Clinical research coordinator jobs in Richardson, TX - 189 jobs

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

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. * Identification and hiring of appropriate clinic staff, preparation of annual reviews and handing of performance issues, if any, with the assistance of the Human Resources Manager * Oversees the training, mentoring and career development of all clinic staff * Understands requirements for all studies and communicates to all personnel/departments involved in each study * Works closely with recruiting manager to ensure study panelists meet protocol requirements * Assists in clinic staff scheduling to ensure all studies are staffed appropriately * Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures * Oversees the clinic conduct of each study and/or delegates supervisors to oversee when unavailable * Ensures that supplies and equipment needed from clients are available for studies as necessary * Identifies and provides solutions to clinical trial issues and/or risks * Ensures inventory of internal supplies needed for studies is at a level to support current and upcoming studies * Contributes to the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents * Identifies, develops, and reviews company policies and procedures * Works closely with sponsor's and monitors during site qualification, monitoring, and auditing visits * Identifies areas of improvement, especially related to quality and efficiency, and implements solutions * Understanding of the site's P&L and how clincal operations can impact the P&L * Manages staff and resources while considering the P&L for the site Qualifications * Bachelor's Degree, preferably in science * 5+ years in Clinical Research * Minimum of 4 years of Supervisory/Leader experience * Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment. * Ability to develop collaborative relationships with internal and external stakeholders. * Strong decision-making/analytical skills * Proficiency with Microsoft Office applications * Knowledge of GCP/CLP guidelines and Federal Regulations related to the conduct of clinical trials, NIH training and CCRC/CCRA certification a strong plus Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

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. 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!

The Clinical Research Coordinator 1 assists various Principal Investigators (PI), through delegated authority, in conducting clinical trials during all phases of trials including pre-study implementation through study closure per federal, state and Institutional guidelines. This position will learn to assist Principal Investigators on more complex studies and seek guidance from more senior roles when needed. **ESSENTIAL FUNCTIONS OF THE ROLE** Implements various protocols for assigned research projects with appropriate departments throughout the organization by interacting with PIs, clinical managers and supervisors. Creates, facilitates, and/or executes a variety of different project workflows based on the needs of the clinical trial protocol. Examples of workflows include, providing in-service education for healthcare professionals, and working with Pharmacy to ensure a smooth project flow. Ensures that appropriate billing or charging mechanisms are in place for research charges related to research studies. Requires familiarity with research study budgets and provides feedback on budgets for new clinical trials. Performs research subject informed consent and entry into appropriate research studies ensuring that all inclusion and exclusion criteria are met. Collaborates and coordinates with regulatory compliance including preparing Institutional Review Board (IRB) materials for approval of protocol amendments and submitting Investigational New Drug (IND) Safety forms. Ensures that all study documents are complete and that records are retained per federal, state and institutional standards. Obtains knowledge of departmental functions through reading literature, attending workshops, seminars and conferences and participating in professional organizations. Conducts and coordinates study-monitoring visits. Conducts audits and quality checks of research studies to check the accuracy, integrity and consistency of research studies. **KEY SUCCESS FACTORS** Research certification or other certifications per specialty area preferred. Strong written and oral communication skills. Strong computer skills, including Microsoft Office. Ability to manage time sensitive projects in order to meet deadlines. Strong ability to establish and maintain effective working relationships. **BENEFITS** Our competitive benefits package includes the following - Immediate eligibility for health and welfare benefits - 401(k) savings plan with dollar-for-dollar match up to 5% - Tuition Reimbursement - PTO accrual beginning Day 1 Note: Benefits may vary based upon position type and/or level **QUALIFICATIONS** - EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification - EXPERIENCE - Less than 1 Year of Experience As a health care system committed to improving the health of those we serve, we are asking our employees to model the same behaviours that we promote to our patients. As of January 1, 2012, Baylor Scott & White Health no longer hires individuals who use nicotine products. We are an equal opportunity employer committed to ensuring a diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

