Clinical research coordinator jobs in Midlothian, TX - 110 jobs

Job Title: Clinical Research Associate (Medical Device) Work Arrangement: 1099 Consulting (Remote with 30-50% Travel) Required Skills: 3-5 years of Medical Device clinical monitoring. Proficiency in FDA regulations (IDE/510k) and ICH guidelines. Experience with full-cycle study conduct (selection through close-out). Preferred Skills: CRA Certification (CCRA via SOCRA or ACRP). Neurology therapeutic experience. Employer Value Proposition: Join a well-funded startup in a high-impact role. Influence product readiness through direct collaboration with R&D and Regulatory Affairs while enjoying the autonomy of a remote, flexible consulting arrangement. Job Description: As a Clinical Research Associate with the company, you are the guardian of data integrity for life-changing medical technology. You aren't just a monitor; you are the eyes and ears of a specialized clinical program. You'll spend your days building vital relationships with investigators, ensuring every data point is bulletproof, and collaborating directly with R&D and Regulatory teams to move innovative neurology devices from the lab to the patients who need them most. Why This Role is Different: Total Project Ownership: Manage the full study lifecycle-from site selection to close-out-within a high-visibility startup environment. Strategic Impact: Influence the company's future by contributing directly to IDE and 510(k) regulatory submissions. True Autonomy: Manage your own travel schedule and remote workspace while overseeing a well-funded clinical program. Your Mission: You will ensure every facet of our studies meets the highest standards of quality. Your focus is on the "big picture" of study success: Site Management: Drive day-to-day execution and conduct visits to ensure protocol adherence and patient safety. Data Integrity: Meticulously review source documentation and CRFs to ensure every data point is audit-ready. Collaboration: Act as the vital link between external investigators and our internal R&D and Regulatory departments. Qualifications: We are looking for a professional with a Bachelor's degree in a scientific field, 3-5 years of medical device monitoring experience , and a deep understanding of FDA/ICH guidelines . If you are a highly organized communicator ready for 30-50% travel, we want to hear from you.

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 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

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.

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

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery. Job Description The Site/Study Coordinator supports a medical institution in clinical trial-related activities. Protocol-specific tasks will be determined by the Principal Investigator, considering all local and federal laws and regulations and upon review of competencies observed and documented by Milestone One. Tasks may include activities associated with the assessment of the feasibility of new/potential clinical studies, conducting research-related visits as outlined in the respective protocol, assisting the site with logistics of scheduling research visits and testing per the schedule of events in the protocol, collaboration with ancillary departments involved in the research visit to assist in a smooth patient flow at research visits., general study conduct tasks, assistance with data entry into study related EDC systems, contact with CRO or sponsor representatives to schedule and conduct monitoring visits as well as resolve study specific issues at the medical institution. In addition, mentoring staff and administrative tasks as assigned by the Milestone One Manager. In this job you will: Acts as a constant line of communication between Milestone One, the Sponsor or CRO, and the medical institution. Facilitates the evaluation of proposed studies and ensures responses to feasibility questions are provided in due time. Actively participates in patient recruitment/identification and evaluation for study inclusion by confirming eligibility according to the Inclusion and exclusion criteria. Assists with plan development for new recruitment / retention tools, source documentation and other site tools to enhance quality and time management of research staff. Assists the local research team in obtaining informed consent before study entry or any study-related procedures or tests being performed. Assist with obtaining the required assessments at each visit per the protocol and notify the investigator of any critical values that need immediate attention or would prohibit or delay study treatment. Assist with obtaining local and central laboratory testing, processing, and shipping per site SOP and study-specific lab manual. Assist in scheduling and preparation for all types of sponsors or CRO representative visits at the medical institution. Track patient recruitment and enrollment and actively supports the medical site team to ensure enrollment targets are met at the site level. Provides regular updates to the staff and investigators regarding study amendments. Ensure accurate and timely data entry into study-specific EDC systems, resolves data queries, and assists in reporting and following up on adverse events and protocol deviations according to guidelines and investigator instructions. Support proper handling, accountability, and reconciliation of all investigational products and clinical supplies. If applicable, always maintain the study blinding. Protocol and sponsor/CRO guidance will be followed if a study participant requires unblinding. Assist site staff with maintaining appropriate temperature monitoring for study products and supplies. Support the contract and budget negotiations and oversees Investigator/Site Payments. Ensure that all staff participating in a clinical trial complete all necessary study-specific and general training before their involvement in the trial. Retraining will be completed for changes to the protocol before site implementation. Be responsible for ensuring the investigator reviews and signs study documents appropriately and within a reasonable period. Guidance should be provided to educate the site research team on requirements for conducting clinical trials, date format, etc. Actively participate in maintaining study documents at the medical institution in preparation for on-site study visits/audits or regulatory agency inspections. Assist with preparing and submitting regulatory documents and correspondence to regulatory authorities and institutional review boards (IRBs). May be involved in the on-site training of additional staff as part of the SEO or other education programs. Assist with identifying areas that need improvement for specific sites and assists with developing tools to assist with improvements. Maintain all licensure and certifications applicable to the role of SEO site/Study coordinator II. SEO SC is responsible for only performing assigned tasks within their training and licensure if applicable. SEO SC should immediately consult the assigned Milestone One manager for tasks that do not fall within their scope. Qualifications Education Relevant education and at least two years of experience coordinating clinical research studies involving human subjects OR, if allowed by local regulations, on-the-job training with at least two years of experience coordinating clinical research studies involving human subjects. Language Requirements Bilingual proficiency in English and Spanish is required. Certifications Current Good Clinical Practice (GCP) International Air Transport Association (IATA) Current Basic Cardiopulmonary Resuscitation (CPR) Phlebotomy certification unless part of active professional licensure (RN or LPN) Preferred Certification in Clinical Research by ACRP or SOCRA or another approved Clinical Research Organization. May be obtained within (1) year of employment or status change if not currently certified. Additional Information Located in Fort Worth, Texas (On-site position). If you feel it is time to make your skills and knowledge visible within a developing company with true focus on its people, then Milestone One is the right choice for you!

