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clinical research coordinator

Community Clinical Trials

<div>
 <p>
  <strong>
   POSITION: CLINICAL RESEARCH COORDINATOR
  </strong>
  &nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  <strong>
   &nbsp;Responsibilities
  </strong>
  &nbsp;
 </p>
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  &nbsp;
 </p>
 <p>
  1. Study Coordination&nbsp;
 </p>
 <p>
  &nbsp;- Work closely with principal investigators to plan and execute clinical research studies.&nbsp;
 </p>
 <p>
  &nbsp;- Ensure compliance with study protocols, regulatory guidelines, and ethical standards.&nbsp;
 </p>
 <p>
  &nbsp;- Coordinate study activities, including participant recruitment, enrollment, and retention.&nbsp;
 </p>
 <p>
  &nbsp;- Schedule participant visits and coordinate study procedures.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  2. Participant Management&nbsp;
 </p>
 <p>
  &nbsp;- Screen and recruit eligible participants according to study criteria.&nbsp;
 </p>
 <p>
  &nbsp;- Obtain informed consent from participants and ensure understanding of study procedures.&nbsp;
 </p>
 <p>
  &nbsp;- Provide support and guidance to participants throughout the study duration.&nbsp;
 </p>
 <p>
  &nbsp;- Coordinate participant follow-up visits and assessments.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  3. Data Management&nbsp;
 </p>
 <p>
  &nbsp;- Collect, record, and maintain accurate and complete study data.&nbsp;
 </p>
 <p>
  &nbsp;- Enter data into study databases or electronic data capture systems.&nbsp;
 </p>
 <p>
  &nbsp;- Ensure data quality and integrity through regular monitoring and verification.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  4. Regulatory Compliance&nbsp;
 </p>
 <p>
  &nbsp;- Assist with preparation and submission of regulatory documents, such as Institutional Review Board (IRB) applications and informed consent forms.&nbsp;
 </p>
 <p>
  &nbsp;- Maintain study documentation and regulatory files in accordance with regulatory requirements.&nbsp;
 </p>
 <p>
  &nbsp;- Monitor and ensure compliance with Good Clinical Practice (GCP) guidelines and applicable regulations.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  5. Communication and Collaboration&nbsp;
 </p>
 <p>
  &nbsp;- Serve as a liaison between study sponsors, investigators, research staff, and participants.&nbsp;
 </p>
 <p>
  &nbsp;- Coordinate communication and meetings with study team members and stakeholders.&nbsp;
 </p>
 <p>
  &nbsp;- Collaborate with interdisciplinary teams to resolve study-related issues and challenges.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  6. Administrative Tasks&nbsp;
 </p>
 <p>
  &nbsp;- Assist with budgeting, financial tracking, and procurement related to study activities.&nbsp;
 </p>
 <p>
  &nbsp;- Prepare and maintain study-related documentation, including study manuals, SOPs, and training materials.&nbsp;
 </p>
 <p>
  &nbsp;- Coordinate study logistics, such as equipment and supplies procurement.&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
  &nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  - Previous experience in oncology clinical research coordination&nbsp;Is a bonus.&nbsp;
 </p>
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  - Knowledge of clinical research regulations, GCP guidelines, and ethical principles.&nbsp;
 </p>
 <p>
  - Strong organizational skills and attention to detail.&nbsp;
 </p>
 <p>
  - Excellent communication and interpersonal skills.&nbsp;
 </p>
 <p>
  - Proficiency in computer applications, including MS Office and electronic data capture systems.&nbsp;
 </p>
 <p>
  - Ability to work independently and as part of a team in a fast-paced environment.&nbsp;
 </p>
 <p>
  - Certification in clinical research (e.g., ACRP, SOCRA) desirable but not required.&nbsp;
 </p>
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  &nbsp;
 </p>
 <p>
  Additional Requirements&nbsp;
 </p>
 <p>
  &nbsp;
 </p>
 <p>
  - Willingness to adhere to strict confidentiality requirements.&nbsp;
 </p>
 <p>
  - Flexibility to work occasional evenings or weekends, depending on study requirements.&nbsp;
 </p>
 <p>
  - Ability to travel to off-site locations for participant visits or study-related meetings, if necessary.&nbsp;
 </p>
</div>