The Opportunity: You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier". How you'll contribute: We are seeking an experienced Sr. CRA who has leadership experience to lead our clinical trial. The Sr. CRA is responsible for delivering high-quality clinical trial execution across assigned studies. This role combines advanced monitoring expertise with hands-on clinical trial management responsibilities, including vendor oversight, study planning, site management, and cross-functional coordination. The ideal candidate brings strong leadership, independent judgment, and the ability to proactively identify risks while ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs. What you'll bring: * Occasionally, lead day-to-day operational management of assigned clinical studies from start-up through close-out. * Develop, review, and maintain essential study documents (monitoring plans, manuals, trackers). * Manage study timelines, deliverables, and milestones to ensure high-quality execution. * Support budget development, contract review, and vendor selection as needed. * Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance. * Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues. * Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues. * Ensure site documentation meets regulatory and audit readiness standards. * Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance. * Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues * Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues. * Ensure site documentation meets regulatory and audit readiness standards. Qualifications and Requirements: Experience * 5-8+ years of clinical research experience, including independent on-site and remote monitoring. * Prior experience in a Sr. CRA or CTM role within a sponsor, biotech, or CRO environment. * Demonstrated vendor oversight and project coordination experience. * Prefer Experience within Oncology * Bachelor's degree in life sciences, nursing, pharmacy, or related field (or equivalent experience). Skills & Competencies * Strong knowledge of ICH-GCP and regulatory requirements. * Excellent communication, presentation, and relationship-building skills. * Ability to work independently, manage multiple priorities, and adapt to fast-paced environments. * Strong analytical, problem-solving, and decision-making capabilities. * Proficiency in CTMS, EDC, eTMF, and common clinical systems.

We are seeking a Clinical Trial Manager (CTM) who will be responsible for overseeing the day-to-day operations of multiple clinical trials-from initiation through close-out-working across internal teams and with external CRO partners. This role offers a unique opportunity to contribute meaningfully to trial strategy, execution, and reporting, while operating in a collaborative and fast-paced environment. Essential Duties and Responsibilities * Manage the planning, execution, and oversight of clinical trials (both internally managed and CRO-managed) in alignment with company goals, timelines, and budgets * Manage CRAs, internal or externally, for the execution of clinical trials * Serve as primary contact for internal stakeholders, CROs, and investigational sites * Ensure regulatory compliance, GCP adherence, and proper documentation throughout the trial lifecycle * Coordinate closely with investigative physicians and site staff, supporting protocol compliance and patient safety * Ensure meticulous attention to data accuracy, study documentation, and trial conduct * Overseeing and managing the trial budget and ensuring efficient use of resources * Track trial progress and proactively identify and mitigate risks or delays, proactively resolve operational issues * Generate regular status updates and presentations for leadership, including timelines, enrollment metrics, and key performance indicators * Assist in the creation and review of protocols, CRFs, training materials, regulatory documents, site audits, and quality processes * Cross-team collaboration regarding data management, finances, engineering to ensure proper communication and deliverables are met * Travel up to 30% for site visits, investigator meetings, and industry conferences, as they arise * Travel (approximately) once a month for in-office collaboration * Help field and respond to clinical questions based on your practical experience Qualifications Required: * Bachelor's degree in life sciences, nursing, or relevant field * 6+ years of experience in clinical research, including 3+ years managing trials in a sponsor or CRO environment * Experience managing medical device trials * Demonstrated ability to oversee multiple trials or various study designs simultaneously * Strong communication and organizational skills with high attention to detail * Proven track record of preparing trial updates and presenting senior leadership on study progress Preferred: * Prior hands-on clinical research experience or nursing experience in wound care * Experience in early-stage environments or small companies * Familiarity with EDC systems, QA, and regulatory documentation and requirements Knowledge, Skills, and Abilities: * 6+ years of clinical research experience (medical device industry strongly preferred) * 3+ years as a Clinical Trial Manager or similar role as part of your research experience * Experience managing and supporting physician investigators * Exceptional attention to detail - you catch what others miss * Proven ability to manage multiple projects in a fast-paced, dynamic environment * Deep knowledge of GCP, ISO 14155, and medical device regulations Physical Requirements: The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Very limited physical effort required to perform normal job duties * Extensive use of telephone, virtual/video conference calls, and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * Some travel may be required Equal Employment Opportunity: Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws

We are seeking a Clinical Trial Manager (CTM) who will be responsible for overseeing the day-to-day operations of multiple clinical trials-from initiation through close-out-working across internal teams and with external CRO partners. This role offers a unique opportunity to contribute meaningfully to trial strategy, execution, and reporting, while operating in a collaborative and fast-paced environment. Essential Duties and Responsibilities Manage the planning, execution, and oversight of clinical trials (both internally managed and CRO-managed) in alignment with company goals, timelines, and budgets Manage CRAs, internal or externally, for the execution of clinical trials Serve as primary contact for internal stakeholders, CROs, and investigational sites Ensure regulatory compliance, GCP adherence, and proper documentation throughout the trial lifecycle Coordinate closely with investigative physicians and site staff, supporting protocol compliance and patient safety Ensure meticulous attention to data accuracy, study documentation, and trial conduct Overseeing and managing the trial budget and ensuring efficient use of resources Track trial progress and proactively identify and mitigate risks or delays, proactively resolve operational issues Generate regular status updates and presentations for leadership, including timelines, enrollment metrics, and key performance indicators Assist in the creation and review of protocols, CRFs, training materials, regulatory documents, site audits, and quality processes Cross-team collaboration regarding data management, finances, engineering to ensure proper communication and deliverables are met Travel up to 30% for site visits, investigator meetings, and industry conferences, as they arise Travel (approximately) once a month for in-office collaboration Help field and respond to clinical questions based on your practical experience Qualifications Required: Bachelor's degree in life sciences, nursing, or relevant field 6+ years of experience in clinical research, including 3+ years managing trials in a sponsor or CRO environment Experience managing medical device trials Demonstrated ability to oversee multiple trials or various study designs simultaneously Strong communication and organizational skills with high attention to detail Proven track record of preparing trial updates and presenting senior leadership on study progress Preferred: Prior hands-on clinical research experience or nursing experience in wound care Experience in early-stage environments or small companies Familiarity with EDC systems, QA, and regulatory documentation and requirements Knowledge, Skills, and Abilities: 6+ years of clinical research experience (medical device industry strongly preferred) 3+ years as a Clinical Trial Manager or similar role as part of your research experience Experience managing and supporting physician investigators Exceptional attention to detail - you catch what others miss Proven ability to manage multiple projects in a fast-paced, dynamic environment Deep knowledge of GCP, ISO 14155, and medical device regulations Physical Requirements: The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Very limited physical effort required to perform normal job duties Extensive use of telephone, virtual/video conference calls, and face-to-face communication requiring accurate perception of speech Extensive use of keyboard requiring repetitive motion of fingers Regular sitting for extended periods of time Some travel may be required Equal Employment Opportunity: Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws

We are seeking a Clinical Trial Manager (CTM) who will be responsible for overseeing the day-to-day operations of multiple clinical trials-from initiation through close-out-working across internal teams and with external CRO partners. This role offers a unique opportunity to contribute meaningfully to trial strategy, execution, and reporting, while operating in a collaborative and fast-paced environment. Essential Duties and Responsibilities * Manage the planning, execution, and oversight of clinical trials (both internally managed and CRO-managed) in alignment with company goals, timelines, and budgets * Manage CRAs, internal or externally, for the execution of clinical trials * Serve as primary contact for internal stakeholders, CROs, and investigational sites * Ensure regulatory compliance, GCP adherence, and proper documentation throughout the trial lifecycle * Coordinate closely with investigative physicians and site staff, supporting protocol compliance and patient safety * Ensure meticulous attention to data accuracy, study documentation, and trial conduct * Overseeing and managing the trial budget and ensuring efficient use of resources * Track trial progress and proactively identify and mitigate risks or delays, proactively resolve operational issues * Generate regular status updates and presentations for leadership, including timelines, enrollment metrics, and key performance indicators * Assist in the creation and review of protocols, CRFs, training materials, regulatory documents, site audits, and quality processes * Cross-team collaboration regarding data management, finances, engineering to ensure proper communication and deliverables are met * Travel up to 30% for site visits, investigator meetings, and industry conferences, as they arise * Travel (approximately) once a month for in-office collaboration * Help field and respond to clinical questions based on your practical experience Qualifications Required: * Bachelor's degree in life sciences, nursing, or relevant field * 6+ years of experience in clinical research, including 3+ years managing trials in a sponsor or CRO environment * Experience managing medical device trials * Demonstrated ability to oversee multiple trials or various study designs simultaneously * Strong communication and organizational skills with high attention to detail * Proven track record of preparing trial updates and presenting senior leadership on study progress Preferred: * Prior hands-on clinical research experience or nursing experience in wound care * Experience in early-stage environments or small companies * Familiarity with EDC systems, QA, and regulatory documentation and requirements Knowledge, Skills, and Abilities: * 6+ years of clinical research experience (medical device industry strongly preferred) * 3+ years as a Clinical Trial Manager or similar role as part of your research experience * Experience managing and supporting physician investigators * Exceptional attention to detail - you catch what others miss * Proven ability to manage multiple projects in a fast-paced, dynamic environment * Deep knowledge of GCP, ISO 14155, and medical device regulations Physical Requirements: The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Very limited physical effort required to perform normal job duties * Extensive use of telephone, virtual/video conference calls, and face-to-face communication requiring accurate perception of speech * Extensive use of keyboard requiring repetitive motion of fingers * Regular sitting for extended periods of time * Some travel may be required Equal Employment Opportunity: Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow-because at LivaNova, we don't just treat conditions - we aspire to alter the course of lives. The Associate Clinical Project Manager will be involved and assist with the management and execution of clinical studies in accordance with the applicable domestic and international government regulations, Clinical Investigation Plans, and Standard Operating Procedures. Additionally they will assist with the development of effective clinical trial strategies, preliminary project timelines, and budgets for clinical project(s) to ensure successful product development and worldwide marketing efforts. General Responsibilities Coordinate project deliverables such as team meetings, project budgets and timelines, and systems to track study metrics. Assist Clinical Management with the development and planning of clinical study strategies, design, protocols, and other study-related documents and tools. Oversee and provide clinical input for the design of the Case Report Forms and electronic databases. Assist with and coordinate preparation of regulatory applications, amendments, questions from the authorities, supplements, reports, and advisory panel presentations needed to conduct studies and approve products. Assist and drive clinical site selection, activation, management and any close-out activities throughout the conduct of the study including all necessary documentation. Prepare and give clinical presentations to physicians, clinical study staff, agents and distributors, as required. Monitor or co-monitor clinical study sites to ensure compliance with the approved study protocol, plans and objectives which may include reviewing clinical monitoring reports. Assure clinical studies are adequately managed to meet the protocol objectives and schedules. If applicable, support Data Monitoring Committees (also called Data Safety Monitoring Boards) and other committees/consultants established to support the studies. Assist data management staff with clinical data review and collection of data from sites to maintain integrity by reviewing protocol deviations, adverse events, data inconsistencies, outliers, other issues as identified. Develops and executes risk based study management process and plan according to study-specific risk indicators and thresholds. Assist with management of study vendors for compliance to study plans, objectives and vendor contracts, including task management of labs and/or CROs, if applicable. Helps to ensure sponsor and site compliance to domestic and international government regulations and guidelines. Effectively communicate with LivaNova study management, participating sites, and any vendors on issues, questions and/or study updates. Create, update, and maintain site administrative files and trial master files (electronic and/or paper) to ensure audit-readiness at all times. Maintain accurate and up-to date study tracking documents (eg enrollment, regulatory approvals and renewals, payments) and systems (eg CTMS, EDC). For premarket studies, instruct warehouse and field staff in clinical device distribution and recovery. Maintain device accountability plan and report. Coordinates and assists with the data review, analysis and preparation of the clinical study reports and coordinates their deliveries. Coordinates closeout of sites/study, archive study documents. Skills and Experience Minimum prior work experience of 4+ years as a Clinical Research Nurse or equivalent role supporting clinical trial project management at a medical device/drug company, clinical research site, or CRO. Knowledge of international regulations and guidelines (ISO14155/GCP) and clinical study design and implementation. Working knowledge of medical terminology. Capability and willingness to learn device function. Ability to interface effectively with medical professionals. Strong analytical and organization skills, with excellent attention to detail and accuracy. Project oversight and tracking capability. Good oral and written communication skills. Ability to work autonomously with excellent organizational skills and ability to prioritize assignments while handling various projects simultaneously. Experience with electronic data capture (EDC) and clinical trial management systems (CTMS). Demonstrated ability to perform in a team environment. Ability to travel as necessary to clinical centers to establish and manage clinical studies. Experience as a Project Coordinator/Manager is a plus. Education Minimum Bachelor's Degree in Nursing (a Master's Degree in Nursing is also accepted for candidates who did not complete an undergraduate nursing program). Travel Requirements This position requires regular business travel of 25% or more of the time. Pay Transparency A reasonable estimate of the annual base salary for this position is $95,000 - $105,000 + discretionary annual bonus. Pay ranges may vary by location. Employee benefits include: Health benefits - Medical, Dental, Vision Personal and Vacation Time Retirement & Savings Plan (401K) Employee Stock Purchase Plan Training & Education Assistance Bonus Referral Program Service Awards Employee Recognition Program Flexible Work Schedules Welcome to impact. Welcome to innovation. Welcome to your new life.

