Clinical research associate jobs in Waxahachie, TX - 170 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.

**_IQVIA Biotech is now hiring for CRA 2 with a minimum of 1 year of on-site monitoring and will also consider CRA 1 candidates with a minimum of 6 months on-site monitoring experience. Must have experience monitoring in oncology solid tumor._** _IQVIA Biotech is a full-service CRO purpose-built to serve biotech sponsors. With over 25 years of experience, we offer agile, therapeutically aligned solutions and trusted partnerships that help bring breakthrough treatments to patients faster._ **Job Overview** We are seeking a dedicated Clinical Research Associate (CRA) to join our team and play a key role in ensuring the successful execution of clinical trials. In this position, you will be responsible for monitoring and managing clinical sites to ensure compliance with study protocols, regulatory requirements, and sponsor expectations. Your work will directly contribute to the integrity and quality of clinical research data. **Key Responsibilities** + Conduct all types of site visits-selection, initiation, monitoring, and close-out in alignment with the contracted scope of work, Good Clinical Practice (GCP), and ICH guidelines. + Collaborate with site staff to implement and track subject recruitment strategies that align with project timelines and enrollment goals. + Deliver protocol and study-specific training to site personnel and maintain consistent communication to manage expectations and resolve issues. + Assess site performance and adherence to the protocol, escalating quality concerns as needed to ensure compliance and data integrity. + Monitor study progress by tracking regulatory submissions, subject enrollment, case report form (CRF) completion, and resolution of data queries. + Ensure that essential documents are collected and maintained in both the Trial Master File (TMF) and the Investigator Site File (ISF) in accordance with regulatory standards. + Document site management activities, visit outcomes, and follow-up actions through detailed reports and correspondence. + Work closely with cross-functional project teams to support study execution and ensure alignment with project goals. + Depending on the project, you may also support site-level recruitment planning and financial management, including invoice collection and budget tracking. **Qualifications** + Bachelor's degree in life sciences or health-related field (or equivalent experience). + Requires at least 1 year of on-site monitoring experience. + Strong understanding of GCP, ICH guidelines, and regulatory requirements. + Ability to travel as required by the project. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $71,900.00 - $169,300.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

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.JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and 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. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity We are seeking an experienced, high caliber Clinical Research Scientist to perform professional who provides scientific expertise throughout the development and implementation of clinical studies, clinical evaluations, or risk management. Writes / manages clinical trial protocols, protocol amendments, clinical study project timelines, clinical evaluations (planning and reports), risk master lists, clinical trial registrations and results postings, and scientific publications. Interacts with various study support groups and cross-functional teams in order to assist in clinical strategy, the development of study or clinical evaluation plans, and project or report deliverables. Interacts with regulatory agencies as needed, and will use their scientific and medical knowledge in order to provide directives to staff as well as study sites as appropriate. Job Duties: Facilitates communication between Sales and Marketing, R&D, Clinical R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs or Clinical Science, Risk Management, Clinical Project Management, external CROs or Medical Writers, Training, and/or Senior Management and investigational sites as directed by your manager. Conducts team meetings, drafting and sending routine correspondence (e.g., newsletters) and by presenting regular updates to senior staff. Participates in site selection process by conducting meetings with appropriate departments and individuals to review and revise draft site list as necessary, and by communicating the final site list to team members. Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines. Allocates resources by utilizing the appropriate project management tools.; 5. Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction. Writes study protocols, protocol amendments, informed consents, clinical evaluation plans and reports, risk master lists, and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice. Interprets Phase I to IV clinical study results in preparation for new product applications by evaluating scientific literature and publications, analyzing scientific and risk data and staying abreast of current clinical practice. Presents scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings, investigational meetings and regulatory agency meetings. Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc. Participates in and supports audits. Qualifications: Education: Bachelors Degree (± 16 years) In related field or an equivalent combination of education and work experience Experience/Background Minimum 8 years Related work experience with a complete understanding of specified functional area. Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/ relationships. Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has broad knowledge of various technical alternatives and their potential impact on the business. Apply Now * Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year. 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 and @AbbottGlobal. The base pay for this position is $99,300.00 - $198,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY:Clinical Affairs / StatisticsDIVISION:CRM Cardiac Rhythm ManagementLOCATION:United States > Texas > Plano : 6901 Preston RoadADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Yes, 5 % of the TimeMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: ************************************************************ EEO is the Law link - Espanol: ************************************************************

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 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.

