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clinical research coordinator

American Oncology Network

<div>Location:
Oncology Consultants - Medical Center CCO Office
Pay Range:
$19.66 - $34.59<h1 class="jobSectionHeader">
Job Description Summary</h1>
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basics tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level
Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume 2-10 annually.
Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.<h1 class="jobSectionHeader">
Primary Key Performance Areas</h1>
KPA 1 &ndash; Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.<ul><li>
Identify and explain key protocol elements and perform study tasks under direct supervision</li><li>
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires</li><li>
Identifies and explains inclusion/exclusion criteria and the process of subject identification, prescreening, screening and re-screening</li><li>
Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process.</li><li>
Review of diagnostic tests and related documentation required per protocol</li><li>
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Document different types of adverse events under direct supervision</li><li>
Ensures proper storage, dispensing, handling and destruction processes for investigational products.</li><li>
Follows process for handling investigational products that have been compromised.</li></ul>
KPA 2 &ndash; Regulatory and Data Integrity<ul><li>
Follows Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site. Maintains site credentials and ensures updated GCP, licenses remain on file
</li><li>Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.</li><li>
Collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient&rsquo;s medical record for completeness and accuracy under direct supervision</li><li>
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials</li><li>
Prepare documents for monitoring visits under direct supervision. Review visit monitoring follow-up reports / letters and perform requested activities.</li><li>
Escalates issues of protocol non-compliance to study PI and research department leadership</li></ul>
KPA 3 &ndash; Research Financial Practices: Budget/Contract execution and practices research billing compliance
<ul><li>Identifies elements of a study budget as it relates to execution of a protocol.</li></ul><h1 class="jobSectionHeader">
Position Qualifications/Requirements</h1>
Education<ul><li>
High school education required</li><li>
Some college is preferred</li></ul>
Previous Experience<ul><li>
Prior research or related medical science experience</li></ul>
Core Capabilities<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li></ul>
Computer Skills<ul><li>
Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul><h2 class="jobSectionHeader">
Travel: 0%</h2>
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM.</div>

Clinical Research Coordinator

Johnson County Clin Trials (JCCT)

<div>
 
 Description
 
 
 
 
 Clinical Research Coordinator II
 
 
 
 
 Purpose
 
 
 
 The purpose of the Clinical Research Coordinator II role is to ensure the successful execution of multiple concurrent clinical trials through effective study coordination, subject management, and cross-functional communication. This position serves as a primary liaison between investigators, study teams, sponsors, and clinical staff to maintain protocol compliance, uphold regulatory and documentation standards, and support the integrity and quality of clinical research activities. By applying advanced knowledge of study protocols, strong organizational skills, and sound judgment, the Clinical Research Coordinator II contributes to the timely, efficient, and high-quality conduct of clinical studies that advance research objectives and improve patient outcomes.
 
 
 
 Position Summary
 
 
 
 The Clinical Research Coordinator II is responsible for the coordination and administration of overlapping clinical studies. Serves as the main point of contact for sponsors for assigned trials. The Study Coordinator will perform diverse administrative duties requiring analysis. The position requires sound judgment and a high-level knowledge of study specific protocols. The primary skills include logical thinking, ability to prioritize, &ldquo;can-do&rdquo; attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. This position reports to the Site Manager or Site Director.
 
 
 
 Key Responsibilities (Essential Functions)
 
 
 