Clinical Research Coordinator

Care Access

<div><div><p><b>About Care Access</b></p>
<p>
Care Access is working to make the future of health better for all. <b>With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. </b>We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, <b>and contribute to the medical breakthroughs of tomorrow.</b></p>
<p>
With programs like <i>Future of Medicine</i>, which makes advanced health screenings and research opportunities accessible to communities worldwide, and <i>Difference Makers</i>, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.</p>
<p>
To learn more about Care Access, visit www.CareAccess.com.</p></div><h3 class="jobSectionHeader"><b>
How This Role Makes a Difference</b></h3>
<div>
<p>The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. The CRC III is responsible for the most pivotal and complex protocols and study designs being conducted at Care Access Research sites.</p>
</div>
<div><h3 class="jobSectionHeader"><b>How You'll Make An Impact</b></h3>
<div><ul><li>Patient Coordination
<ul><li>Manages some of the sites most challenging therapeutic areas and study designs
</li><li>High complexity; intensive assessments, multi‑arm trials, frequent sponsor interaction.</li>
<li>Champions balancing protocol needs with patient experience and safety across studies; models best practices.
</li><li>Can operate as solo CRC onsite</li>
<li>Prescreen study candidates</li>
<li>Obtain informed consent per Care Access SOP</li>
<li>Complete visit procedures in accordance with protocol.</li>
<li>Complete basic clinical procedures per protocol, such as blood draws, vital signs, ECGs, etc.</li>
<li>Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion.</li>
<li>Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff.</li>
<li>Prioritize activities with specific regard to protocol timelines</li>
<li>Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials.</li>
<li>Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives.</li>
<li>Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate)</li>
</ul></li><li>Documentation
<ul><li>Record data legibly and enter in real time on paper or e-source documents</li>
<li>Accurately record study medication inventory, medication dispensation, and patient compliance.</li>
<li>Resolve data management queries and correct source data within sponsor provided timelines</li>
<li>Assist regulatory personnel with completion and filing of regulatory documents.</li>
<li>Assist in the creation and review of source documents.</li>
</ul></li><li>Patient Recruitment
<ul><li>Assist with planning and creation of appropriate recruitment materials.</li>
<li>Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.</li>
<li>Actively work with recruitment team in calling and recruiting subjects</li>
</ul></li><li>Site Support
<ul><li>Primary point of contact for the site</li>
<li>Supports Key Sponsors and CROs</li>
<li>Responsible for mentoring and training CRAs and CRC I/CRC II to ensure complete understanding of Care Access processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities</li>
<li>Supports training and process improvements.</li>
<li>Assist Regional Site Director, Operational Compliance and Quality Assurance Departments with all Care Quality and FDA audits</li>
<li>Develops and maintains CAPAs, when needed, with approvals from the Regional Site Director</li>
<li>Review and assess protocol (including amendments) for clarity, logistical feasibility
</li><li>Sets quality standards; prepares for audits; leads corrective actions.
</li></ul></li><li>Other Responsibilities
<ul><li>Leads complex studies; coaches team; influences site operations.
</li><li>Ensure that all training and study requirements are met prior to trial conduct.</li>
<li>Communicate clearly verbally and in writing.</li>
<li>Attend Investigator meetings as required.</li>
<li>Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords)</li>
<li>Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management.</li>
<li>Maintain effective relationships with study participants and other care Access Research personnel.</li>
<li>Demonstrate deep knowledge about the therapeutic area of responsibility including comprehensive understanding of related Protocol designs, outcomes and timelines</li>
