Clinical research coordinator jobs in Denton, TX

Regulatory Associate, Office of Clinical Research - (909774) Description WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY Works under limited supervision to assure compliance with federal regulations relating to human subject research and/or animal care and use. Understands and applies ethical principles and multiple regulations to complex scientific research projects. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: PPO medical plan, available day one at no cost for full-time employee-only coverage 100% coverage for preventive healthcare-no copay Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave Benefit Wellness programs Tuition Reimbursement Public Service Loan Forgiveness (PSLF) Qualified Employer Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION RequiredEducationBachelor's Degree or equivalent Experience2 years of related experience May consider experience and education in lieu of requirements. JOB DUTIES Review study protocols, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements. Provide working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy. Administer expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB/IACUC, when applicable); regular one-on-one meetings with IRB/IACUC Chairs for final determinations; drafting correspondence to investigators regarding IRB/IACUC determinations. Provide consultation and technical assistance to investigators and study personnel regarding requirements for IRB/IACUC submissions, performance of studies, and documentation of compliance. Serve as an information resource to the campus about human subject protection and/or animal care and use. Participate in development of and/or updates to IRB/IACUC guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities. Perform other duties as assigned. SECURITY AND EEO STATEMENTSecurityThis position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.EEO UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Professional & ExecutiveOrganization: 222005 - OCR-Core Clinical Rsch UnitSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 9, 2025, 3:13:46 AM

Your Job: In this highly technical, fast-paced, and challenging position, you'll collaborate with multidisciplinary team members to provide the very best care for our patients. The Research Coordinator 2 perform coordination of all phases of the research process. The Responsibilities will include attainment of the approval process required, coordination of data collection, management, patient follow-up and tracking. Your Job Requirements: • Bachelor degree or Medical Assistant in appropriate discipline • RN Degree preferred • Medical Assistant Certification, and/or a Certified Clinical Research Coordinator (CCRC) required • LVN or RN license, preferred • 2 or more years of related experience Your Job Responsibilities: • Available to sponsor monitors upon study site visits • Follow patients throughout study • Maintain statistical information • Following all rules and regulations from the FDA, IRB, and other agencies designated by the sponsors. • Initiating and maintenance of IRB regulations (including completion of all required documents for submitting for IRB approval) • Coordinating all phases of assigned clinical trials: Ensuring protocol compliance; • Collecting, interpreting and reporting all clinical data • Maintaining drug inventory • Preparing charts for clinic: Pull charts prior to clinic visit • Organization of data pertinent to clinic visit • Completion of case report forms • Attending regular meetings with physicians and other research staff in order to get updates on the progress of the research studies/patients on treatment • Track lab results and obtains final result for NP or Physicians to review: Makes sure lab results are received in a timely manner • Triaging all phone calls for patients (research related or standard of care) considering treatment, on treatment or being followed after treatment • Assistance with writing protocols • Performing study related procedures (lab processing, etc) • Follow patients throughout study • Developing a working knowledge of disease process under study • Performing rating scales and/or tools under investigation • Communicate clearly and openly • Build relationships to promote a collaborative environment • Be accountable for your performance • Always look for ways to improve the patient experience • Take initiative for your professional growth • Be engaged and eager to build a winning team Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare , Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned: TIME magazine Best Companies for Future Leaders, 2025 Great Place to Work Certified™, 2025 Glassdoor Best Places to Work, 2025 PressGaney HX Pinnacle of Excellence Award, 2024 PressGaney HX Guardian of Excellence Award, 2024 PressGaney HX Health System of the Year, 2024

ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. Manage, train and support clinical site staff. Review, comprehend and communicate study protocols. Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). Assist CRC team as requested to facilitate research and business needs. Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's. Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner. Work closely with CRO/CRA and IRB. Perform administrative tasks such as ordering supplies and equipment for the study. Manage all required study start up documentation, training and timelines on assigned study protocols. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: Associate's degree and/or completion of accredited healthcare certification program, required. Comfortable stepping into a leadership role. 2+ years' experience in clinical research, required. 2+ years' experience working as a Clinical Research Coordinator, preferred. Comprehensive knowledge of FDA, GCP & confidentiality. Exceptional attention to detail and organization. Excellent written and communication skills. A proven ability to multi-task in a rapidly changing environment. WORK LOCATION: Irving, Texas TRAVEL INVOLVED: 60% BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!

Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 2-3 year of clinical experience, Ideally would also have Endocrinology experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our position, with room to grow. Our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!!

Summary: Clinical Research Coordinator 2 is a Part Time or Full Time Non-Exempt Position Education and Experience Requirements: Must be eligible to work in the U.S.; H1b visa holders are ineligible More than 4 years of research experience; or 3+ years of research experience and a Bachelor Degree in a relevant area; or 3+ years of research experience and an LVN; or Greater than 1 year of research experience and a Masters Degree or Ph.D. in a relevant area; or SoCRA or ACRP Certification: Highly desirable and counts as one year of experience Software Requirements: Experience with Microsoft Office and research database products Responsibilities: The position of Coordinator 2 (“CRC2”) works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator 2 is responsible for conducting procedures for one or more research studies. The CRC2 may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. A Coordinator 2 will consistently exhibit behavior and communication skills that demonstrate DVARC's commitment to superior customer service and dedication to the care of our veterans. Supervisors: VANTHCS Principal Investigator, DVARC director HR and Operations, works closely with Team Leader Duties: In addition to the knowledge of the duties of an Assistant Coordinator and a Research Coordinator 1, a CRC2 may have the following duties: Assists in the design of research survey forms to capture required participant information Interviews study participants and/or family members to gather research information Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits May perform consent process with patients, ensuring inclusion and exclusion criteria are met, taking responsibility for all aspects of research completeness, enrollment notes, administrative duties and data entry Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data Coordinates, with the assistance of higher grade staff, all regulatory requirements such as preparing safety reports, adverse event paperwork, FDA compliance, sponsor monitoring and logs, laboratory standards, and maintenance of databases related to regulatory requirements May assist with the study budget and negotiation of participant payments Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC Prepares statistical reports, charts and graphs as required Assists in preparation of annual reports for federal, state, and local agencies Informs IRB of amendments to research studies Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies. Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study May provide full supervision to personnel of lower grades May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator Must be able to do a study start up with the appropriate IRB and R&DC and safety committee.

Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager. Duties and Responsibilities: Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment Create and complete study related documents and new study preparation Function as a liaison with pharmaceutical sponsors and external vendors Prepare for study monitor visits (onsite or remote), audit inspections, etc. Respond to internal and external requests for information in a timely manner Perform subject screening and recruitment Contribute to data management for research projects Identify opportunities to improve patient care and satisfaction Conduct patient-facing encounters with compassion, empathy, and thoroughness Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose Obtains and documents adverse event data on appropriate forms Ensure source documents are transcribed to EDC platform per protocol on a timely manner Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate Administration: Ensure that electronic case report forms are completed Create memos, emails, and letters related to study activities Create and maintain reports and/or spreadsheets as requested Ensure that all patient data is entered into the clinical trial management system in a timely manner Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections Responsible for reporting safety information to all regulatory agencies Understand the aspects of Regulatory and IRB requirements for studies Performs quality checks on source documents specific to the study Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Education / Experience: Highschool diploma or general education degree (GED) required Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS Must have strong knowledge of ICH/GCP guidelines Must complete CITI training before interacting with participants and must re-certify every 3 years Must be trained and certified in administration of Fibroscan, training provided during onboarding Must have basic life support (BLS) training, provided during onboarding Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time Strong written and oral communication skills Knowledge of basic medical terminology Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission Comply with the company policies, code of ethics, and guiding values always Proficient in Spanish and English preferred Certificates and Licenses: Valid driver's license and insurance Knowledge, Skills, and Other Abilities: Must be able to effectively communicate with all levels of internal and external contacts Ability to work independently and multi-task in a fast-paced team environment Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients Must be able to work independently and collaborate with a team Ability to interpret clinical research protocols Strong problem-solving and decision-making skills, particularly when under pressure Proactive at identifying, addressing, and solving issues in real time Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids and/or bloodborne pathogens. Personal protective equipment required such as protective eyewear, garments, and gloves. Occasional travel may be required domestic and/or international. Ability to work in an upright and/or stationary position for 6-10 hours per day. Frequent mobility required. Occasionally squatting, kneeling, or bending. Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs. Benefits of working at Pinnacle Clinical Research: 401k Medical, dental, vision, long term disability, short term disability, FSA, and life insurance 3 weeks of paid time off 14 paid company holidays Scrub uniform voucher (specific positions apply) And more! Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.