 <ul>
 <li>
 Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities.
 </li>
 <li>
 Manage multiple concurrent trials
 </li>
 <li>
 Assist with mentoring and training study team members
 </li>
 <li>
 Maintain required records of study activity including study logs, case report forms, and/or regulatory forms
 </li>
 <li>
 Schedule volunteers for appointments, procedures and inpatient stays as required by study protocols
 </li>
 <li>
 Assess eligibility of potential volunteers through methods such as subject interviews, reviews of medical records, and discussions with Investigators and Research Associates
 </li>
 <li>
 Communicate with the Laboratory and/or Investigators regarding Lab procedures and/or findings
 </li>
 <li>
 Educate study volunteers on study procedures such as diary completion, electronic devices and expected outcomes in a profession and accountable manner following protocol requirements.
 </li>
 <li>
 Responsible for assuring training and documentation is completed for protocol amendments, ICFs, updated guidelines, etc.
 </li>
 <li>
 Communicate with Nursing staff (if applicable) on an ongoing basis regarding study updates, amendments/ changes.
 </li>
 <li>
 Communicate with Investigators on an ongoing basis regarding study progress, safety issues and other important information.
 </li>
 <li>
 Maintain contact with sponsors/CROs and respond in a timely manner as well as schedule/ coordinate site visits.
 </li>
 <li>
 Professional communication and collaborative work ethics with CRAs at Site visits.
 </li>
 <li>
 Order and track supplies or devices necessary for study completion.
 </li>
 <li>
 Prepare study-related source documentation according to protocol and system guidelines and work with QA department collaboratively to make appropriate changes.
 </li>
 <li>
 Record adverse events and discuss with Investigators regarding the reporting of events to oversight agencies.
 </li>
 <li>
 Track enrollment status of volunteers and documentation in Clinical Conductor system.
 </li>
 <li>
 Perform specific protocol procedures such as interviewing volunteers, taking vital signs, and performing electrocardiograms, etc.
 </li>
 <li>
 Prepare for or participate in quality assurance audits conducted by sponsors, federal agencies or specially designated review groups
 </li>
 <li>
 Collect, process and ship laboratory specimens
 </li>
 <li>
 Adherent to safety and privacy regulations
 
 
 </li>
 </ul>
 
 Education And Experience
 
 
 
 <ul>
 <li>
 BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
 </li>
 <li>
 Minimum 3 years of experience coordinating clinical trials, including the activities listed above
 </li>
 <li>
 Previous nursing, medical assistant experience in a clinical setting a plus
 </li>
 <li>
 CCRC certification a plus
 </li>
 <li>
 Demonstrated relationship building, with strong verbal and written skills.
 </li>
 <li>
 Ability to successfully coordinate protocols with overlapping timelines
 </li>
 <li>
 Ability to explain importance of GCP guidelines and their application
 </li>
 <li>
 Ability to train others on coordinating responsibilities and protocol adherence
 </li>
 <li>
 Able to follow clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
 </li>
 <li>
 Strong interpersonal skills with attention to detail a must
 </li>
 <li>
 Proven ethical and professional codes of conduct
 </li>
 <li>
 Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.
 
 
 </li>
 </ul>
 
 Skills And Competencies
 
 
 
 <ul>
 <li>
 Excellent communication, interpersonal, analytical and problem-solving skills
 </li>
 <li>
 Microsoft Office Suite proficiency
 </li>
 <li>
 Bilingual Required (location specific): Proficiency in Spanish and English, including the ability to speak, read, and write in both languages
 </li>
 <li>
 Writing and verbal communication skills
 </li>
 <li>
 Strong study documentation skills in compliance with ALCOA+ preferred
 </li>
 <li>
 Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
 </li>
 <li>
 Ability to work effectively with a team
 </li>
 <li>
 Ability to prioritize and manage multiple projects simultaneously
 </li>
 <li>
 Time management skills
 </li>
 <li>
 Organizational skills
 </li>
 <li>
 Detail oriented with the ability to perform at a high level of accuracy
 </li>
 <li>
 Demonstrates strong critical thinking, problem solving skills
 </li>
 <li>
 Self-motivated
 </li>
 <li>
 Must be results oriented, multi-tasking, quick learner
 </li>
 <li>
 Ability to travel for site network support, audits and or attend investigator meetings, as required.
 
 
 </li>
 </ul>
 
 Physical Requirements
 
 
 
 The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
 
 
 <ul>
 <li>
 Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
 </li>
 <li>
 Ability to lift and/or move up to 20 pounds
 
 
 </li>
 </ul>
 
 
 Why JCCT?
 
 
 
 
 
 JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.
 
 
 
 
 We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.
 
 
 
 
 Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.
 
 
 
 
 If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!
 