Job Title: Clinical Research Coordinator Type: Contract To Hire Contractor Work Model: Onsite Elevate your career in clinical research! Joule, in partnership with a leading client, is recruiting for a crucial, full-time Clinical Research Coordinator (CRC) position in the greater Dallas area. We are looking for a motivated CRC to manage a varied caseload spanning high-impact therapeutic areas such as Vaccines, GI, and Endocrinology. This position offers a unique chance to broaden your skill set by engaging with multiple trial types simultaneously. To ensure effective site performance, this role requires a 100% onsite commitment. Successful candidates must hold a Bachelor's degree and bring at least three years of dedicated experience as a Clinical Research Coordinator. Duties and Responsibilities: - Supports enrolling patients onto the clinical trial through screening, enrollment and follow up of eligible subjects according to protocol requirements - Ensures the protection of study patients by verifying informed consent procedures and adheres to protocol requirements/compliance - Collects, completes, and enters data into study specific case report forms or electronic data capture systems Requirements: + Bachelor's degree required, 2yr/AS degree is ok with at least 2 years of relevant clinical research experience and CCRC certification + Must have at least three solid years as a Clinical Research Coordinator (CRC) working on sponsor-initiated interventional drug and/or device studies + Organizational and prioritizing capabilities System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. Ref: #568-Clinical System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Job DescriptionClinical Research Coordinator (Onsite) Dallas, TX Contract Role Ready to make an impact in medical research? This Clinical Research Coordinator role offers the chance to play a vital part in advancing patient care through high-quality, hospital-based clinical trials. The position involves coordinating study activities, collecting data, ensuring compliance, and collaborating with physicians, sponsors, and research teams to keep studies on track and accurate. Company Summary This organization leads with purpose-conducting ethical, precise, and innovative clinical research that improves lives. The team is dedicated to advancing healthcare by fostering collaboration, scientific excellence, and integrity in every trial conducted. What's In It for You Be part of meaningful, life-changing research that drives medical progress Enjoy a steady weekday schedule-no weekends or holidays Gain hands-on experience with industry-sponsored clinical trials Work in a collaborative, professional environment where your work truly matters Qualifications Bachelor's degree required (science or healthcare preferred) 3+ years of clinical research experience, preferably in a hospital setting Experience with industry-sponsored trials and EMR systems Certified Clinical Research Coordinator (CCRC) preferred Take the next step in your research career-apply today to become a Clinical Research Coordinator and help shape the future of patient care! A further detailed conversation would allow us both to determine if this position would be a good fit for you. Please share this information with anyone who you think may be qualified and interested to learn more about these fast-moving opportunities. Contact today for more details. If you or someone you know is interested in learning more, please contact: ???? Phone: ************ ???? Email: *********************** ClinicalResearch #CRCJobs #ClinicalTrials #HealthcareCareers #DallasJobs #ResearchCoordinator #NowHiring #MedicalResearch #OnsiteJob #TexasCareers

