Clinical research coordinator jobs in Plano, TX - 101 jobs

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. About Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity Our Abbott story is one of delivering bold solutions in the face of complex healthcare challenges. At Abbott Electrophysiology (EP), we've been a leader for over 20 years, pioneering one of the first mapping systems, introducing the first contact force ablation catheter and creating a portfolio of products trusted in millions of procedures around the world. We have and will continue to redefine what's possible in an evolving and challenging EP landscape. When you join Abbott EP, you become part of a passionate group of individuals who are dedicated to driving the EP space forward and helping people live longer, fuller lives. We are committed to building a foundation for our people to be successful, investing in their development and growth, and creating a diverse, inclusive culture that welcomes different perspectives, experiences and backgrounds. What You'll Work On Working under general direction, provides engineering, sales, educational and technical support in response to field inquiries from physicians, health care professionals, patients, and field sales staff, involving EP products. Performs work that involves a high degree of independence. Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates their effectiveness and appropriateness. Exercises independent judgment in planning, organizing and performing work; monitors performance and reports status to manager. As a Clinical Associate on the U.S. Abbott EP team, you will provide clinical and technical support in a hospital setting, utilizing EP technology in the treatment of various cardiac arrhythmias. You will join a high-functioning, collaborative team, partnering closely with physicians and hospital staff to support the diagnosis and treatment of abnormal heart rhythms to achieve better patient outcomes. In this role, individuals will exercise independent judgment in planning, organizing, and performing day-to-day tasks. You will identify and routinely use the most effective, cost-efficient, and best business practices to execute processes, regularly communicating insights, feedback, and results to managers and team. Additional responsibilities include: Gaining foundational knowledge of EP through a structured training program with a strong emphasis on hands-on learning and practical application. Providing regional EP procedural case coverage in an Electrophysiology lab and/or operating room setting. Acting as a clinical interface between the medical community and the business. Demonstrating the ability to build and sustain credible clinical relationships with customers and sharing product expertise accordingly. Demonstrating a thorough command of all EP products, including technical details, software utilization, and capabilities. Providing engineering, sales, education, and clinical support on the safe and effective use of Abbott EP products, including cardiac mapping, diagnostic, and therapy systems. Supporting EP Sales Representatives in the following areas: Collaborating with sales personnel; Facilitating regional training seminars; Participating in clinical studies/data collection; Troubleshooting; and, Leading/supporting new product in-service trainings and/or demonstrations to physicians, nurses, and sales representatives. Continuously develops engineering, sales and technical skills aligned with the overall territory strategy, including learning from senior sales personnel and management. Staying up-to-date on the latest industry developments, regulatory requirements, and maintains strong knowledge of company and competitor products, market trends, and strategic goals. Providing management with feedback on market trends and customer insights to inform strategic decisions and guide next-generation product development. Participating in occasional travel for in-person instruction and live procedure coverage. Required Qualifications * Bachelors Degree or equivalent experience. * Verification that you will satisfy all vendor credentialing requirements, which may include vaccination for COVID-19. If you require a medical or religious accommodation from these requirements or if you would like to understand more about these requirements, please advise HR so that we can provide additional information and if needed, we can explore any needed accommodation(s). Apply Now Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: ********************** Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at *************** on Facebook at ************************ and on Twitter @AbbottNews. The base pay for this position is $50,700.00 - $101,300.00. In specific locations, the pay range may vary from the range posted.

Fortrea's Clinical Pharmacology Team is hiring a CRA 2 with Phase I experience in Dallas, Texas! WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, eg. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned Perform other duties as assigned by management Requirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 2+ years of Clinical Monitoring experience Phase I experience preferred Must reside in Dallas Texas area The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) - Flex Plan Employee recognition awards Multiple ERG's (employee resource groups) Target Pay Range: $100-113K #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

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.