 
 
 
 
 EEO
 
 
 
 
 
 JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
 
</div>

Clinical Research Coordinator II

MD Anderson Cancer Center

<div>The Research Data Coordinator role within Interventional Radiology in the Diagnostic Imaging Division at The University of Texas MD Anderson Cancer Center plays a key role in supporting clinical research studies that advance patient care and cancer discovery. This position focuses on coordinating research data, regulatory documentation, and patient-related activities in support of departmental clinical research protocols. The Coordinator works closely with investigators, research nurses, and clinical teams to ensure studies are conducted accurately, efficiently, and in compliance with institutional and regulatory requirements. 
 
The Research Data Coordinator contributes to the broader mission of UT MD Anderson by supporting high-quality research that integrates patient care, research, and education. UT MD Anderson is a leading institution focused on cancer care, research, education, and prevention. Through collaboration, integrity, and attention to detail, the Coordinator helps ensure that research studies are conducted safely, ethically, and with the highest standards of excellence. 
 
The ideal candidate for the Coordinator role has a strong foundation in administrative, scientific, or clinical support, with a preference for a bachelor's degree in Nursing or a related scientific or administrative field. The candidate brings at least two years of related experience or meets experience requirements through preferred education, demonstrates strong attention to detail, effective communication skills, and the ability to work independently while collaborating with multidisciplinary research and clinical teams. 
 
Why Us? 
 
The Research Data Coordinator role offers the opportunity to directly support UT MD Anderson's mission to eliminate cancer through meaningful contributions to clinical research and patient care. This position provides exposure to complex clinical trials, collaboration with expert clinical and research professionals, and opportunities for ongoing learning and professional growth in a mission-driven environment that values accountability, teamwork, and patient-centered care. 
 
<ul><li>Employer-paid medical coverage starting day one for employees working 30+ hours/week, plus optional group dental, vision, life, AD&amp;D, and disability insurance.</li><li>Accruals for PTO and Extended Illness Bank, plus paid holidays, wellness, childcare, and other leave options.</li><li>Tuition Assistance Program after six months of service and access to extensive wellness, fitness, and employee resource groups.</li><li>Defined-benefit pension through the Teachers Retirement System, voluntary retirement plans, and employer-paid life and reduced salary protection programs.</li></ul> 

Responsibilities 
 
Protocol Administration and Regulatory Coordination 
 
<ul><li>Assist in coordinating protocol administration and regulatory correspondence for assigned clinical research studies</li><li>Communicate verbally and in writing with internal reviewers and external agencies such as pharmaceutical sponsors and governmental sponsors</li><li>Complete forms and ensure compliance with institutional, state, and federal regulations for study initiation, conduct, and termination</li><li>Coordinate and send outgoing materials and correspondence to institutional, state, and federal agencies</li><li>Assist in preparing required reports for sponsoring agencies based on reporting schedules</li><li>Inform sponsors and collaborators of regulatory status during formal departmental protocol review meetings</li></ul> 
Data Collection and Management 
 
<ul><li>Review medical records to extract required clinical research data</li><li>Transfer patient information into electronic databases and case books</li><li>Maintain accurate and up-to-date patient flowsheets including toxicities, adverse events, follow-up visits, and dose modifications</li><li>Assist in preparing scheduled interim status reports using approved institutional or sponsor databases</li><li>Maintain organized reference and filing systems for protocols and related grants</li></ul> 
Patient and Clinical Team Support 
 
<ul><li>Answer and screen office phone calls in a professional manner</li><li>Triage patient calls to research nursing staff as appropriate</li><li>Coordinate patient appointment schedules in collaboration with clinical teams</li><li>Relay urgent or important patient messages promptly to research nurses and clinical research personnel</li><li>Assist with documenting and placing specimen collection orders as required by assigned protocols</li><li>Collect specimens as outlined in clinical research protocols</li></ul> 
Professional Development and Compliance 
 
<ul><li>Attend departmental research meetings, conferences, and required training sessions</li><li>Maintain professional expertise through ongoing education and use of reference materials</li><li>Arrange appropriate coverage for assigned responsibilities during time off</li><li>Adhere to institutional and departmental policies and procedures related to clinical trial conduct and compliance</li></ul> 
Other Duties 
 