Oversee and manage clinical research studies from inception to conclusion Collect, document, and maintain study data in compliance with protocol requirements Conduct patient monitoring, including assessments of vital signs Supervise and train research personnel on study protocols and procedures Ensure compliance with FDA regulations and guidelines throughout the research process Review and maintain documentation about the research studies Collaborate with healthcare professionals to support patient care within the study's scope Assist in the collection, analysis, and interpretation of data for research projects Requirements Bachelor's degree in a relevant field (e.g., healthcare, life sciences) or International Medical Graduate Previous experience in clinical research or a related field Knowledge of medical terminology and clinical trial processes Familiarity with data management practices and electronic data capture systems Strong organizational skills with a high attention to detail Ability to work independently and collaboratively within a multidisciplinary team Excellent communication and interpersonal skills for effective collaboration Understanding of ethical considerations in clinical research

We are seeking a skilled and dedicated full-time clinical research coordinator to join our research team at Prime Clinical Research. The ideal candidate should have a strong background as a clinical research coordinator with expertise and certification in phlebotomy. The clinical research coordinator will play a crucial role in providing exceptional patient care, performing phlebotomy tasks, and contributing to the smooth execution of research. This position offers an opportunity to make a meaningful impact on patients' lives and contribute to advancements in medical research. Please note the listed pay is negotiable based on experience. Why us? A great team of clinical and non-clinical staff to work with Get mentored directly/mentored by an amazing Investigators and team. What doing a great job will look like Seeing an average of 6 - 10 patient's visit per 8.5hr day. Maintaining turnaround times of an hour or less 80% of the time (from patient in door time to patient out the door). Building a full patient panel consistently. Being a good team player Aligning with culture of the organization and following leadership of the Supervisor Having a great attitude that is friendly and welcoming to Team members and patients We will help you do a great job through these trainings through the Prime Clinical Research Incs Onboarding process. How to see 6-10 patients' visit per day and leave with no source documentation and EDC tasks incomplete. How to build your clinical research career through networking and coaching. How to have work-life balance How to get 5-star patient ratings and increase patient satisfaction How to multi-task and efficiently use the different systems in clinical research How to manage patient's schedule daily and efficiently. This opportunity is perfect for the Study coordinator who: Has a strong work ethic. Is willing to learn the new skills required to thrive and a quick learner. Is a team player Is flexible Is eager to teachable, correctable, coachable Key Responsibilities: 1. Phlebotomy Expertise: Perform venipuncture and capillary blood collection procedures with precision and care. Ensure patient comfort and safety during blood draws while maintaining sterile techniques. 2. Patient Care: Greet and prepare patients for medical procedures, collect relevant medical history, and explain procedures clearly. Assist healthcare professionals in patient examinations, treatments, and minor procedures. 3. Clinical Trials Support: Assist in the execution of clinical trials. Follow protocols, document procedures accurately, maintain compliance with regulatory requirements, and update CTMS. Collaborate with research staff to ensure smooth trial operations. 4. Sample Handling: Properly label, process, and transport collected blood and other samples. Ensure accurate documentation and timely delivery of samples to the appropriate laboratory or testing facility. 6. Administrative Tasks: Schedule appointments, manage patient records, and update electronic health records accurately and efficiently. Assist with billing and insurance processes as needed. 7. Patient Education: Provide patients with clear instructions for at-home care, medication administration, and follow-up appointments. Address patient questions and concerns with empathy and professionalism. 8. Infection Control: Adhere to strict infection control protocols to minimize the risk of cross-contamination and maintain a safe healthcare environment. 9. Patient Recruitment: Assist in outreach to patients about clinical trials they may be qualified to participate in. Qualifications: - 3-5 years Clinical trial experience is required. - High school diploma or equivalent. - Strongly prefer bilingual Spanish and English-speaking candidates. -Current Good Clinical Practice certification. - Certified Phlebotomy Technician (CPT) certification is required. - Previous experience as a clinical research coordinator, with demonstrated proficiency in phlebotomy techniques in adults and children. -IATA/DOT Dangerous Goods training preferred but not required. - Clear understanding of medical terminology and procedures. - Excellent communication skills, both verbal and written. - Strong interpersonal skills and the ability to work effectively within a multidisciplinary healthcare team. - Attention to detail and strong organizational skills. - Proficiency in using electronic health records (EHR) systems and basic office software. Job Type: Full-time Schedule: Monday to Friday Weekends as needed Work Location: In person

