Clinical research associate jobs in Denton, TX - 111 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.

Clinical Research Associate (SOAR) Multi TA - Texas ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What will you be doing? Works on multiple trials within the Cross Therapeutic areas - Start up focus Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. Build strong relationships with site personnel to facilitate a smooth onboarding process. Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. Proactively identify and address any issues that may delay study initiation or affect trial deliverables. Maintain precise documentation to ensure readiness for inspections. Support sites during the activation phase until they achieve “Green Light” status for site opening. Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. What do you need to have? Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences Must be located in Texas, near a major airport. Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials Knowledge of several therapeutic areas Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all of our study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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.

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!

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!!!

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Dallas, TX. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience preferred Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

Clinical Research Coordinator II, Internal Medicine Cardiology - (918068) 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 SUMMARYWorks under the direction of an Investigator(s) with limited 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. The CRC II will be responsible for coordination of site-based clinical research for faculty in the Preventive Cardiology Section of the Division of Cardiology. The coordinator will be responsible for all administrative activities related to the trial including startup, regulatory submission, contracting and budgeting, participant recruitment, enrollment, and all study procedures. Experience with enrollment and operations of site-based clinical trial research is required, including prior experience in using electronic health records. Key attributes include attention to detail, problem-solving abilities, and strong interpersonal 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 in medical or science related field Experience2 years years 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 may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED 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 (non-clinical and clinical procedures). Interacts via telephone, telehealth or in-person. Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies. Coordinates and schedules procedures as per research study. A non-licensed coordinator may pend study order sets with oversight by PI. Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). May also assist with the consent processes. Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools. Assists in developing and implementing research studies, may include writing clinical research protocols. Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service. May assist the PI on the fiscal management of the trial including budget preparation. Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. May perform research billing activities, as needed, based on size of department (including linking patient calendars). Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time. Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies. Prepares protocols for Institutional Review Board (IRB) submission. May also submit amendments and continuing review documents. Provides in-service training to all study team members and communicates to involved groups. Reviews research study protocols to ensure feasibility requirements of the study. Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study. Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems. Maintains required subject documentation for each study protocol. 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: 415014 - IM-CardiologySchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 16, 2026, 8:19:29 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

Clinical Research Assistant will perform work in one or all of the following areas Phlebotomy, Data Entry, and Administrative Assistant responsibilities in support of the clinical research team. The Clinical Research Assistant will assist in the management of multiple clinical trials according to the study protocol, perform collection of clinical data points, and provide seamless customer service to the patients attending the site. Responsibilities Include but not limited to: Complete training and ensure adherence of GCPs, SOPs, IATA, and HIPPA Ensure compliance with all clinical trial protocols Ensure compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC, and HIPPA. Assist research staff with Phase II-IV clinical trials from start through closure Enter visits, patient recruitment in Real Time Clinical Trial Management System (CTMS) Aid research department is meeting contracted and expected recruitment goals Engage in quality assurance of all study documents and data prior to monitoring visits Support central and local marketing campaigns by entering recruitment data, contacting patients and scheduling. Coordinate office visits for trial participants based on the protocol Perform phlebotomy, collect, process and ship clinical specimens Assist in patient care visits and procedures according to protocol Receive medication, confirm temperature in range and maintain temperature logs Perform ECGs Engage in patient recruitment Assist with entry into Electronic Data Capture (EDC) data queries are resolved Participate in Investigator meetings and trainings during the course of the trial Generate PowerPoint presentations Create and organize new patient charts, lab and other required supplies prior to the patient visit. Gain access to Institutional Review Boards. Maintain regulatory binders, CRFs, subject charting, and source documents Maintain the Investigator Site Files Assist with keeping Institutional Review Boards (IRB) documents, Electronic Data Capture (EDC) Clinical Trials Management System (CTMS) and Interactive Web Response Systems (IWRS) current Will support central and local marketing campaigns by contacting potential subjects and scheduling Qualifications Possess a minimum of two (2) years experience in the clinical research or closely related field Bachelors degree or relevant work experience. Bilingual (Spanish), a plus.

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!

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

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Dallas, TX. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: Assisting trial Investigator in screening and review of potential study participants eligibility Maintaining case report forms, charts and documentation Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements Collecting and entering data as necessary Assist management with potential new hire selection and shadowing process Assist with study start-up, maintenance, and close-out of studies as needed for those on the team Ability to be flexible with study assignments Qualifications Clinical Research Coordinator with 1-2 years of experience Phlebotomy experience preferred Excellent verbal & written communication skills Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines Extensive clinical trial knowledge through education and/or experience Successful completion of GCP Certification and Advanced CRC preferred Detail-oriented Familiarity with the Code of Federal Regulations as they pertain to human subject protection Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

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.

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

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, 2:36:33 PM

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

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

Clinical Research Assistant II, Internal Medicine - (918426) 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 SUMMARYWorks 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. Support and assist GIM Principle Investigator and research staff by performing a variety of duties such as assisting with preparation of required documents for IRB review and approval, preparing protocols, library reference materials search for necessary project information/literature reviews; compiling data and producing reports to be used for analysis of research findings; and assisting with developing and submitting grants and reports. Will assist with recruitment and retention of both English and Spanish speaking research study participants. 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: 415019 - IM-Gen Int MedSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 22, 2026, 2:28:45 PM

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!