<ul><li>Perform additional duties as assigned to support departmental and research goals</li></ul> 
OTHER REQUIREMENTS 
 
<ul><li>Required: Ability to practice independently with strong verbal and written communication skills, organizational and critical judgment skills, strong attention to detail, strong organizational skills, ability to use personal computers and standard software, ability to master new software, ability to maintain a satisfactory work environment including physical activity up to lifting 15 pounds, ability to be clearly understood verbally and by telephone, and strong command of the English language.</li></ul> 

EDUCATION 
<ul><li>
Required: High School Diploma or Equivalent</li><li>
Preferred: Bachelor's Degree</li></ul> 

WORK EXPERIENCE 
<ul><li>
Required: 2 years Related experience or</li><li>
Required: No experience required with preferred degree.</li></ul> 
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. 
 
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. 
 
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 
 
Additional Information
 
<ul><li>Requisition ID: 181186
</li><li>Employment Status: Full-Time
</li><li>Employee Status: Regular
</li><li>Work Week: Days
</li><li>Minimum Salary: US Dollar (USD) 44,000
</li><li>Midpoint Salary: US Dollar (USD) 55,000
</li><li>Maximum Salary : US Dollar (USD) 66,000
</li><li>FLSA: non-exempt and 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?: No
</li><li>Relocation Assistance Available?: No
</li></ul> 
#LI-Hybrid</div>

Research Data Coordinator / Interventional Radiology Research

Houston Methodist

<div>At Houston Methodist, the Research Coordinator II position is responsible for coordinating the day-to-day activities of research protocols as well as assessing and determining qualification of patients for research studies. Under minimal supervision, this position is responsible for ensuring accurate data collection, documentation, organization and safety of research participants, gathering patient data for clinical research activities via methods specified in the study protocol and performs general administrative duties supporting the study.
<div>FLSA STATUS 
Exempt 
 
QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree
</li></ul> 
EXPERIENCE<ul><li>
Four years of research experience
</li></ul> 
LICENSES AND CERTIFICATIONS 
Required<ul><li>
</li></ul>Preferred<ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) or</li><li>
CCRP - Certified Clinical Research Professional (SOCRA)
</li></ul> 
SKILLS AND ABILITIES<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 
<li>
</li></ul> 
 
ESSENTIAL FUNCTIONS 
 
PEOPLE ESSENTIAL FUNCTIONS<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> 
SERVICE ESSENTIAL FUNCTIONS<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> 
QUALITY/SAFETY ESSENTIAL FUNCTIONS<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> 
FINANCE ESSENTIAL FUNCTIONS<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> 
GROWTH/INNOVATION ESSENTIAL FUNCTIONS<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. 
<li>
</li></ul> 
 
SUPPLEMENTAL REQUIREMENTS 
<ul>
WORK ATTIRE<li><ul><li>
Uniform: No
</li><li>Scrubs: Yes
</li><li>Business professional: No
</li><li>Other (department approved): Yes
</li></ul></li> 
ON-CALL* 
<li><ul><li>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</li></ul></li><li><ul><li>
On Call* No
</li></ul></li> 
TRAVEL** 
**Travel specifications may vary by department**<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>QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree
</li></ul> 
EXPERIENCE<ul><li>
Four years of research experience
</li></ul> 
LICENSES AND CERTIFICATIONS 
Required<ul><li>
</li></ul>Preferred<ul><li>
CCRC - Certified Clinical Research Coordinator (ACRP) or</li>
CCRP - Certified Clinical Research Professional (SOCRA) 
<li>
</li></ul> 
Company Profile:
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.
Houston Methodist is an Equal Opportunity Employer.</div>