<li>Drives improvements; removes barriers; mentors others through change.
</li></ul></li></ul></div><h3 class="jobSectionHeader"><b>The Expertise Required</b></h3>
<div><ul><li>Bilingual in Spanish required</li>
<li>Ability to understand and follow institutional SOPs.</li>
<li>Excellent working knowledge of medical and research terminology</li>
<li>Excellent working knowledge of federal regulations, good clinical practices (GCP)</li>
<li>Ability to communicate and work effectively with a diverse team of professionals.</li>
<li>Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail</li>
<li>Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel.</li>
<li>Critical thinker and problem solver</li>
<li>Friendly, outgoing personality; maintain a positive attitude under pressure.</li>
<li>High level of self-motivation and energy</li>
<li>Excellent professional writing and communication skills</li>
<li>Ability to work independently in a fast-paced environment with minimal supervision.</li>
<li>Engage in continuous independent learning within the therapeutic area of responsibility</li>
<li>Leads cross‑site communications; represents site with sponsors/CROs.
</li><li>Highly autonomous; leads study execution and resolves operational challenges independent</li>
</ul></div><div><h3 class="jobSectionHeader"><b>Certifications/Licenses, Education, and Experience:</b></h3>
</div><div><ul><li>Bachelor's Degree preferred, or equivalent combination of education, training and experience.</li>
<li>A minimum of 5 years prior Clinical Research Coordinator experience required</li>
<li>Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator
</li><li>Recent phlebotomy experience required
<ul><li>California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health</li>
<li>Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners</li>
<li>Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health</li>
<li>Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health</li>
</ul></li></ul></div><h3 class="jobSectionHeader"><b>How We Work Together</b></h3>
<ul><li><b>Location</b>: This is an on-site position with regional commute requirements. Position requires onsite work 5 days per week at the Houston, TX clinic.</li>
<li><b>Travel</b>: This role requires up to 10% travel requirements further explained below. Length of regional (within 100 miles) travel will depend upon study requirements, staff needs, and company initiatives.
</li><li><b>Physical demands associated with this position Include</b>: The ability to use keyboards and other computer equipment.
<ul><li>Walking, standing, sitting, and driving - 20% each</li>
<li>Lifting up to, over, and overheard 25 lbs - 20%</li>
</ul>
</li></ul><p>The expected salary range for this role is $65,000 - $95,000 USD per year for full time team members.</p>
<h3 class="jobSectionHeader"><b>
Benefits &amp; Perks (US Full Time Employees)</b></h3>
<ul><li>Paid Time Off (PTO) and Company Paid Holidays</li>
<li>100% Employer paid medical, dental, and vision insurance plan options</li>
<li>Health Savings Account and Flexible Spending Accounts</li>
<li>Bi-weekly HSA employer contribution</li>
<li>Company paid Short-Term Disability and Long-Term Disability</li>
<li>401(k) Retirement Plan, with Company Match</li>
</ul>
</div><div><p><b>Diversity &amp; Inclusion</b></p>
<p>
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.</p>
<p>
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.</p>
<p>
Care Access is unable to sponsor work visas at this time.</p>
<p>
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com</p>
<p>
Mandatory Employer Disclosures:<br>
<b>Notice to Illinois applicants:</b> Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.<br>
<b>Notice to Connecticut applicants:</b> Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.<br>
<b>Notice to Arizona, Georgia, Indiana, and North Dakota applicants:</b> Care Access complies with applicable laws prohibiting smoking in and around places of employment.<br>
<b>Notice to Massachusetts applicants:</b> It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.<br>
<b>Notice to Rhode Island applicants: </b>Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29&ndash;38 of Title 28 of the Rhode Island General Laws.<br>
<b>Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.</b></p></div></div>

