Clinical research associate jobs in Rockwall, TX - 90 jobs

Job Title: Clinical Research Associate II (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.

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. * Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager * Oversees the training, mentoring and career development of all clinic staff * Understands requirements for all studies and communicates to all personnel/departments involved in each study * Works closely with recruiting manager to ensure study panelists meet protocol requirements * Assists in clinic staff scheduling to ensure all studies are staffed appropriately * Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures * Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable * Ensures that supplies and equipment needed from clients are available for studies as necessary * Identifies and provides solutions to clinical trial issues and/or risks * Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies * Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents * Identifies, develops, and reviews company policies and procedures * Works closely with sponsor's and monitors during site qualification, monitoring, and auditing visits * Identifies areas of improvement, especially related to quality and efficiency, and implements solutions * Understanding of the site's P&L and how clincal operations can impact the P&L * Manages staff and resources while considering the P&L for the site Qualifications * Bachelor's Degree, preferably in science * 5+ years in Clinical Research * Minimum of 4 years of Supervisory/Leader experience * Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment. * Ability to develop collaborative relationships with internal and external stakeholders. * Strong decision-making/analytical skills * Proficiency with Microsoft Office applications * Knowledge of GCP/CLP guidelines and Federal Regulations related to the conduct of clinical trials, NIH training and CCRC/CCRA certification a strong plus 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.

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.

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.

Lead Clinical Research Assistant, Otolaryngology - (911110) Description Lead Clinical Research Assistant - Otolaryngology Department*This position will be based at Children's Hospital*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 SUMMARYThe Otolaryngology Department is looking to hire a full time Lead Clinical Research Assistant to assist with ongoing clinical research studies. The employee works under the direction of an Investigator(s) with limited supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. The employee will also work on complex studies in a lead role, under the direction of the Research Manager and the PI. 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 EDUCATIONRequiredEducationHigh School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree or higher in medical or science related field Experience4 years of experience with High School Diploma or 2 years of experience with Associate's Degree or 1 year of experience with Bachelor's Degree or higher Prior experience in the UTSW clinical research mentoring program is highly desirable, and participation in the UTSW clinical research mentoring program may count as additional experience. PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT may be required based on research study protocol or affiliate location requirements. (CPRAED) CPR AED may be required based on research study protocol or affiliate location requirements. ExperienceBi-Lingual in English and Spanish is highly preferred JOB DUTIESAssists with participant screening and recruitment for complex trials or multiple research studies at any given time. Conducts and documents consent for participants in studies. Develops consent plans and documents for participants. Independently corrects and documents incomplete, inaccurate, or missing data for more complex studies. Understands visit schedules, criteria and protocol requirements for complex trials; schedules research visits, etc. Completes research protocol related tasks. Reviews and abstracts information from medical records including eligibility criteria. Recruits and enrolls patients in research study that may include consenting patients. Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation. Assists with data queries and possible edits for accuracy. Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions. Maintains existing databases and ensures data integrity. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order. Assists with collecting and processing specimens following established procedures/protocols. With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document. 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. May provide working supervision or direction of lower level Clinical Research Assistants. Performs QA/QC clinical analysis and data checks using various databases based on trial. Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO). Assist and prepare research records for formal sponsor audits or internal audits. 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: 421000 - OT-Department AdministrationSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 8, 2025, 7:36:33 PM

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

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 Job Purpose This position will be located in the Arlington Office and will report directly to the Clinical Operations Officer. The position will help to identify, evaluate, and recruit potential patients for ongoing studies and is responsible for managing data collection. Texas Retina Associates is Texas' largest, most experienced ophthalmology practice focused specifically on the diagnosis, medical and surgical management of diseases of the retina and vitreous. Our fellowshipped and specialty trained physicians care for the most complicated retina conditions such as ocular cancer and uveitis. This physician owned medical group provides services at 14 locations throughout the DFW metroplex, Waco, Wichita Falls and Lubbock. Essential Duties Data collection, process data queries and ensure resolution. Identify adverse events and reports per protocol guidelines. Assist in the planning and design of source documents for study protocols as required Update and review regulatory documents to include annual IRB approvals, protocol amendments, and safety reports. Responsible for the timely completion of identified study documents including case report forms. Responsible for ensuring compliance with FDA and GCP guidelines. Conduct pre-study, initiation, monitoring, and close out visits with sponsor representatives Greet patients in a cordial, friendly and prompt manner. Escort patients to examining rooms, verify patient information and makes necessary documentation to patient charts. Present patient history summary and alert Ophthalmologist to changes in visual acuity, elevated extraocular pressure or blood pressure, etc. Administer topical ophthalmic or oral medications. Counsel patients in the office and on the phone concerning physician's orders, use of drops, drugs, and answers questions. Maintain knowledge of operation and maintenance of clinical equipment, drugs, and supplies. Obtains all appropriate consent forms Contribute to maintaining a clean and sterile environment Adhere to all OSHA and Infectious Waste Procedures; Perform tasks in support of the Clinical Research Department as needed Maintain compliance with all practice procedures and protocols Maintain HIPAA compliance for all patient information Notify appropriate staff in a timely manner regarding adequate supplies Cleaning and Care of Ophthalmic Instruments Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. Minimum Education and Experience High school diploma (or GED) One year of experience as a Clinical Research Assistant in an Ophthalmic practice required. Retinal practice experience preferred. Training in medical terminology required. Experience with NextGen and Patient Management preferred. Perform triage per specific office protocol procedures. Must be able to recognize and appropriately respond to urgent / emergency situations per protocol. Ability to read, write and communicate effectively in English, both orally and in writing. Excellent interpersonal skills to deal effectively with patients, patient's family members, physicians, clinicians and administrators. Ability to work in a dynamic, fast paced environment Meticulous attention to detail. Skills and Specifications Strong analytical and organizational ability. Strong ability to listen, answer all questions as simply as possible and act when needed. Excellent computer skills. Complete all other duties as assigned. Physical Requirements Sedentary with prolonged sitting and working at computer. Prolonged periods of standing, walking and bending. Must be able to lift up to 30 lbs. maximum and occasionally lifting and/or carrying such articles as reports, files and small items. Have the hand eye coordination and manual dexterity required to perform all duties.