Research Coordinator II - Pulmonary COPD

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader">Summary</h2></div><div>
The Scott Department of Urology at Baylor College of Medicine in Houston, TX is seeking a Research Coordinator II to join the growing Bladder Cancer Research Center team. We are looking for an organized and detail‑oriented laboratory professional who will play a key role in supporting the research program. 
This position assists with the daily operations of the tissue bank and helps maintain a safe, secure environment for all stored specimens. 
Responsibilities include collecting, processing, storing, and transporting human tissue samples across Baylor College of Medicine facilities and affiliated hospitals. 
The Coordinator will also support laboratory research projects within the Bladder Cancer Center, including IHC procedures and the collection of tumor, urine, and blood samples for germline analysis and potential longitudinal follow‑up studies.</div></div><div><div><h2 class="jobSectionHeader">
Job Duties</h2></div><div><ul><li>
Obtain informed consent, screen, and enroll participants in clinical trials.</li><li>
Manage and maintain study visits, source documentation, adverse events (AEs), serious adverse events (SAEs), concomitant medication logs, as well as study subject and regulatory binders.</li><li>
Process, coordinate, and ship biological specimens (e.g., urine and blood) in accordance with protocol requirements.</li><li>
Coordinate clinical studies in compliance with sponsor protocols and timelines.</li><li>
Collaborate effectively with clinical and non-clinical teams to meet sponsor requirements.</li><li>
Collect, review, and analyze study data; perform accurate EDC data entry.</li><li>
Prepare for and support interim monitoring visits (IMVs), audits, and inspections.</li><li>
Ensure ongoing compliance with IRB and regulatory requirements.</li><li>
Partner with the Research Administration Associate on study renewals with central and local IRBs.</li><li>
Generate quarterly reports on enrollment metrics and study milestones.</li><li>
Work closely with the Principal Investigator (PI) to ensure enrollment targets and protocol compliance are achieved.</li><li>
Develop and implement SOPs aligned with clinical workflows for assigned studies.</li><li>
Establish and maintain systems to track, process, and monitor study activities.</li><li>
Perform other related duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Minimum Qualifications</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">
Preferred Qualifications</h2></div><div><ul><li>
Experience with Pilot and Phase III/IV clinical trials.</li><li>
Familiarity with electronic medical records system.</li><li>
Experience with EDC systems (e.g., Medidata Rave).</li><li>
Prior regulatory experience.</li><li>
Strong organizational and time management skills.</li><li>
Ability to work independently and collaboratively in a team environment.</li><li>
Knowledge of urology clinical practices and procedures.</li><li>
Some of these studies involve extensive urine sample collection, patient consenting, and retrieval/printing of source documentation from prior urology records.</li><li>
Requires the ability to work collaboratively with multiple providers and coordinate across their clinics.</li></ul></div></div></div> 
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. 
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</div>