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

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

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!

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

Reporting to the Associate Vice President of Horticulture, the Horticulture Research and Trials Coordinator will assist with horticultural trials at the Arboretum which include taking data, analyzing, and writing review along with the supervision of the Trials Supervisor. Responsible for a wide variety of work assignments that will be both technical and maintenance related. Support all trial related projects with office duties and computer work. Contribute to team effort. DUTIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Appropriately and accurately enter data for record collection and interpretation and assist with trial activities. Act as liaison with companies involved in plant testing. Write all research reports in a timely and accurate manner. Maintain plant trials website and social media. Coordinate any events pertaining to the trials program; Field Day, CAST, etc. Oversee the Trials Supervisor with maintenance of plants in trial gardens. Responsible for accurate labeling of all plant material in trial beds and trial containers. Implement and maintain plant accession records in the trial garden. Assist with production of slides and other graphic materials and conduct presentations as needed. Assist with collections data and cataloging. Perform limited field pest control and herbicide applications. Perform field and greenhouse duties that may include planting, propagation, and at times basic garden upkeep as needed. Oversee greenhouse growing of all trial plant material. Supervise all trial garden volunteers. Responsible for taking pictures and measurements of trial plants as needed. Oversee the effective training, scheduling and development/evaluation of personnel; assure that all personnel documentation is processed in a timely manner, including safety compliance and required training. Responsible for horticulture back of house upkeep and cleaning. Responsible for ordering supplies and materials following the proper PO process. Responsible for coordination of pesticide, herbicide, and chemical management and storage. Liaison with TDA, EPA, and any other pesticide management authorities. Assist with special event projects and horticulture demonstrations. Assist with budget process with research expenses. SKILLS AND QUALIFICAITONS: Lifting of up to 30 pounds when necessary repetitively bend/stoop, move across property and work in all weather conditions and follow approved safety guidelines Good verbal and written communication skills; basic computer skills (working knowledge of Excel, MS Office, Outlook, etc.) Ability to manage multiple tasks through use of effective organizational and time-management skills. Ability to apply pesticides and chemicals with training provided; obtain and maintain Texas pesticide license. Ability to pass a background check, drug screening, and physical evaluation Ability to effectively lead and support staff. Valid Driver's license to drive garden vehicles. Ability to work flexible hours, including nights, weekends and holidays. Bachelor of Science degree in Horticulture or three years equivalent greenhouse experience preferred. KEY COMPETENCIES : Adhere to the Arboretum's Core Values: Community, Learning, Innovation, and Sustainability To help you stay energized, engaged, and inspired, we offer a wide range of benefits including comprehensive healthcare, a 401K, and Paid Time Off (PTO). The mission of the Dallas Arboretum and Botanical Garden is to be a garden for all that enriches lives through beauty, learning, and connection. We are a world-class sanctuary where people and plants flourish in the natural environment. The Dallas Arboretum is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, age, color, ancestry, national origin, place of birth, religion, sex, sexual orientation, gender identity and expression, military or veteran status, genetic characteristics or disability unrelated to job performance.