Who We Are JPS Health Network is a $950 million, tax-supported healthcare system in North Texas. Licensed for 582 beds, the network features over 25 locations across Tarrant County, with John Peter Smith Hospital a Level I Trauma Center, Tarrant County's only psychiatric emergency center, and the largest hospital-based family medical residency program in the nation. The health network employs more than 7,200 people. Acclaim Multispecialty Group is the medical practice group featuring over 300 providers serving JPS Health Network. Specialties range from primary care to general surgery and trauma. The Acclaim Multispecialty Group formed around a common set of incentives and expectations supporting the operational, financial, and clinical performance outcomes of the network. Our goal is to provide high quality, compassionate clinical care for every patient, every time. Why JPS? We're more than a hospital. We're 7,200 of the most dedicated people you could ever meet. Our goal is to make sure the people of our community get the care they need and deserve. As community stewards, we abide by three Rules of the Road: 1. Own it. Everyone who wears the JPS badge contributes to our journey to excellence. 2. Seek joy. Every day, every shift, we celebrate our patients, smile, and emphasize positivity. 3. Don't be a jerk. Everyone is treated with courtesy and respect. Smiling, laughter, compassion - key components of our everyday experience at JPS. When working here, you're surrounded by passion, diversity, and dedication. We look forward to meeting you! For more information, visit ********************* To view all job vacancies, visit ********************* ***************************** or ******************** Job Title: Clinical Research Coordinator Requisition Number: 42785 Employment Type: Full Time Division: EDUCATION & LIBRARY Compensation Type: Salaried Job Category: Nursing / LVN Hours Worked: 8am-5pm Location: John Peter Smith Hospital Shift Worked: Day Job Description: Description: The Clinical Research Coordinator is responsible for assisting investigators with the conduct of new or ongoing intervention studies supported by the JPS Health Network Research Institute. This position is involved in intervention studies pertaining to injuries, chronic diseases, and infectious diseases. Typical Duties: * Assists with the development of research protocols, recruitment strategies, budgets, and data collection forms in collaboration with research team. * Prepares regulatory reports and Institutional Review Board submissions and ensures compliance and preparedness for internal and external audits and study monitoring visits. * Coordinates and manages intervention studies, including but not limited to participant recruitment and enrollment, data collection, development and use of case report forms, adverse events reporting, filing and archiving of study records, resolution of data queries, and communication with sponsors and regulatory authorities. * Ensures participant safety and confidentiality throughout all phases of research. * Trains staff and volunteers on the implementation of research protocols. * Maintains databases and ensures timely and accurate documentation of study-related information. * Assists with writing internal reports, as necessary. * Rotates on a weekly on-call schedule to meet study needs. * Attends investigator meetings that may require out-of-state travel, as needed. * Performs other related duties as assigned. Qualifications: Required Education and Experience: * Bachelor's degree in a health-related field from an accredited college or university. * 2 plus years of clinical research experience or 4 plus years of clinical nursing experience. Required Licensure/Certification/Specialized Training: * Completion of human subjects protection training within 30 days of hire. * If applicable, individuals with a professional license (e.g. nurses) must maintain current licensure. Preferred Education and Experience: * Master's degree in a health-related field from an accredited college or university. * 2 plus years of experience in regulatory compliance and conduct of clinical trials. Preferred Licensure/Certification/Specialized Training: * Certified Clinical Research Professional through the Association of Clinical Research Professionals or the Society of Clinical Research Associates. Location Address: 1500 S. Main Street Fort Worth, Texas, 76104 United States