Research Coordinator II - Urology

<div><div><div><div><h2 class="jobSectionHeader">Summary</h2></div><div>
Assist the Research Manager/Director with the implementation, management, and coordination of studies. Coordinates day to day activities of research protocols which include screening, enrollment, and monitoring of research participants. Ensures accurate data collection, documentation, organization and safety of research participants.</div></div><div><div><h2 class="jobSectionHeader">
Job Duties</h2></div><div>
1. Generic Duty: Oversee the recruitment and retention of research participants who are part of the Matsui research program. 
Specific Position Duty: Implement strategies for the recruitment and retention of research participants. Maintain a study database of possible research participants. Interview, screen, and recruit participants for studies, explaining the process and procedures to educate participants regarding study protocols. Act as a contact and resource for study participants. Schedule and confirm study appointments. Submit recruitment/retention reports at weekly meetings. 
2. Generic Duty: Conduct in home or clinic study visits and oversee the collection of data. 
Specific Duty: Conduct study visits, participant interviews, and measurements in participants&rsquo; homes. Collects participants information; processes documents and enters information into a REDCap database. Perform Venipuncture (blood draws), lung function testing, obtain vital signs, collect saliva, nasal swabs/samples, and urine. Collect, process, ship, and maintain paperwork for blood and biological/environmental specimens according to procedures outlined in study protocol. Ensure compliance of QA/QC activities related to studies. 
3. Generic Duty: Maintain IRB regulatory documentation for the Matsui Research Program and ensure that studies are being conducted according to Good Clinical Practice and standard operating procedures. 
Specific Duty: Prepare Institutional Review Board submissions, renewals, and amendments. Prepare data needed for other regulatory related reports and work with the research manager to create these reports. Develop, implement, and maintain standard operating procedures. Maintain manual of procedures for each study assigned and contribute to protocol and procedure recommendations. 
4. Generic Duty: Ensures high quality data collection and maintenance in REDCap. 
Specific Duty: Maintain data entry, organize and maintain REDCap databases and ensure data is complete and accurate. Implement procedures to minimize or eliminate data and sample collection errors to provide high quality data. Use a variety of software and database technologies, including REDCap and Excel. Implements and oversees all updates/changes to the study REDCap database. Record and track the shipping and handling of any study related samples and results. 
5. Generic Duty: Maintain and keep track of all research study related supplies and inventory. 
Specific Duty: Maintain a study inventory and order supplies and equipment. Keeps records of study purchase order and other financial information. Manage and create purchase orders, payment requests, and financial reconciliation in a timely manner. Assist with the review of service agreements and may act as a liaison with internal and outside vendors. Performs other job duties as assigned.</div></div><div><div><h2 class="jobSectionHeader">
Minimum Qualifications</h2></div><div><ul><li>
Bachelor's degree in a Basic Science or related field. Four years of related experience may substitute for degree requirement.</li><li>
Five years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Preferred Qualifications</h2></div><div><ul><li>
Bachelor's Degree in health-related field.</li><li>
Five years of experience working in clinical research.</li><li>
REDCap experience is highly desired for the position.</li></ul></div></div></div> 
Work Authorization Requirement:
This position is not eligible for visa sponsorship. Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment. 
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</div>

Senior Research Coordinator - Pediatrics

<div>At Houston Methodist, the Sr Quality Assurance Analyst position is responsible for working with specified clinical research teams to conduct ongoing quality assurance reviews of clinical research studies, assess site readiness, serve as a resource and site liaison for Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and/or Institutional Biosafety Committee (IBC) regulatory needs, as appropriate, and develop site-specific education and processes to ensure compliance with federal, state laws, and Houston Methodist Research Institute (HMRI) policy and procedure requirements. In addition to performing the duties as a Quality Assurance Analyst, this position serves as a mentor and subject matter expert to study teams and QA team on Good Clinical Practice in Clinical Research, QA practices, HMRI policy and procedures related to clinical research.
<div>FLSA STATUS 
Exempt 
 
QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree in life sciences or related field from an accredited college or university
</li><li>Master&rsquo;s degree in business or life sciences or related field preferred
</li></ul> 
EXPERIENCE<ul><li>
Five years clinical research or equivalent experience in which three years are in Quality Assurance or Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals desirable
</li><li>Training experience in a clinical research setting
</li><li>Regulatory audit exposure with US-FDA preferred
</li></ul> 
LICENSES AND CERTIFICATIONS 
Required<ul><li>
Must have one of the following certifications: CCRP - Certified Clinical Research Professional (SOCRA) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRA - Certified Clinical Research Associate (ACRP) or ACRP-CP - Clinical Research Professional (ACRP)
</li></ul> 
SKILLS AND ABILITIES<ul><li>
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing 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>Excellent working knowledge of FDA regulations and GCP guidelines
</li><li>Excellent working knowledge of the clinical trial operations
</li><li>Ability to identify and/or resolve quality issues/discrepancies with others in a proactive diplomatic, flexible, and constructive manner
</li>Ability to work in a team environment with effective leadership skills 
<li>
</li></ul> 
 