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

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Job Title: Clinical Research Coordinator II Location: GIA - Mansfield, TX Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities Administratively and clinically manage industry sponsored clinical trials. Adhere to Research SOP's, Good Clinical Practices, and the study protocols. Assist in patient recruitment by performing detailed chart reviews and patient interviews. Discuss study protocols with patients and verify the informed consent documentation. Review medical history of patients against inclusion/exclusion criteria of studies. Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. Schedule all patient research visits and procedures consistent with protocol requirements. Dispense study medication, collect vital signs, and perform ECGs. Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. Function in a clinical role by conducting clinical research studies. Monitor patients and provide information to the medical staff and other staff members to assure optimal outcomes. Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. Act as a resource for other staff members regarding investigational issues or guidelines. Coordinate the availability and distribution of medications for patients in a timely manner. Perform phlebotomy for lab work as required and completes all necessary forms. Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. Assist the principal investigator, research team, and Regional Director with various administrative tasks associated with the day-to-day operations of research studies and projects. Plan and coordinate with the research team and Regional Director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. Plan, implement, and maintain data collection and analysis systems in support of the research protocol. Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. Facilitate assigned clinical trial from start to finish. Screen participants for all studies independently. Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized General Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. Incorporate a leadership mindset to your role. Comply with Impact Research procedures, policies, and regulations relevant to your role. Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. Computer skills - good working knowledge of MS office. Ability to communicate effectively with others, both verbally and in writing. Proven ability to manage time, meet deadlines and prioritize. Able to maintain standards and professionalism during periods of fluctuating workloads. Provide professional service to direct customers of Impact Research in all interactions. Build effective working relationships with other team members. Manage daily tasks to ensure business needs are consistently met. Provide professional service to direct customers of One GI in all interactions. Build effective working relationships with other team members. Manage daily tasks to ensure business needs are consistently met. Education and Qualifications High School Diploma or equivalent required. Associate or Bachelor's degree preferred. Three+ years previous experience in clinical research for pharmaceutical phase II or III trials required. Previous GI trials experience preferred. Clinical experience in an office or hospital setting. Must maintain current licensure and/or certification. Basic Life Support certification required. Knowledge of medical terminology, anatomy, physiology, and pathophysiology. Familiarity with health care systems, regulations, policies, and functions. Understanding of clinical research documentation standards. Knowledge of equipment, supplies, and materials needed for medical treatment. Understanding of basic laboratory procedures including phlebotomy, preparation, and screening. Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. The Iterative Health Site Network is a premier network of 70+ clinical research sites across US and Europe accelerating the path to market for gastrointestinal (GI) and hepatology novel therapies. Our focus is on driving the success and growth of our partner sites by empowering them with tech-enabled services. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. Job Title: Clinical Research Coordinator II Location: GIA - Mansfield, TX Job Summary: The Clinical Research Coordinator is responsible to coordinate and administer research study associated activities and ensures that regulatory requirements are followed including adherence to the principles of good clinical practices (GCPs) and adequate human subject protection (HSP). Conduct clinical drug trials in a manner which ensures compliance with regulatory standards, sponsor requirements, patient safety and confidentiality and high professional standards. FLSA: Non-Exempt Supervisory Responsibility: This position has no supervisory responsibilities Key Responsibilities * Administratively and clinically manage industry sponsored clinical trials. * Adhere to Research SOP's, Good Clinical Practices, and the study protocols. * Assist in patient recruitment by performing detailed chart reviews and patient interviews. * Discuss study protocols with patients and