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!

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.

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 Assistant I, Cardiology - (883755) 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 SUMMARYThis Clinical Research Asst (CRA) I will support the 4th and 5th waves of the Dallas Hearts and Minds Study (DHMS), each of which will involve recalling ~1,000 participants for an in-person diabetes-focused visit. DHMS is a continuation of the Dallas Heart Study, a longitudinal, observational study of more than 3,000 participants that began in 1999. The goal of the newest study stages is to use continuous glucose monitoring (CGM) to characterize glucose patterns in persons with and without diabetes to understand risk factors for diabetes and other cardiometabolic diseases. The CRA I will recruit and actively guide participants through these research visits (up to 15 participants/week) and conduct phlebotomy, place a CGM, administer surveys, etc. The ideal CRA I is be English-Spanish bilingual, has experience with phlebotomy, specimen processing, and Redcap. This is a grant-funded role. This position works 100% on campus. 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 EDUCATIONRequiredEducationHigh School Diploma or GED PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED may be required based on affiliate location requirements JOB DUTIESEnters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation. Assists with data queries and possible edits for accuracy. Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions. Maintains existing databases and ensures data integrity. Understands visit schedules, criteria and protocol requirements for routine and low complexity trials (e. g. , questionnaire, data registry, scripted); schedules research visits. Assists research staff by completing research protocol related tasks. Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO). Reviews and abstracts information from medical records including eligibility criteria. Recruits and enrolls patients in research study that may include consenting patients after training and with supervision. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order. With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols. Assists in preparing studies for closeout, (e. g. packing files, documenting files for storage, shipping extra supplies back to sponsor). With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required. 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 STATEMENTSecurity This position is security-sensitive and subject to Texas Education Code 51. 215, which authorizes UT Southwestern to obtain criminal history record information. To the extent this position requires the holder to research, work on, or have access to critical infrastructure as defined in Section 113. 001(2) of the Texas Business and Commerce Code, the ability to maintain the security or integrity of the critical infrastructure is a minimum qualification to be hired and to continue to be employed in the position. EEO StatementUT 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: 415014 - IM-CardiologySchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Dec 29, 2025, 5:32:27 PM

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

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!

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.

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 1 year of clinical experience, for our Additionally, 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. Psychology experienced with knowledge regarding the psychiatric rating scale is 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!!!

Clinical Research Assistant II, Digestive and Liver - (916444) 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 SUMMARYThis position supports Dr. Mack C. Mitchell on his research endeavors. Dr. Mack is Vice President for Medical Affairs at UT Southwestern Medical Center and the Nancy S. and Jeremy L. Professor of Gastroenterology. He is principal investigator for an NIH sponsored clinical research study on liver disease related to alcohol and has authored or co-authored numerous papers and chapters on alcohol and liver diseases. This role works under the direction of an Investigator(s) with general supervision, to provide ongoing data management for local and national research studies and may coordinate observational (non-treatment/treatment) trials/studies. May provide supporting role for more complex studies under the direction of the PI, Clinical Research Coordinator and/or Clinical Research Lead. Bilingual in English and Spanish highly preferred. 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 EDUCATIONRequiredEducationHigh School Diploma or Associate's Degree in medical or science related field or Bachelor's Degree medical or science related field and no prior experience Experience2 years experience with High School Diploma or 1 year experience with Associate's Degree PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT may be required based on affiliate location requirements. (CPRAED) CPR AED may be required based on affiliate location requirements. JOB DUTIESUnderstands visit schedules, criteria and protocol requirements for low complexity trials (e. g. , questionnaire, data registry, scripted); schedules research visits. Assists research staff by completing research protocol related tasks. Reviews and abstracts information from medical records including eligibility criteria. Enters data into case report forms or other data collection system based on research study. Assists with maintenance of study level documentation. Assists with data queries and possible edits for accuracy. Compiles data for regulatory requirements and /or deadlines for local or sponsor submissions. Maintains existing databases and ensures data integrity. Performs QA/QC clinical analysis and data checks using various databases based on trial. Assists with preparing annual reports and/or modifications to institutional review board (IRB). This may include reportable events (UPIRSO). Assist and prepare research records for formal sponsor audits or internal audits. Recruits and enrolls patients in research study that may include consenting patients after training and with supervision. With adequate training and supervision, assists with participant screening and recruitment for more complex trials. Conducts and documents consent for participants in studies. Assists with the development of consent plans and documents for participants. Identifies incomplete, inaccurate, or missing data for more complex studies and works with lead coordinator to correct errors. Assists with ordering and maintaining research supplies following university/department procedures, ensuring that equipment is in good working order. With adequate training and supervision, assists with collecting and processing specimens following established procedures/protocols. Assists in preparing studies for closeout, (e. g. packing files, documenting files for storage, shipping extra supplies back to sponsor). With adequate training/credentialing and supervision, performs study procedures such as phlebotomy, vital signs, and EKG's needed for research study. Based on research study, other procedures/equipment/services may be required. May perform patient care (basic skills) under the direction of PI following scope of work document. 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: 415016 - IM-Digest & LiverSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 9, 2026, 3:19:55 PM