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

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

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

Lead Clinical Research Coordinator, Psychiatry Molecular Imaging - (904445) Description Lead Clinical Research Coordinator- Psychiatry Department - Molecular Imaging DivisionWHY UT SOUTHWESTERN?With over 75 years of excellence in Dallas-Fort Worth, Texas, UT Southwestern is committed to excellence, innovation, teamwork, and compassion. As a world-renowned medical and research center, we strive to provide the best possible care, resources, and benefits for our valued employees. Ranked as the number 1 hospital in Dallas-Fort Worth according to U. S. News & World Report, we invest in you with opportunities for career growth and development to align with your future goals. Our highly competitive benefits package offers healthcare, PTO and paid holidays, on-site childcare, wage, merit increases and so much more. We invite you to be a part of the UT Southwestern team where you'll discover a culture of teamwork, professionalism, and a rewarding career! JOB SUMMARYUT Southwestern Medical Center's Molecular Imaging in Psychiatry Program seeks a Lead Clinical Research Coordinator to help build and lead the operational backbone for PET and MRI studies designed to clarify the biology of psychiatric and neurologic disease and accelerate the development of imaging biomarkers to meaningfully improve diagnosis and treatment. The Lead CRC will provide primary stewardship of tightly coordinated visits, managing imaging and clinical data, ensuring regulatory compliance, and collaborating with teams in Psychiatry, Radiology, and the Advanced Imaging Research Center. This role may include 1-2 direct reports, offering leadership experience and a clear pathway for continued career growth as the program expands. The role also offers high ownership, direct exposure to advanced imaging operations, and opportunities to contribute to publications, conference abstracts, and other dissemination activities as studies mature. Ideal candidates bring strong communication skills, confidence in complex imaging settings, and a track record of proactive, independent execution. 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 Experience4 years of clinical research experience with Bachelor's Degree 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. May consider additional years of experience or advanced degree in lieu of education or experience, respectively. PreferredExperienceExperience supporting PET or MRI research studies, particularly involving investigational radiotracers or pharmacokinetic modeling. Familiarity with Institutional Review Board (IRB) and FDA Investigational New Drug (IND) regulatory processes. Prior exposure with arterial or venous blood sampling in human studies. Working knowledge of REDCap or equivalent databases and familiarity with imaging data management systems or NIH Data Archive submissions. Licenses and Certifications(BLS) BASIC LIFE SUPPORT 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 of SOCRA certification a plus. JOB DUTIESRecruit, screen, consent, and schedule research participants according to IRB-approved protocols. Coordinate complex PET/MR imaging visits and blood sampling procedures in collaboration with chemistry, imaging, and clinical teams. Provide compassionate participant support, including assistance for individuals with cognitive impairment or psychosis, ensuring safety and comfort during all study procedures. Conduct accurate data entry, de-identification, and quality control for imaging and clinical data. Collaborate with imaging physicists to review PET/MR data for completeness and quality assurance. Prepare datasets for upload to the NIH Data Archive and maintain appropriate data documentation. Track and document biospecimen processing, including arterial plasma samples and radiotracer metabolism assays. Maintain regulatory documentation for IRB, FDA (IND), and institutional audits; assist with submissions, renewals, and amendments. Ensure compliance with Good Clinical Practice (GCP), HIPAA, and radiation safety requirements. Serve as liaison between psychiatry investigators, PET/MR technologists, radiochemistry staff, radiology fellows, physicists, and biologists to coordinate scheduling and communication. Contribute to development of standard operating procedures (SOPs) for imaging workflows, data handling, and participant logistics. Assist in training and onboarding future coordinators as the research team expands. Maintains required subject documentation for each study protocol. Directly 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 provide supervision to other members of the research team as necessary. May perform research billing activities, as needed, based on size of department (including linking patient calendars Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Assists PI/supervisor with daily activities of the research team and functions as a liaison between clinical research investigators and various organizations/departments and agencies including, but not limited to HRPP, FDA, Sponsored Programs, and affiliated hospitals. Coordinates data management and collection for national (larger/more complex) research studies. Serves as 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. Assists and monitors and/or maintain research study budgets. Assists the PI with the fiscal management of the trial. Ensures that the patient care charges are allocated appropriately for various research studies. 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 in the assigned clinical trial management system, electronic medical record and/or other required data entry systems. 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: 426041 - PY-Coughlin LabSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 9, 2026, 6:20:20 PM

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

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

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

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

Clinical Research Coordinator II, Neurosurgery - (906766) Description Clinical Research Coordinator II - Neurosurgery DepartmentWHY 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. 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. PreferredExperiencePrevious experience Coordinating Industry Clinical Trials for Investigative Devices or Experiment DrugsExperience working with FDA IDE' (Investigative Drug Exemptions) s or IND (Investigative New Drug) Initial IRB Submission or Amendments ExperienceExperience working with WCG or other centralized IRB's Licenses 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: 416000 - NS-Department AdministrationSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Nov 19, 2025, 5:45:44 PM

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

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

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

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 temporary Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position at our Dallas, TX site. This assignment will last between 2-4 months. A Clinical Research Coordinator (temporary) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is preferred. Bilingual - Spanish preferred. 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. *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1