related field preferred
</li></ul><br>
<b>EXPERIENCE</b><ul><li>
One year experience in healthcare setting preferred
</li>Research setting preferred<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>

Clinical Research Specialist

<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

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

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