Your Job: In this highly technical, fast-paced, and challenging position, you'll collaborate with multidisciplinary team members to provide the very best care for our patients. The Research Coordinator 2 perform coordination of all phases of the research process. The Responsibilities will include attainment of the approval process required, coordination of data collection, management, patient follow-up and tracking. Your Job Requirements: • Bachelor degree or Medical Assistant in appropriate discipline • RN Degree preferred • Medical Assistant Certification, and/or a Certified Clinical Research Coordinator (CCRC) required • LVN or RN license, preferred • 2 or more years of related experience Your Job Responsibilities: • Available to sponsor monitors upon study site visits • Follow patients throughout study • Maintain statistical information • Following all rules and regulations from the FDA, IRB, and other agencies designated by the sponsors. • Initiating and maintenance of IRB regulations (including completion of all required documents for submitting for IRB approval) • Coordinating all phases of assigned clinical trials: Ensuring protocol compliance; • Collecting, interpreting and reporting all clinical data • Maintaining drug inventory • Preparing charts for clinic: Pull charts prior to clinic visit • Organization of data pertinent to clinic visit • Completion of case report forms • Attending regular meetings with physicians and other research staff in order to get updates on the progress of the research studies/patients on treatment • Track lab results and obtains final result for NP or Physicians to review: Makes sure lab results are received in a timely manner • Triaging all phone calls for patients (research related or standard of care) considering treatment, on treatment or being followed after treatment • Assistance with writing protocols • Performing study related procedures (lab processing, etc) • Follow patients throughout study • Developing a working knowledge of disease process under study • Performing rating scales and/or tools under investigation • Communicate clearly and openly • Build relationships to promote a collaborative environment • Be accountable for your performance • Always look for ways to improve the patient experience • Take initiative for your professional growth • Be engaged and eager to build a winning team Methodist Health System is a faith-based organization with a mission to improve and save lives through compassionate, quality healthcare. For nearly a century, Dallas-based Methodist Health System has been a trusted choice for health and wellness. Named one of the fastest-growing health systems in America by Modern Healthcare, Methodist has a network of 12 hospitals (through ownership and affiliation) with nationally recognized medical services, such as a Level I Trauma Center, multi-organ transplantation, Level III Neonatal Intensive Care, neurosurgery, robotic surgical programs, oncology, gastroenterology, and orthopedics, among others. Methodist has more than two dozen clinics located throughout the region, renowned teaching programs, innovative research, and a strong commitment to the community. Our reputation as an award-winning employer shows in the distinctions we've earned: * TIME magazine Best Companies for Future Leaders, 2025 * Great Place to Work Certified, 2025 * Glassdoor Best Places to Work, 2025 * PressGaney HX Pinnacle of Excellence Award, 2024 * PressGaney HX Guardian of Excellence Award, 2024 * PressGaney HX Health System of the Year, 2024

ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. Manage, train and support clinical site staff. Review, comprehend and communicate study protocols. Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). Assist CRC team as requested to facilitate research and business needs. Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's. Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner. Work closely with CRO/CRA and IRB. Perform administrative tasks such as ordering supplies and equipment for the study. Manage all required study start up documentation, training and timelines on assigned study protocols. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: Associate's degree and/or completion of accredited healthcare certification program, required. Comfortable stepping into a leadership role. 4+ years' experience in clinical research, required. 4+ years' experience working as a Clinical Research Coordinator, preferred. Comprehensive knowledge of FDA, GCP & confidentiality. Exceptional attention to detail and organization. Excellent written and communication skills. A proven ability to multi-task in a rapidly changing environment. WORK LOCATION: Irving, Texas TRAVEL INVOLVED: 60% BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!

Job Description Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 2-3 year of clinical experience, Ideally would also have Endocrinology experience. Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our position, with room to grow. Our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!! Powered by JazzHR zz CIf1OJEi