Department: Research Operations Shift: First Shift (United States of America) Standard Weekly Hours: 40 The Clinical Research Coordinator (CRC) is a Research Administration Office (RAO) team member responsible for assisting with the planning and implementation of clinical research studies. The CRC works closely with members of the research team to ensure protocol expectations are executed appropriately. As an instrumental member of the clinical team, the CRC balances patient visits, data entry, and clerical responsibilities associated with clinical trials. Education & Experience: Must meet one of the following: Associates Degree, Bachelor's Degree, 4 years of Clinical Research Experience in lieu of education Experience Equivalencies: Associates Degree: 1-2 years of relevant research and/or healthcare experience BA in a Healthcare related field: ≤1 year of Healthcare experience BA in a non-Healthcare related field: 1-2 years of healthcare experience Certification/Licensure: BLS required PALS recommended Knowledge, Skills, & Abilities Attentive to detail with excellent organization skills Self-motivated Excellent written, oral & team communication skills Team oriented Intermediate knowledge of Outlook and schedule management Basic Medical Terminology required Professional and courteous Customer Service Pediatric experience (preferred) Competency in basic computer skills required (word processing, spreadsheets, etc.) About Us: Cook Children's Health Care System Cook Children's Health Care System offers a unique approach to caring for children because we are one of the country's leading integrated pediatric health care delivery organizations. Patients benefit from the integrated system because it allows Cook Children's to use all of its resources to treat a patient and allows for easy communication between the various companies by physicians with a focus on caring for children and adolescents. Cook Children's is an equal opportunity employer. As such, Cook Children's offers equal employment opportunities without regard to race, color, religion, sex, age, national origin, physical or mental disability, pregnancy, protected veteran status, genetic information, or any other protected class in accordance with applicable federal laws. These opportunities include terms, conditions and privileges of employment, including but not limited to hiring, job placement, training, compensation, discipline, advancement and termination.

Clinical Research Coordinator I - Psychiatry Department - Molecular Imaging Division 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 SUMMARY UT Southwestern Medical Center's Molecular Imaging in Psychiatry Program seeks a Clinical Research Coordinator I (CRC I) to help deliver PET and MRI studies designed to clarify the biology of psychiatric and neurologic disease and accelerate the development of imaging biomarkers that can meaningfully improve diagnosis and treatment. Beyond day-to-day study coordination, this position is a platform for professional growth in rigorous clinical research. Working closely with the PI and an expert imaging team, the CRC I will , schedule and manage research visits, maintain inspection-ready regulatory and source documentation, and support high-quality data collection, reporting, and project milestones. The role offers direct exposure to advanced imaging operations, and opportunities to contribute to publications, conference abstracts, and other dissemination activities as studies mature. Success requires independence, sound judgment, and a disciplined commitment to participant safety and data integrity in fast-moving interdisciplinary settings. BENEFITS UT 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 coverage * 100% 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 Benefit * Wellness programs * Tuition Reimbursement * Public Service Loan Forgiveness (PSLF) Qualified Employer * Learn more about these and other UTSW employee benefits! EXPERIENCE AND EDUCATION Required * Education Bachelor's Degree or higher degree in medical or science related field * Experience 1 year of clinical research experience May consider additional years of experience or advanced degree in lieu of education or experience, respectively. Preferred * Experience Experience supporting PET or MRI research studies, particularly involving investigational radiotracers or pharmacokinetic modeling. Familiarity with Institutional Review Board (IRB) and FDA Investigational New Drug (IND) regulatory processes. Prior exposure with arterial or venous blood sampling in human studies. Working knowledge of REDCap or equivalent databases and familiarity with imaging data management systems or NIH Data Archive submissions. * Licenses and Certifications (BLS) BASIC LIFE SUPPORT Licensure may be required based on research study protocols or affiliate location requirements. (CPRAED) CPR AED Licensure may be required based on research study protocols or affiliate location requirements. ACRP or SOCRA certification a plus JOB DUTIES * Recruit, screen, consent, and schedule research participants according to IRB-approved protocols. * Coordinate complex PET/MR imaging visits and blood sampling procedures in collaboration with chemistry, imaging, and clinical teams. * Provide compassionate participant support, including assistance for individuals with cognitive impairment or psychosis, ensuring safety and comfort during all study procedures. * Conduct accurate data entry, de-identification, and quality control for imaging and clinical data. * Collaborate with imaging physicists to review PET/MR data for completeness and quality assurance. * Prepare datasets for upload to the NIH Data Archive and maintain appropriate data documentation. * Track and document biospecimen processing, including arterial plasma samples and radiotracer metabolism assays. * Maintain regulatory documentation for IRB, FDA (IND), and institutional audits; assist with submissions, renewals, and amendments. * Ensure compliance with Good Clinical Practice (GCP), HIPAA, and radiation safety requirements. * Serve as liaison between psychiatry investigators, PET/MR technologists, radiochemistry staff, radiology fellows, physicists, and biologists to coordinate scheduling and communication. * Contribute to development of standard operating procedures (SOPs) for imaging workflows, data handling, and participant logistics. * Assist in training and onboarding future coordinators as the research team expands. SECURITY AND EEO STATEMENT Security This position is security-sensitive and subject to Texas Education Code 51.215, which authorizes UT Southwestern to obtain criminal history record information. EEO UT 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.