ESSENTIAL FUNCTIONS 
 
PEOPLE ESSENTIAL FUNCTIONS<ul><li>
Facilitates open, professional (verbal, nonverbal, written) communication which includes active listening and teaching, to achieve mutual understanding, role modeling by example. Communication to promote both work efforts and problem resolution is clear, providing the highest quality service during every customer and patient encounter, as it relates to clinical research studies.
</li><li>Provides higher-level support to institutional investigators and other members of the research team, by providing education and training regarding processes and procedures governing clinical research activities which can be ad-hoc, remote/teleconferences, or face-to-face sessions with the entire research team.
</li><li>Serves as a subject matter expert and regulatory resource for department and institution as well as investigators and research staff regarding Institutional Review Board (IRB) and/or Institutional Animal Care and Use committees, current institutional policies, and state and federal laws related to research; provides solutions to study start-up and regulatory management.
</li><li>Teaches, orients and precepts, as appropriate, newly hired analysts. Uses peer-to-peer accountability towards improvement of department score for employee engagement.
</li></ul> 
SERVICE ESSENTIAL FUNCTIONS<ul><li>
Assists in identifying educational needs and creates/implements training courses or materials to assist in compliant research coordination and management.
</li><li>Assists Research Protections staff and HMRI administration, as needed, with pre-clinical and clinical research areas of need, including Research Credentialing, IRB, Institutional Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), Radiation Safety Committee (RSC), and Hazardous Substance Committee (HSC), as appropriate. Provides timely feedback to stakeholders to facilitate swift and efficient process improvement.
</li><li>Evaluates site readiness based on HMRI standards prior to start date of a new clinical trial.
</li></ul> 
QUALITY/SAFETY ESSENTIAL FUNCTIONS<ul><li>
Performs and monitors feasibility assessments, ongoing quality assurance reviews of with pre-clinical and clinical research studies, with the goal of assessing site readiness and develop site-specific education and processes within specified research teams. May assess reviews of lower-level analysts.
</li><li>Monitors and evaluates ongoing quality and compliance standards, along with regulatory and clinical trial trends/actions, with regular reports to QA management. Assists with preparation and/or assists during regulatory inspections.
</li><li>Initiates goals and creates targets for Monitoring Assessment plans (MAPS). Assumes primary responsibility for implementing plan, organizing data, and reporting results to leadership.
</li><li>Utilizes sound judgement, using an analytical approach. Ensures implementation and teaching of department-based initiatives and standards of practice. Identifies trends and opportunities for corrective action and process improvement, providing recommendations.
</li></ul> 
FINANCE ESSENTIAL FUNCTIONS<ul><li>
Initiates cost saving ideas within the department and communicates recommendations to management.
</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> 
GROWTH/INNOVATION ESSENTIAL FUNCTIONS<ul><li>
Independently evaluates responses to monitoring and audit reports; partners with the research team to follow up with respondents, management, or others, if needed, to ensure resolution.
</li><li>Identifies and presents areas for innovation, efficiency, and improvement for department projects. Participates in one or more department committees or subcommittees and facilitates the accomplishment of the goals of the committee or subcommittee.
</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 ongoing basis. 
<li>
</li></ul> 
 
SUPPLEMENTAL REQUIREMENTS 
<ul>
WORK ATTIRE<li><ul><li>
Uniform: No
</li><li>Scrubs: No
</li><li>Business professional: Yes
</li><li>Other (department approved): Yes
</li></ul></li> 
ON-CALL* 
<li><ul><li>Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.</li></ul></li><li><ul><li>
On Call* No
</li></ul></li> 
TRAVEL** 
**Travel specifications may vary by department**<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>QUALIFICATIONS 
 
EDUCATION<ul><li>
Bachelor&rsquo;s degree in life sciences or related field from an accredited college or university
</li><li>Master&rsquo;s degree in business or life sciences or related field preferred
</li></ul> 
EXPERIENCE<ul><li>
Five years clinical research or equivalent experience in which three years are in Quality Assurance or Regulatory Compliance experience within an FDA regulated industry, preferably devices, diagnostics, or pharmaceuticals desirable
</li><li>Training experience in a clinical research setting
</li><li>Regulatory audit exposure with US-FDA preferred
</li></ul> 
LICENSES AND CERTIFICATIONS 
Required
Must have one of the following certifications: CCRP - Certified Clinical Research Professional (SOCRA) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRA - Certified Clinical Research Associate (ACRP) or ACRP-CP - Clinical Research Professional (ACRP) 
<ul><li>
</li></ul> 
Company Profile:
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.
Houston Methodist is an Equal Opportunity Employer.</div>

Senior Quality Assurance Analyst

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