verify the informed consent documentation. * Review medical history of patients against inclusion/exclusion criteria of studies. * Perform blood draws, process and ship blood/urine specimens per study protocol and IATA regulations. * Schedule all patient research visits and procedures consistent with protocol requirements. * Dispense study medication, collect vital signs, and perform ECGs. * Assist with routine data verification and quality control, ensuring data integrity and consistency with prescribed study protocol. * Complete and maintain case report forms per FDA guidelines and review them against the patient's medical record for completeness and accuracy. * Function in a clinical role by conducting clinical research studies. * Monitor patients and provide information to the medical staff and other staff members to assure optimal outcomes. * Develop written concise research study information and/or tools to be used for the education of staff and the recruitment of patients. * Maintain compliance of protocols and regulatory guidelines for studies performed in the research area. * Act as a resource for other staff members regarding investigational issues or guidelines. * Coordinate the availability and distribution of medications for patients in a timely manner. * Perform phlebotomy for lab work as required and completes all necessary forms. * Responsible for the education of patients in all aspects of the disease process and/or clinical study in which the patient may be involved. * Plan and coordinate the initiation of research study protocols, and the establishment of operating policies and procedures. * Assist the principal investigator, research team, and Regional Director with various administrative tasks associated with the day-to-day operations of research studies and projects. * Plan and coordinate with the research team and Regional Director the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity. * Plan, implement, and maintain data collection and analysis systems in support of the research protocol. * Monitor the progress of research activities; develop and maintain records of research activities, and prepare periodic and ad hoc reports, as required by investigators, administrators, funding agencies, and/or regulatory bodies. * Facilitate assigned clinical trial from start to finish. * Screen participants for all studies independently. * Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research. * Triage phone calls from subjects, be able to answer clinical care questions within the scope of practice; determine when escalation is required. * Adhere to infection control/safety guidelines and confidentiality policies. Core Competencies * Flexible, Detail oriented, Customer focus, Team working, Initiative, Problem solving, Organized General * Adopt the Impact Research culture of respect, integrity and accountability that contribute to an internal environment of teamwork and promote a positive brand image to our external customers. * Incorporate a leadership mindset to your role. * Comply with Impact Research procedures, policies, and regulations relevant to your role. * Successfully completes all Impact Research training requirements (i.e. OSHA, HIPAA, HealthStream, compliance, etc.) * Responsible for compliance with all regulatory requirements and/or guidelines. These requirements/guidelines include, but are not limited to: OSHA, HIPAA, Federal Fraud and Abuse laws. * Computer skills - good working knowledge of MS office. * Ability to communicate effectively with others, both verbally and in writing. * Proven ability to manage time, meet deadlines and prioritize. * Able to maintain standards and professionalism during periods of fluctuating workloads. * Provide professional service to direct customers of Impact Research in all interactions. * Build effective working relationships with other team members. * Manage daily tasks to ensure business needs are consistently met. * Provide professional service to direct customers of One GI in all interactions. * Build effective working relationships with other team members. * Manage daily tasks to ensure business needs are consistently met. Education and Qualifications * High School Diploma or equivalent required. * Associate or Bachelor's degree preferred. * Three+ years previous experience in clinical research for pharmaceutical phase II or III trials required. * Previous GI trials experience preferred. * Clinical experience in an office or hospital setting. * Must maintain current licensure and/or certification. * Basic Life Support certification required. * Knowledge of medical terminology, anatomy, physiology, and pathophysiology. * Familiarity with health care systems, regulations, policies, and functions. * Understanding of clinical research documentation standards. * Knowledge of equipment, supplies, and materials needed for medical treatment. * Understanding of basic laboratory procedures including phlebotomy, preparation, and screening. * Working knowledge of industry standards and regulatory requirements relevant to clinical drug trials. At Iterative Health, we're actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact CandidateAccommodations@iterative.health.