Clinical Research Coordinator I, Pediatrics - (908579) 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 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 Department of Pediatrics and Division of Critical Care Medicine is seeking a Research Coordinator to recruit patients, obtain informed consent, assist with regulatory documentation and perform clinical research projects within the ICU at Children's Medical Center Dallas. An ideal candidate would have experience/familiarity with the environment within a critical care setting while also having experience in facilitating study development and implementation, assisting with patient recruitment, knowledge regarding regulatory requirements and data collection skills. Key Responsibilities:Coordinate regulatory guidelines both internally and externally. Monitor and maintain data quality and integrity. Ensure adherence to internal and external deadlines. Assist with monitoring and maintaining data quality and integrity. Collaborate on day-to-day issues. Assist with preparing scientific and regulatory information for national meetings and conferences. Coordinate, communicate, and provide study related training to internal and external research staff. Coordinate concierge travel services for research patients. Consent and conduct study related procedures. Ensure lab supplies are sent and received from external sites. Ensure specimens received from external sites were properly shipped, stored properly, and managed following guidelines throughout the study. Qualifications:Proven experience in clinical research. Strong problem-solving skills and a proactive team approach. Ability to receive and integrate feedback from multiple collaborators and colleagues. The ideal candidate will be an effective communicator with a strong track record in clinical research trials and a commitment to advancing our research objectives. Occasional weekends, evenings and Travel may be required. BENEFITSUT Southwestern is proud to offer a competitive and comprehensive benefits package to eligible employees. Our benefits are designed to support your overall wellbeing, and include:PPO medical plan, available day one at no cost for full-time employee-only coverage100% coverage for preventive healthcare-no copay Paid Time Off, available day one Retirement Programs through the Teacher Retirement System of Texas (TRS) Paid Parental Leave BenefitWellness programs Tuition ReimbursementPublic Service Loan Forgiveness (PSLF) Qualified EmployerLearn more about these and other UTSW employee benefits!EXPERIENCE AND EDUCATIONRequiredEducationBachelor's Degree or higher degree in medical or science related field Experience1 year of clinical research experience May consider additional years of experience or advanced degree in lieu of education or experience, respectively. PreferredLicenses and Certifications(BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements. ACRP or SOCRA certification a plus JOB DUTIESDirectly interacts with clinical research participants, as required, for the research study. Interacts via telephone, telehealth or in-person. Coordinate regulatory aspects of the trial including maintaining and developing regulatory information to comply with industry standards, University policies, FDA requirements or other hospital policies Coordinate and schedule study procedures as per protocol. Approved study protocols which have order sets built may be pended by the non-licensed coordinator with oversight by PI. When outside of protocol, presents evidence and provides options (within scope of protocol) to PI. Screen, recruit, enroll and follow subjects according to protocol guidelines. May also assist with the consent process Maintain and coordinate data collection information required for each study which may also include developing CRF's or data collection tools Assist in developing and implementing research studies to include writing clinical research protocols. Conduct study procedures according to the protocol with proper training and check offs to maintain scope of work Requires familiarity with research budgets to assist with or develop study budgets. May perform research billing activities, as needed, based on size of department (including linking patient calendars). May review and abstract information from medical records for verification of eligibility for trials, as needed based on size of department. Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards. Review research study protocols to ensure feasibility Assist in developing website or other social media for marketing/recruiting of clinical research study Develop proficiency in the clinical trial management system, electronic medical record and other required data entry systems Maintain subject level documentation Duties performed may include one or more of the following core functions: a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records. Performs other duties as assigned. SECURITY AND EEO STATEMENTSecurityThis position is security-sensitive and subject to Texas Education Code 51. 215, which authorizes UT Southwestern to obtain criminal history record information. EEOUT Southwestern Medical Center is committed to an educational and working environment that provides equal opportunity to all members of the University community. As an equal opportunity employer, UT Southwestern prohibits unlawful discrimination, including discrimination on the basis of race, color, religion, national origin, sex, sexual orientation, gender identity, gender expression, age, disability, genetic information, citizenship status, or veteran status. Primary Location: Texas-Dallas-5323 Harry Hines BlvdWork Locations: 5323 Harry Hines Blvd 5323 Harry Hines Blvd Dallas 75390Job: Research & LaboratoryOrganization: 423022 - PD-Research AdminSchedule: Full-time Shift: Day JobEmployee Status: RegularJob Type: StandardJob Posting: Jan 8, 2026, 5:28:46 PM

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

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

DM Clinical Research is looking to hire an Unblinded Clinical Research Coordinator II to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials. Duties & Responsibilities: Compound and dispense prescribed IP as needed by Sponsor approved protocol Study IP management Provide training and guidance for new team members Assist in all aspects of company start up activities as required Supervise and maintain records of all medications Ensure compliance with study-specific blinding plans Perform regular audits on the clinical data to assess percent completeness and accuracy Assist in onboarding training for new members Ensure external sites' regulatory documents and required site certifications are up to date Provide consultative support regarding the preparation and dosing of drugs Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials Understand and apply all applicable site procedures Ensure receipt and proper storage of IP and bioretention samples, including temperature reporting Develop operating procedures, guides and best practices for data entry portals and project workflows Interact with Principal Investigator, sponsor, study manager and other study coordinators to ensure all aspects of protocols and study requirements are understood. Any other duties or tasks assigned by the manager KNOWLEDGE & EXPERIENCE Education: Associates Degree required or 2 years of formal educational coursework Bachelor's degree, preferred Secondary or Foreign Medical Graduate, preferred Experience: 2+ years of Clinical Research experience, inclusive of in-clinic experience, required 1+ year of Clinical Research Coordinator experience, Blinded or Unblinded, required 1+ year utilizing CRIO, preferred Credentials: LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant), preferred Pharmacy Technician Certification, preferred Completion of DMCR-required training, including GCP, OSHA and IATA Knowledge and Skills: Computer proficiency, especially Word, Excel, Outlook, and Google Suite products. Excellent communication and customer service skills, both written and verbal Excellent time-management skills Ability to remain composed under pressure and high-stress situations Outgoing personality Well-organized with attention to detail. Must be able to multitask. Bilingual (Spanish) preferred

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

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