Clinical Research Coordinator I, Office Clinical Research - (909772) Description WHY UT SOUTHWESTERN? With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U.S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARY Works under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies. BENEFITS UT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include: PPO medical plan, available day one at no cost for full-time employee-only coverage 100% coverage for preventive healthcare-no copay Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave Benefit Wellness programs Tuition Reimbursement Public Service Loan Forgiveness (PSLF) Qualified Employer Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION RequiredEducationBachelor's Degree or higher degree in medical or science related field Experience1 year of clinical research experience May consider additional years of experience or advanced degree in lieu of education or experience, respectively. PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements. ACRP or SOCRA certification a plus JOB DUTIES Directly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person. Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI. When outside of protocol, presents evidence and provides options (within scope of protocol) to PI. Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools Assist in developing and implementing research studies to include writing clinical research protocols. Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars). May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department. Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Review research study protocols to ensure feasibility Assist in developing website or other social media for marketing/recruiting of clinical research study Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems Maintain subject level documentation Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. SECURITY AND EEO STATEMENTSecurityThis position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information.EEO UT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Research & LaboratoryOrganization: 222005 - OCR-Core Clinical Rsch UnitSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 5, 2025, 7:49:07 PM

Job Description Summary: Clinical Research Coordinator 2 is a Part Time or Full Time Non-Exempt Position Education and Experience Requirements: Must be eligible to work in the U.S.; H1b visa holders are ineligible More than 4 years of research experience; or 3+ years of research experience and a Bachelor Degree in a relevant area; or 3+ years of research experience and an LVN; or Greater than 1 year of research experience and a Masters Degree or Ph.D. in a relevant area; or SoCRA or ACRP Certification: Highly desirable and counts as one year of experience Software Requirements: Experience with Microsoft Office and research database products Responsibilities: The position of Coordinator 2 (“CRC2”) works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator 2 is responsible for conducting procedures for one or more research studies. The CRC2 may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. A Coordinator 2 will consistently exhibit behavior and communication skills that demonstrate DVARC's commitment to superior customer service and dedication to the care of our veterans. Supervisors: VANTHCS Principal Investigator, DVARC director HR and Operations, works closely with Team Leader Duties: In addition to the knowledge of the duties of an Assistant Coordinator and a Research Coordinator 1, a CRC2 may have the following duties: Assists in the design of research survey forms to capture required participant information Interviews study participants and/or family members to gather research information Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits May perform consent process with patients, ensuring inclusion and exclusion criteria are met, taking responsibility for all aspects of research completeness, enrollment notes, administrative duties and data entry Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data Coordinates, with the assistance of higher grade staff, all regulatory requirements such as preparing safety reports, adverse event paperwork, FDA compliance, sponsor monitoring and logs, laboratory standards, and maintenance of databases related to regulatory requirements May assist with the study budget and negotiation of participant payments Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC Prepares statistical reports, charts and graphs as required Assists in preparation of annual reports for federal, state, and local agencies Informs IRB of amendments to research studies Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies. Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study May provide full supervision to personnel of lower grades May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator Must be able to do a study start up with the appropriate IRB and R&DC and safety committee.