Clinical Research Coordinator III (Bilingual in Spanish)

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><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>Required</b><ul><li>
</li></ul><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>Required</b><ul><li>
</li></ul><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 - Medicine - Pulmonary COPD

Baylor College of Medicine

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
Baylor College of Medicine Department of Pediatrics, Allergy &amp; Immunology Service at Texas Children's Hospital is seeking a highly motivated, responsible, and organized individual to join the Food Allergy Research Program (FAP) as a Research Coordinator. The ideal candidate can work independently and in a team environment with a strong sense of professionalism and is willing to accommodate occasional irregular working hours.</p><p></p><p><br>
The Research Coordinator II, will be responsible for coordinating and/or assisting with day to day activities of research protocols for the Food Allergy Program. This includes screening, enrollment, assist with questionnaire forms, extracting data from medical records, review protocols, review study materials to ensure compliance with the IRB approved protocols and monitoring of research patients. Ensures accurate data collection, documentation, organization and safety of research participants. Additionally, the Research Coordinator will be responsible for processing, storing, documenting and shipping blood samples collected from patients on research studies. The research coordinator will work closely with the investigators, study team, and regulatory staff to ensure the research studies are performed in accordance with federal regulations, sponsor guidelines, and departmental policies. Strong organizational skills are required to coordinate events such as patient/family engagement activities and organize and conduct team meetings.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Coordinate day to day activities of research protocols which include recruitment, screening, enrollment, monitoring visits, conducting study visit procedures, sample collection, scheduling, administer surveys for research participants.</li><li>
Collects patient information; processes documents and enters information into a database.</li><li>
Perform data entry and answer queries.</li><li>
May collect, process, ship, and maintain paperwork for blood and/or biological specimens according to procedures outlined in study protocol.</li><li>
Maintains records and regulatory documents and records for research studies.</li><li>
Retrieves and submits test results to appropriate party</li><li>
May correspond with patient throughout study.</li><li>
Orders supplies and equipment.</li><li>
Conducts all testing procedures required by study protocol.</li><li>
Evaluates and analyzes clinical research data.</li><li>
Prepares documentation necessary to obtain initial and continued approval for the specific research protocol.</li><li>
Promotes education and awareness for patients and families.</li><li>
Knowledgeable in documenting study information per protocol.</li><li>
Conducts chart review to identify research participants.</li><li>
Attend and present at weekly research meetings with Principal Investigator and team members</li><li>
Maintains and organizes inventory of study supplies.</li><li>
Participates in rotating weekend on-call schedule.</li><li>
Performs other job duties as assigned.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
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>
Strong attention to detail.</li><li>
Experience collecting, processing, and shipping samples.</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>

Research Coordinator II - Pediatrics - Allergy & Immunology

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><div>
The Research Coordinator III (RCIII) for Texas Children's Cancer and Hematology Centers (TXCH) is responsible for independently coordinating and executing the daily activities of clinical research studies. Key responsibilities include participant screening, enrollment, and follow‑up; ensuring accurate and timely data collection and documentation; and maintaining participant safety and regulatory compliance. The RCIII supports studies of varying complexity, ranging from low‑complexity registry projects to moderate‑ and high‑complexity interventional therapeutic trials. This role requires an experienced research professional capable of working with a high degree of independence once trained.</div></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Screens patients for eligibility for both therapeutic and non-therapeutic protocols.</li><li>
Performs the subject consent process for biology/procurement and registry studies.</li><li>
Explains processes and procedures to educate participants regarding research studies.</li><li>
Attends and coordinates patient visits as required by the therapeutic protocol.</li><li>
Processes documents and enters information into databases or case report forms.</li><li>
Reviews monthly statements of protocol-related charges for patients as required.</li><li>
Maintains study subject files, collects, processes, ships, and maintains paperwork for blood and/or biological specimens according to procedures outlined in study protocol and SOPs.</li><li>
Assesses patient data for compliance and serious adverse event reporting.</li><li>
Initiates expeditious reviews of study data and source documentation with the Principal Investigator as warranted.</li><li>
Schedules research participants for tests and procedures such as laboratory tests, x-rays, retrieves and submits test results to appropriate parties.</li><li>
Corresponds with internal and external patients throughout study.</li><li>
Orders supplies and equipment.</li><li>
Performs other job duties as assigned, and other studies specific for the research protocol.</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>
Two years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
Familiarity with the Clinical Research Resources Database.</li><li>
Familiarity with how to pull data from Epic.</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>