Printpack, a leading manufacturer of flexible packaging, is seeking a candidate to fill the position of Plant Trial Coordinator in their Converting plant in Grand Prairie, TX. This position will report to the Continuous Improvement Manager and help to improve trial effectiveness, clarify expectations, and enhance the working relationship between manufacturing and product development through direct and local support in locations that have a high level of complexity or volume of trials. This is a day shift position, but requires some flexibility based on daily work demands. This position may also include overtime when needed. Key Responsibilities: * Enhance the customer experience through increasing the success rates of trials and onboarding -manage customer onboarding through pre-trial preparation, specification review for materials and optimization opportunities, trial/SSO calls, attend and support critical trials. * Share technical knowledge between plants and product development - attend plant scheduling meetings, share critical dates for orders, communicate with Planner Analysts on trial dates and materials needed, verify QC tests needed, provide technical expertise on plant assets, participate in plant PLT meetings. * Identify gaps through process and trial retrospectives - oversee trial execution, prioritize, and attend critical trials, document trial progress and gaps, create action item reviews as needed, utilize OBIEE and MES data to drive analysis. * Develop solutions for existing gaps by clarifying responsibilities across roles and functions - request spec revisions, become site administrator for PRISM trial module, provide support to elevate significant acute or chronic issues, coordinate problem solving sessions when needed. Knowledge, Skills & Abilities: * Strong computer skills including Excel, Word, and PowerPoint. * Strong PRISM (Printpack internal production reporting system) knowledge. * Ability to multitask and work self-directed. * Demonstrated ability to execute tasks in a timely manner. * Strong problem solving, decision making, and organization skills. * High stress tolerance and ability to operate effectively under pressure. * Strong verbal and written communication skills. * Experience managing projects. * Experience leading teams. * Experience operating equipment in a Printpack Converting Plant is preferred. * Experience troubleshooting processes in a Printpack Converting Plant is preferred. Physical Demands: * Must be able to stand, walk, sit, climb, balance, stoop, kneel, crouch crawl, climb stairs and ladders, and work on elevated platforms. * Must be willing to wear personal protective equipment including but not limited to protective eyewear, steel-toed shoes, and hearing protection. * Must be able to work on the production floor at production machines for entire production shifts when needed for trials, troubleshooting, or Standard Operating Condition (SOC) validation. * Must be able to work on a computer and utilize tools for virtual meetings as needed. Travel Requirements: Travel is not expected in this role but could include occasional trips to Atlanta or other Printpack or customer facilities. Printpack is proudly an equal-opportunity employer. We are committed to creating an inclusive environment. Embracing diversity enhances our work culture and is vital to our success. We do not discriminate based on race, color, religion, sex (including pregnancy), national origin, gender identity, sexual orientation, marital/parental status, genetic information, age, national origin, ancestry, ethnicity, disability, marital status, military or veteran status or affiliation, or any other characteristic protected under applicable law. To view your rights and government notices, please see the links below: Know Your Rights - Conozca sus Derechos - Your Rights Under USERRA (dol.gov) - FMLA - FMLA (Spanish) - Polygraph Protection - Right to Work - Right to Work (Spanish) Printpack is committed to helping individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you need a reasonable accommodation to assist you with your application for employment or job search, please get in touch with us by sending an email to ****************************. Please include in your email a brief description of the accommodation you are requesting and the position for which you are interested in applying.