Position Overview: Prime Clinical Research seeks a full-time Clinical Research Coordinator with strong regulatory specialist experience. The ideal candidate has hands-on CRC skills plus proven IRB/IEC submission experience, mastery of essential documents, and audit-ready eReg/TMF practices. This role supports compliant study start-up, maintenance, and close-out while coordinating patient visits. Pay is negotiable based on experience. Why us? Collaborative team of clinical and non-clinical staff Direct mentorship from experienced Investigators and leadership What doing a great job will look like On-time IRB submissions and approvals for 95% of initial, amendment, and continuing review packages Zero overdue safety reports and protocol deviation submissions eReg/TMF and regulatory binder 100% inspection-ready at all times Consent version control accuracy at 100% with timely re-consents Query turnaround 2 business days for sponsor/CRO requests Reliable support of 610 patient visits per 8.5-hour day without documentation backlog We will help you do a great job through Prime Clinical Research Inc.s onboarding eReg/eTMF fundamentals and version control IRB/IEC submissions, amendments, and continuing review best practices Safety reporting workflows (SAE/SUSAR notifications and timelines) Source, EDC, and CTMS efficiency to end each day with tasks complete Time management for deadlines and work-life balance Communication with sponsors, CROs, and sites This opportunity is perfect for the study coordinator who Has a strong work ethic and meets deadlines Learns quickly and applies feedback Works well on cross-functional teams Is organized, proactive, and accountable Key Responsibilities 1. Regulatory Submissions: Prepare and submit initial IRB packages, amendments, safety letters, annual/continuing reviews, and study closures; maintain submission trackers. 2. Informed Consent Management: Control versions, prepare ICFs, train staff on updates, verify correct consent at each visit, and oversee timely re-consent. 3. Essential Documents & eReg/TMF: Build and maintain investigator site files and eReg/eTMF; collect and track 1572s, FDFs, CVs/licenses, training logs, lab certs, delegation logs. 4. Safety Reporting: Triage and submit SAEs, SUSARs, and significant deviations per timelines; document follow-up and correspondence. 5. Compliance & QA: Ensure GCP, ICH, FDA, and site SOP adherence; conduct internal QC, prep for monitoring visits, audits, and inspections; resolve findings promptly. 6. Start-Up to Close-Out: Support Feasibility, SIV readiness, site activation, recruitment materials approvals, and study close-out documentation. 7. Visit Coordination Support: Schedule visits, verify eligibility documentation, assist source creation, and ensure same-day EDC entry and reconciliation. 8. Communication: Serve as regulatory point of contact for sponsor/CRO/IRB; maintain clear, timely correspondence and meeting notes. 9. Recruitment Support: Coordinate IRB-approved outreach materials and logs in compliance with privacy and protocol. 10. Administrative Tasks: Maintain calendars, trackers, and CTMS; file emails and letters in eTMF/eReg; assist billing/grant compliance documentation as needed. Qualifications 35 years clinical trial experience required, with 13 years in site regulatory submissions and maintenance High school diploma or equivalent required; Associate or Bachelors preferred Current Good Clinical Practice (GCP) certification required ACRP-CP or SoCRA CCRP preferred; CIP a plus Bilingual Spanish/English strongly preferred Proficiency with eReg/eTMF, IRB portals, CTMS, EDC, and standard office software Strong knowledge of ICH-GCP, FDA regulations, and site SOPs Excellent written and verbal communication; strong organization and attention to detail Ability to manage multiple deadlines and support patient visit flow Job Type: Full-time Schedule: Monday to Friday Weekends as needed for regulatory deadlines or visits Work Location: In person

Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. Manage, train and support clinical site staff. Review, comprehend and communicate study protocols. Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). Assist CRC team as requested to facilitate research and business needs. Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's. Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner. Work closely with CRO/CRA and IRB. Perform administrative tasks such as ordering supplies and equipment for the study. Manage all required study start up documentation, training and timelines on assigned study protocols. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: Associate's degree and/or completion of accredited healthcare certification program, required. Comfortable stepping into a leadership role. 2+ years' experience in clinical research, required. 2+ years' experience working as a Clinical Research Coordinator, preferred. Comprehensive knowledge of FDA, GCP & confidentiality. Exceptional attention to detail and organization. Excellent written and communication skills. A proven ability to multi-task in a rapidly changing environment. WORK LOCATION: Irving, Texas TRAVEL INVOLVED: 60% BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!

Job Description Unique opportunity to make an Impact in the healthcare industry… Revival Research Institute, LLC was established in 2015, and headquartered in the Metro Detroit Region, and has been growing ever since. Revival now has a national presence in the Metro-Detroit Region, Texas, Illinois, and Arizona. We have been nationally acknowledged for our diligence to provide the highest quality of data for our clinical research trials. As Revival Research Institute is growing, we are looking to add more qualified professionals to our team, who are looking for an opportunity to grow and learn with us. We are seeking a full-time Clinical Research Coordinator with a minimum of 2 year of clinical experience, for our Woman's Health site. Someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow. However, this interest and background is not necessary, as our ideal candidate is an individual who is detail orientated, being able to maintain organized records, as well as someone who is motivated to learn new things, as our company is always growing and expanding into new therapeutic areas. We are looking for individuals that want the opportunity to learn and grow with us. Clinical Research Coordinators here at Revival Research Institute, should be genuinely respectful of diverse points-of-view and strive for an environment in which inclusiveness drives productivity and results. Clinical Research Coordinators are responsible to coordinate and manage multiple studies. They are also responsible for assisting the Investigators along with other clinical staff, with any study related tasks as follows but not limited to: Participates in research participant screening, recruitment and enrollment. Consent and conduct research visits for data collection/no risk trials or no study article/minimal risk trials with oversight. Responsible for collecting, processing and shipping of research specimens, where applicable. Documents study related information in case report forms or electronic data capture systems, handles data queries and participates in monitoring visits. Obtain, review and maintain source documents. Maintains organization of all trial related documents and correspondence. Implement quality control and assurance methods. Communicate with study sponsors, research team and the Institutional Review Board. Assist with basic regulatory document preparation, with oversight e.g. study amendments, adverse event reporting, protocol deviation reporting. Maintain professional and technical knowledge about Clinical trials. Research participant/family communication, protect patient confidentiality. Preferred Qualifications: Education/ Training: Bachelor's degree in health-related field with one to two years relevant clinical experience OR Master's degree in medical related field with no research experience. Individuals with more experience are preferred, if qualifications exceed entry level, higher positions available. Phlebotomy skills preferred. Certifications, Licensures, and Registrations: National Certification (CRA or ACRP), BLS Certification. Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Maintain data integrity within the department. Must be able to work in a team consisting of physicians, nurses, technicians, secretarial staff and ancillary hospital staff. Knowledge of FDA Regulations and Good Clinical Practices. IMPROVE THE FUTURE AS OUR CLINICAL RESEARCH COORDINATOR!!! Powered by JazzHR 2Ts8dD7hw6