Research Coordinator III

<div><div><div><div><h2 class="jobSectionHeader"><b>Summary</b></h2></div><div><p>
The Senior Quality Assurance and Control Associate (Senior QA/QC Associate) will monitor clinical research study activities for the Texas Children's Cancer and Hematology Centers (TXCH) and the BCM Center for Cell and Gene Therapy (CAGT) to ensure compliance with all relevant local, federal, and state regulatory and institutional policies while identifying protocol problems, reviewing study-related documents, and ensuring that appropriate corrections are made and documented for missing or incomplete data. Under the guidance and supervision of the QA/QC Manager, the Senior QA/QC Associate will provide training and quality control (QC) evaluations for TXCH and CAGT clinical research staff. The Senior QA/QC Associate will also review and update existing clinical research Standard Operating Procedures (SOPs) as well as develop new SOPs as needed.</p><p></p><p><br>
Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Job Duties</b></h2></div><div><ul><li>
Monitors protocol compliance and documentation, performs clinical study conduct reviews, and verifies clinical research staff competencies. This includes review of investigator-initiated, group sponsored, industry sponsored, treatment and non-treatment studies administered by TXCH and CAGT.</li><li>
Provides SOP training for TXCH and CAGT clinical research staff.</li><li>
Develops, distributes, and maintains clinical research standard operating procedures based on regulations and implements improvements as necessary.</li><li>
Ensures procedures meet or exceed all relevant institutional, state, and federal requirements for the conduct of clinical research; and ensures clinical research activities are conducted, generated, documented, and reported in compliance with the protocol, Good Clinical Practice (GCP) guidelines, and all other applicable regulatory agencies.</li><li>
Provides support for clinical research operations by assisting in the preparation for audits by entities such as the FDA, industry sponsors, or cooperative groups.</li><li>
Prepares QC review reports for principal investigators (PIs) and clinical research teams to effectively communicate findings, and works with TXCH and CAGT leadership to provide suitable recommendations for corrective actions.</li><li>
Presents QC review reports to the TXCH/CAGT Clinical Research Oversight Committee (CROC) at monthly meetings.</li><li>
Performs other job-related duties as assigned.<br>
</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Minimum Qualifications</b></h2></div><div><ul><li>
Bachelor's degree.</li><li>
Four years of relevant experience.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Preferred Qualifications</b></h2></div><div><ul><li>
B.S. or B.A. in science or health related field</li><li>
CCRA, CCRP, or CCRC</li><li>
Knowledge of clinical research operations, medical terminology, and anatomy</li><li>
Prior oncology clinical research QA/QC experience</li></ul></div></div></div><p></p><p><b><br>
Work Authorization Requirement:</b></p><p><b>
This position is not eligible for visa sponsorship.</b> Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.</p><p></p><p><br>
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.</p></div>

Clinical Research Senior Quality Assurance and Control Associate

Spring Clinical Research

<p><b>Job Description:</b></p><p>We are seeking a motivated and detail-oriented Clinical Research Assistant to join our dynamic research team. The successful candidate will play a pivotal role in supporting clinical trials and research studies aimed at advancing medical knowledge and improving patient care. The Clinical Research Assistant will work closely with the research team, study participants, and healthcare professionals to ensure the smooth and ethical execution of research projects.</p><p><b>Key Responsibilities:</b></p><p><b>Participant Recruitment and Screening:</b>Identify and recruit eligible study participants according to study criteria.<br/>Screen potential participants to ensure their suitability for the research.<br/><b>Data Collection and Documentation:</b>Assist in the collection of clinical data, including medical histories, laboratory results, and vital signs.<br/>Maintain accurate and organized records of all research-related activities.<br/>Ensure data integrity and compliance with study protocols.<br/><b>Informed Consent Process:</b>Explain the research study to participants and obtain informed consent.<br/>Maintain documentation of informed consent processes.</p><p><b>Clinical Procedures: </b>Assist with clinical procedures, including administering medications, medical tests, and assessments as per the study protocol.<br/>Ensure adherence to ethical and safety standards.</p><p><b>Data Management:</b>Enter, manage, and analyze research data using electronic databases and software.<br/>Generate reports and assist in data interpretation.</p><p><b>Regulatory Compliance:</b>Ensure compliance with regulatory requirements, including Good Clinical Practice (GCP) guidelines.<br/>Assist in preparing and submitting regulatory documents as needed.</p><p><b>Study Coordination:</b>Collaborate with principal investigators, physicians, nurses, and other healthcare professionals involved in the research.<br/>Coordinate study-related activities and scheduling.</p><p><b>Participant Follow-up:</b>Maintain regular contact with study participants to track their progress and ensure retention in the study.</p><p><b>Quality Assurance:</b>Assist in monitoring and auditing study sites to ensure protocol adherence and data quality.</p><p><b>Adverse Event Reporting:</b>Promptly report adverse events and safety concerns to the appropriate regulatory bodies.</p><p>Job Type: Full-time</p><p>Pay: $12.00 - $16.00 per year</p><p>Benefits:</p><ul><li>Flexible schedule</li></ul><p>Experience:</p><ul><li>Clinical trials: 1 year (Preferred)</li><li>Research: 1 year (Preferred)</li></ul><p>Work Location: In person</p>

Clinical Research Assistant

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