clinical care coordinator - pedi cv surgery

clinical nurse coordinator rn operating room

clinical research coordinator 1 yr. exp req.

coordinator, business operations Jobs in Houston

coordinator, business operations

clinical care coordinator - pedi cv surgery Jobs in Houston

clinical nurse coordinator Jobs in Houston

clinical nurse coordinator

clinical nurse coordinator rn operating room Jobs in Houston

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

clinical research coordinator

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

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

Research Coordinator II

Baylor College of Medicine

<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

UTHealth Houston

<div><p>The Research Coordinator I/II supports the conduct of NIH-, industry-, and investigator-initiated research studies within the Neonatal Intensive Care Unit (NICU). This role assists with the day-to-day implementation of ongoing and future studies, including participation in the NICHD Neonatal Research Network.</p><p>
The position is primarily weekday based, with flexibility to accommodate patient screening and consent activities, including occasional weekend or &quot;on call&quot; hours approximately every two months. This role participates in a team-based call rotation to support ongoing enrollment and study needs.</p><p><b>
Key responsibilities </b>include supporting study operations, assisting with coordination of research activities, and serving as a point of communication between clinical and research teams. The role contributes to study execution by screening and consenting parents of eligible infants, collecting and entering study data, and supporting specimen processing as needed.</p><p>
The Research Coordinator is responsible for maintaining accurate and timely study documentation, tracking assigned tasks and study activities, and ensuring work is completed in accordance with protocol and regulatory requirements. This includes supporting data quality efforts, preparing for monitoring visits, and assisting with regulatory documentation and submissions (e.g., IRB-related materials).</p><p><b>
Preferred Skills/Qualifications:</b></p><ul><li><p>
Experience with clinical research in a NICU or inpatient settings. Working with a multidisciplinary healthcare team is preferred.</p></li><li><p>
Experience with patient/family interaction, screening, enrollment, and informed consent processes.</p></li><li><p>
 Knowledge of clinical research regulations, including IRB processes, and FDA requirements.</p></li><li><p>
CITI Certifications (GCP, Human Subjects Research, CRC Foundations, CRC Advanced).</p></li><li><p>
Familiarity with REDCap, EPIC, Beacon, Medidata, or similar data systems.</p></li><li><p>
Bilingual (English/Spanish).</p></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>
Assists with human subject research project conduct and management, including participant recruitment and data collection, entry, management, and analysis. Assists with research project logistics, maintaining records, preparing reports, and meeting research milestones and deadlines.</p><p><b>
Position Key Accountabilities:</b></p><ul><li>
Under supervision, assists with human subjects research activities, including participant recruitment, informed consent, data collection through surveys, interviews, observations, and ensuring that all activities are conducted according to study protocols.</li><li>
Organizes, cleans, and maintains databases to ensure accurate data entry and preparation for analysis under close supervision.</li><li>
Maintains confidential records of collected data and ensures accuracy, compliance, and integrity of data. Data may include human subject data and departmental programmatic data. Supports Data Management Sharing (DMS) plan.</li><li>
Prepares annual progress reports and applications for various committees and ensures that all staff have received the proper training/attended the appropriate training courses.</li><li>
Assists in the preparation of progress and annual reports and grant proposals to various funding agencies; works closely with the Office of Sponsored Projects on the submission of grants.</li><li>
May assist with regulatory submissions (i.e. Institutional Review Board(s), FDA, etc).</li><li>
Assist investigator with quantitative and qualitative data analysis, including the creation of figures, tables, and graphs. Helps prepare research papers, presentations, and reports including academic publications and conferences.</li><li>
Conduct reviews of academic journals and databases to gather relevant articles and publications as directed to help prepare manuscripts for publication.</li><li>
Assists with the preparation of budgets and reviews re-budgeting needs and expenditures. Attends research-planning meetings to assist in preparing budget drafts for departmental leadership approval. Assists with invoicing.</li><li>
Assists in preparing for and responding to site monitoring visits, audits, and inspections.</li><li>
May be responsible for maintaining study materials (i.e. test kits, investigational drugs and devices).</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 in a related field required May substitute required education with equivalent years of experience beyond the minimum experience requirement.</p><p><b>
Minimum Experience:</b></p><p>
Research Coordinator I - None</p><p>
Research Coordinator II - 2 years of relevant experience required May substitute required experience with equivalent years of education beyond the minimum education requirement.</p><p><b>
Physical Requirements:</b></p><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><p><b>
Security Sensitive:</b></p><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><p><b>
Residency Requirement:</b></p><p>
Employees must permanently reside and work in the State of Texas.</p></div>

Research Coordinator I/II - Pediatrics

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

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