Clinical Research Coordinator I, Simmons Cancer Center - (910757) Description Clinical Research Coordinator I - Simmons Cancer Center WHY UT SOUTHWESTERN?With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U. S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARYWorks under the direction of an Investigator(s) with general supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies. BENEFITSUT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:PPO medical plan, available day one at no cost for full-time employee-only coverage100% coverage for preventive healthcare-no copay Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave BenefitWellness programs Tuition ReimbursementPublic Service Loan Forgiveness (PSLF) Qualified EmployerLearn more about these and other UTSW employee benefits!EXPERIENCE AND EDUCATIONRequiredEducationBachelor's Degree or higher degree in medical or science related field Experience1 year of clinical research experience May consider additional years of experience or advanced degree in lieu of education or experience, respectively. PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements. ACRP or SOCRA certification a plus ExperiencePrevious Lab based research experience is highly preferred JOB DUTIESDirectly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person. Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI. When outside of protocol, presents evidence and provides options (within scope of protocol) to PI. Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools Assist in developing and implementing research studies to include writing clinical research protocols. Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars). May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department. Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Review research study protocols to ensure feasibility Assist in developing website or other social media for marketing/recruiting of clinical research study Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems Maintain subject level documentation Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. SECURITY AND EEO STATEMENTSecurityThis position is security-sensitive and subject to Texas Education Code 51. 215, which authorizes UT Southwestern to obtain criminal history record information. EEOUT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Research & LaboratoryOrganization: 371015 - SCC-Core BiomarkersSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 4, 2025, 12:29:22 AM

Job Description ESSENTIAL DUTIES AND RESPONSIBILITIES: Partner with Regional Site Director to ensure compliance and productivity of all clinical site staff and operations. Manage, train and support clinical site staff. Review, comprehend and communicate study protocols. Oversee Site Initiation Visit (SIV), Pre-Study Validation Visit (PSV) and Interim Monitoring Visit (IMV). Assist CRC team as requested to facilitate research and business needs. Conduct and manage clinical trials in accordance with the study protocol guidelines and internal SOP's. Ensure all data is entered into sponsor's data portal and all queries are resolved in a timely manner. Work closely with CRO/CRA and IRB. Perform administrative tasks such as ordering supplies and equipment for the study. Manage all required study start up documentation, training and timelines on assigned study protocols. QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. EDUCATION AND EXPREIENCE: Associate's degree and/or completion of accredited healthcare certification program, required. Comfortable stepping into a leadership role. 4+ years' experience in clinical research, required. 4+ years' experience working as a Clinical Research Coordinator, preferred. Comprehensive knowledge of FDA, GCP & confidentiality. Exceptional attention to detail and organization. Excellent written and communication skills. A proven ability to multi-task in a rapidly changing environment. WORK LOCATION: Irving, Texas TRAVEL INVOLVED: 60% BENEFITS: 401 (k) Retirement Plan Medical, Dental, and Vision Insurance Paid Time Off (PTO) Floating Holidays And more!