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. Responsibilities include but are not limited to being lead coordinator on a study, executing follow-up visits ongoing studies, query resolution and other study specific tasks. The CRC I will perform daily tasks such as document review, data entry, test material preparation and data collection. This position may coordinate and execute projects assigned by the Clinic Manager while abiding by Good Clinical Practice (GCP) guidelines. JOB FUNCTIONS * Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information * Responds to queries from Quality Assurance and Statistics departments * Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs * Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed to protocol, SOPs and GCPs * Monitor Compliance of panelists * Prepares and is accountable for all Test Material for managed studies * Adheres to study budget * Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents * Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs * Coordinates scheduling subjects for visits * Completes other duties or tasks assigned by Clinic Manager and/or Supervisor JOB COMPLEXITY * Multi-tasking is key IMPACT OF DECISIONS * Make decisions as a study leader ANALYTICAL THINKING/PROBLEM SOLVING * Handle issues with panelists and create solutions * Arrange work for studies Qualifications EDUCATION AND EXPERIENCE * Associate degree or 2 years minimum of relevant work experience with a GED or High School Diploma. * Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies KNOWLEDGE / SKILLS / ABILITIES * Language Skills * Mathematical Skills * Reasoning Skills/Abilities * Computer Skills * Ability to manage and coordinate multiple projects in a fastpaced, highly professional environment. Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

About the role About the Role: We are looking for a meticulous and proactive Clinical Research Study Coordinator to join our dynamic team. In this role, you will oversee and coordinate various aspects of clinical trials, ensuring adherence to regulatory standards and study protocols. You will collaborate closely with the research team, and participants to facilitate the successful execution of research studies. What you'll do Key Responsibilities: Oversee all phases of clinical trials, including participant recruitment, informed consent processes, and data collection. Maintain comprehensive and organized study documentation, such as case report forms, regulatory paperwork, and study logs. Schedule and conduct study visits, follow-ups, and assessments with participants. Ensure adherence to Good Clinical Practice (GCP) guidelines and study protocols. Communicate effectively with Principal Investigators, research staff, and study sponsors to ensure smooth operations. Monitor the progress of studies and report any issues or deviations to the Principal Investigator and sponsor. Assist in the preparation of study-related documentation, including protocols, informed consent forms, and regulatory submissions. Perform data entry tasks while ensuring data integrity and confidentiality. Organize and participate in study meetings, training sessions, and site visits. Qualifications Bachelor's degree in a relevant field (e.g., life sciences, nursing, public health) or equivalent experience. Prior experience in clinical research or a related field is preferred. Familiarity with clinical trial regulations, GCP, and FDA guidelines. Strong organizational, communication, and interpersonal skills. Ability to work both independently and collaboratively within a team. Proficiency in Microsoft Office and clinical trial management software. A valid Phlebotomy Certificate from the USA is required. Additional Consideration: Candidates with prior experience as Medical Assistants (MAs) in pulmonary or respiratory care settings are strongly encouraged to apply. Applicants who have worked 2+ years in a pulmonary office and are familiar with patient assessments, spirometry, or chronic respiratory disease management will find this an excellent opportunity to transition into clinical research. We provide full training and ongoing support for qualified candidates interested in advancing their careers in research coordination. If you are detail-oriented and passionate about clinical research, we invite you to apply and contribute to our mission of advancing medical knowledge through rigorous and ethical 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

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

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!