Salary Range: $97,583-$130,111About UsOncor Electric Delivery Company LLC, headquartered in Dallas, is a regulated electricity transmission and distribution business that uses superior asset management skills to provide reliable electricity delivery to consumers. Oncor (together with its subsidiaries) operates the largest transmission and distribution system in Texas, delivering power to nearly 4 million homes and businesses and operating more than 143,000 miles of transmission and distribution lines in Texas.Position SummaryAs a Load Research Coordinator at Oncor, you'll coordinate the designs and implements load research samples to provide statistically valid customer and class load profile characteristics. Designs and develops systems and procedures to construct class load profiles and perform analyses to support cost of service, rate design, load forecasting, load profiling, financial admin and regulatory filing requirements.Key Roles & Responsibilities: Develop and administer the sample design, computer programs and survey implementation necessary to provide statistically valid customer and rate class load characteristics. Develop systems to construct class load profiles utilized in support of cost of service, rate design, load forecasting, load profiling, financial admin and regulatory filing load data requirements Design new and enhance existing systems developed to generate data schedules to satisfy regulatory filing requirements. Refresh all customer and class level load profiles and statistics supplied by Company to ERCOT for use in the development of load profile models for settling the market. Also provide all characteristics data, population expansion weights and sample design documents. Communicate with internal and external users of load research to evaluate and satisfy needs of the research environment. Education, Experience, & Skill Requirements Bachelor's degree in statistics, mathematics, engineering, computer science, or business administration with 4+ years of work-related experience as a data analyst and/or project manager. OR High School diploma, GED, or equivalent with 4+ years of work-related experience as a data analyst and/or project manager required. Possess knowledge of load research techniques, statistics, statistical analysis and sample design procedures and methodologies. Have analytical experience and knowledge of load data characteristics. Experience in analyzing and modeling customer load characteristics and determining long range research requirements. Experience designing statistical samples to accurately represent customer and population load characteristics. Expertise in Python, SQL, Word, PowerPoint, and Excel. Measures of Success Production of load research data to meet regulatory filing requirements. Achievement of quantitative, qualitative and cost metrics by assigned work group. Interaction with internal and external stake holders to resolve issues in accordance with Company policies and standards. Demonstrates ability to perform and coordinate work with minimum supervision. Timely development of statistical load research samples. BenefitsAt Oncor, we offer a comprehensive set of benefits, compensation and performance management programs designed specifically to attract, retain, motivate and reward our high-performing workforce. Our supportive and inclusive culture allows every team member the opportunity to thrive and make a difference. We invest in our employee's success and well-being by offering such things as: Annual incentive program. Competitive health and welfare benefits (medical, dental, vision, life insurance). Ability to earn wellness incentives (up to $2,300 in 2026 as an Employee only) and other wellbeing resources. 401k with dollar-for-dollar company match up to 6%. 401k match with student debt program. Cash balance pension plan. Adoption Assistance. Mental health resources. Employee resource groups. Tuition reimbursement. Competitive vacation, 10 company holidays and 2 personal holidays. Paid parental leave. Salary continuation for up to 6 months for approved employee illness or injury. Other perks such as commuter benefits, electric vehicle incentive program, appliance purchase plan. Participation in benefit programs for employees in collective bargaining units is subject to the applicable collective bargaining agreement.

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

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.

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.