Clinical Research Coordinator I, Psychiatry Molecular Imaging - (904149) Description Clinical Research Coordinator I - Psychiatry Department - Molecular Imaging DivisionWHY 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 SUMMARYUT Southwestern Medical Center's Molecular Imaging in Psychiatry Program seeks a Clinical Research Coordinator I (CRC I) to help deliver PET and MRI studies designed to clarify the biology of psychiatric and neurologic disease and accelerate the development of imaging biomarkers that can meaningfully improve diagnosis and treatment. Beyond day-to-day study coordination, this position is a platform for professional growth in rigorous clinical research. Working closely with the PI and an expert imaging team, the CRC I will , schedule and manage research visits, maintain inspection-ready regulatory and source documentation, and support high-quality data collection, reporting, and project milestones. The role offers direct exposure to advanced imaging operations, and opportunities to contribute to publications, conference abstracts, and other dissemination activities as studies mature. Success requires independence, sound judgment, and a disciplined commitment to participant safety and data integrity in fast-moving interdisciplinary settings. 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. PreferredExperience Experience supporting PET or MRI research studies, particularly involving investigational radiotracers or pharmacokinetic modeling. Familiarity with Institutional Review Board (IRB) and FDA Investigational New Drug (IND) regulatory processes. Prior exposure with arterial or venous blood sampling in human studies. Working knowledge of REDCap or equivalent databases and familiarity with imaging data management systems or NIH Data Archive submissions. Licenses 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 DUTIESRecruit, screen, consent, and schedule research participants according to IRB-approved protocols. Coordinate complex PET/MR imaging visits and blood sampling procedures in collaboration with chemistry, imaging, and clinical teams. Provide compassionate participant support, including assistance for individuals with cognitive impairment or psychosis, ensuring safety and comfort during all study procedures. Conduct accurate data entry, de-identification, and quality control for imaging and clinical data. Collaborate with imaging physicists to review PET/MR data for completeness and quality assurance. Prepare datasets for upload to the NIH Data Archive and maintain appropriate data documentation. Track and document biospecimen processing, including arterial plasma samples and radiotracer metabolism assays. Maintain regulatory documentation for IRB, FDA (IND), and institutional audits; assist with submissions, renewals, and amendments. Ensure compliance with Good Clinical Practice (GCP), HIPAA, and radiation safety requirements. Serve as liaison between psychiatry investigators, PET/MR technologists, radiochemistry staff, radiology fellows, physicists, and biologists to coordinate scheduling and communication. Contribute to development of standard operating procedures (SOPs) for imaging workflows, data handling, and participant logistics. Assist in training and onboarding future coordinators as the research team expands. 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: 426041 - PY-Coughlin LabSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 9, 2026, 6:23:22 PM

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!

Clinical Research Coordinator I, Neurology - (913828) Description Clinical Research Coordinator I - Neurology Department - Cognitive & Behavioral DivisionWHY 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 SUMMARYUT Southwestern Medical Center is one of the 10 best large employers in the United States and among the top 5 of healthcare employers, according to the America's Best Employers 2022 list compiled by Forbes. UTSW is also ranked as the top healthcare employer for diversity in the US according to the America's Best Employers for Diversity 2022 list compiled by Forbes and Statista; and we are the only healthcare institution listed among the top 20 employers nationally. The Department of Neurology at UT Southwestern Medical Center is a nationally recognized leader in the comprehensive management of neurological conditions. Our vibrant department comprises more than 75 full-time faculty in 12 subspecialty sections, supporting a spectrum of complex and innovative approaches to neurological care, a broad range of novel research programs, and a panoply of educational opportunities for trainees. The department offers access to the latest innovative treatments in one of the most rapidly advancing fields of medicine and features an Advanced Comprehensive Stroke Center and a Level-4 NEAC Epilepsy Center. Through collaborations with the O'Donnell Brain Institute, the department is building state-of-the art facilities for drug and device testing and bringing current and new faculty together for collaborative research on brain disease therapy. Position Summary & Preferred Qualifications/ExperienceThe Cognition & Memory section within the Department of Neurology at UT Southwestern Medical Center is seeking a Clinical Research Coordinator (CRC). Working independently under the Principal Investigator, the CRC will be responsible for carrying out clinical research studies, including but not limited to participant recruitment and enrollment, scheduling study visits, carrying out study procedures, data collection and transfer to data repositories, and maintaining study records. The CRC must be able to work in a multidisciplinary clinical team, display a high degree of initiative, and have excellent interpersonal, organizational, and time management skills. 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 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: 417009 - NE-Cognitive & MemorySchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 16, 2025, 7:58:07 PM