Clinical Trial Coordinator jobs at Kaiser Permanente - 757 jobs

Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities. Position Summary The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators. Key Responsibilities Coordination of Clinical Trials: Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies. Study Management: Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders. Participant Coordination: Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants. Regulatory and Compliance Oversight: Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times. Data Management: Enter, review, and verify data in EDC systems and ensure timely query resolution. Team Coordination & Leadership: Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability. Communication & Reporting: Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes. Qualifications Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred). Minimum 3-5 years of experience in clinical research coordination. Strong understanding of GCP, ICH, and FDA regulations. Exceptional coordination, multitasking, and communication skills. Experience with EDC systems and clinical trial management software preferred. CCRC/CCRP certification a plus. Why Join Denali Health Work with a mission-driven team advancing clinical research accessibility. Competitive salary and comprehensive benefits package. Professional growth and leadership opportunities. Collaborative environment focused on innovation and patient care. To Apply: Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ******************** with the subject line “Clinical Research Coordinator III - Stone Mountain.”

About Us We're Maimonides Health, Brooklyn's largest healthcare system, serving over 250,000 patients each year through the system's 3 hospitals, 1800 physicians and healthcare professionals, more than 80 community-based practices and outpatient centers. At Maimonides Health, our core values H.E.A.R.T drives everything we do. We uphold and maintain Honesty, Empathy, Accountability, Respect, and Teamwork to empower our talented team, engage our respective communities and adhere to Planetree's philosophy of patient-centered care. The system is anchored by Maimonides Medical Center, one of the nation's largest independent teaching hospitals and home to centers of excellence in numerous specialties; Maimonides Midwood Community Hospital (formerly New York Community Hospital), a 130-bed adult medical-surgical hospital; and Maimonides Children's Hospital, Brooklyn's only children's hospital and only pediatric trauma center. Maimonides' clincal progams rank among the best in the country for patient outcomes, including its Heart and Vascular Institute, Neuroscience Institute, Boneand Joint Center, and Cancer Center. Maimonides is an affiliate of Northwell Health and a major clinical training site for SUNY Downstate College of Medicine. Overview Maimonides is currently seeking a Clinical Trials Support Specialist. Responsibilities We currently have a unique full time opportunity for a Clinical Trials Support Specialist in our Cancer Center Administration Department. Qualifications We require: * Bachelor's of Science in Biology or Chemistry; Master's preferred. * 2 years of research experience in the medical field or an advanced degree in a Biology or Chemistry required. Pay Range USD $66,779.00 - USD $66,779.00 /Yr. Equal Employment Opportunity Employer Maimonides Medical Center (MMC) is an equal opportunity employer.

Are you looking to make meaningful impact with your research/technical experience? Working daily in close partnership with Interventional key clinical partners - as well as global and local GE Healthcare colleagues - you will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. **Job Description** **Responsibilities** + Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities. + Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership (contributing to letters of support, research proposals, supporting identified grant submissions). + Support adoption of new technology or clinical applications through advocacy and evidence. + Participate in customer presentations regarding use of Interventional products for institution research purposes. + Closely connected with GEHC global modality clinical and R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. + Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations + Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. + Grow technology leadership mindshare through joint scientific presentations and publications. + Install/upgrade research equipment and software & prototypes + Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures + Represent the global modality technical, scientific and product expertise in USCAN to support local clinical teams and best-in-class customer experience on new products. + Study new technology concepts and leverage expertise to move initiatives forward. Note: + No sponsorship available for this role now or in the future to work in the United States.. **Qualifications** + PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. + 3+ years of experience in Interventional healthcare industry or research. + Knowledge of Interventional procedures, anatomies, clinical practice. + Excellent written and verbal communication skills. + Excellent customer relationship management and collaboration skills. + Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas. + Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task. + Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. + Able to individually lead complex projects with autonomy, rigor, drive & competence + Ability to travel ( + Quality, Compliance, and Continuous Improvement focus **Desired Characteristics** + 5 years' experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics. + Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) + Demonstrated record of innovation and development. + History of publications, clinical/non-clinical experiments, knowledge in statistics + Programming / Image processing experience + Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity. Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. \#LI-BR3 \#LI-Remote We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $97,600.00-$146,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. **Additional Information** GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer (****************************************************************************************** . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. **Relocation Assistance Provided:** No

EQUAL EMPLOYMENT OPPORTUNITY: UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. DEPT MARKETING STATEMENT: UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks Research Scientists to advance decision-grade evidence from real-world data to study and understand human health. H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data. H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.g., transcriptomics, proteomics, pathogen genomics). Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources. Researchers at H-COR collaborate across all five UTMB schools. JOB DESCRIPTION\: Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB. Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care. Assures competence as a fully trained scientist in a specific discipline or area of expertise. ESSENTIAL JOB FUNCTIONS: Leading and contributing to high-impact health and clinical outcomes research Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNorm Implementing modern causal-inference strategies (e.g., target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) Collaborating across UTMB's schools on defined research programs Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy Presenting research at professional meetings and conferences Participating in H-COR's monthly works-in-progress seminars MINIMUM QUALIFICATIONS: Ph. D, M.D, D.O., or D.V.M in related field and one year of related experience. PREFERRED QUALIFICATIONS\: PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) A track record in health and clinical outcomes methods Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) Fluency in at least two of R, Python, SAS, and SQL Excellent scientific writing and communication Evidence of peer-reviewed publications commensurate with career stage Experience with OMOP and HL7 FHIR data models Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods Clinically oriented NLP and time-aware feature extraction Familiarity with multi-omics data structures and cautious EHR-omics linkage Experience in HPC or cloud settings (e.g., TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility Mentorship of analysts or trainees A record of effective, cross-disciplinary collaboration in an academic health-sciences environment SALARY: Commensurate with experience.

DEPT MARKETING STATEMENT: UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks Research Scientists to advance decision-grade evidence from real-world data to study and understand human health. H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data. H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.g., transcriptomics, proteomics, pathogen genomics). Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources. Researchers at H-COR collaborate across all five UTMB schools JOB DESCRIPTION: Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB. Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care. Assures competence as a fully trained scientist in a specific discipline or area of expertise. ESSENTIAL JOB FUNCTIONS: Leading and contributing to high-impact health and clinical outcomes research Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNorm Implementing modern causal-inference strategies (e.g., target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) Collaborating across UTMB's schools on defined research programs Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy Presenting research at professional meetings and conferences Participating in H-COR's monthly works-in-progress seminars MINIMUM QUALIFICATIONS: Ph. D, M.D, D.O., or D.V.M in related field and one year of related experience. PREFERRED QUALIFICATIONS\: PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) A track record in health and clinical outcomes methods Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) Fluency in at least two of R, Python, SAS, and SQL Excellent scientific writing and communication Evidence of peer-reviewed publications commensurate with career stage Experience with OMOP and HL7 FHIR data models Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods Clinically oriented NLP and time-aware feature extraction Familiarity with multi-omics data structures and cautious EHR-omics linkage Experience in HPC or cloud settings (e.g., TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility Mentorship of analysts or trainees A record of effective, cross-disciplinary collaboration in an academic health-sciences environment SALARY: Commensurate with experience. EQUAL EMPLOYMENT OPPORTUNITY: UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

**Galveston, Texas, United States** Research Academic & Clinical UTMB Health Requisition # 2506214 **_DEPT MARKETING STATEMENT:_** UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks **Research Scientists** to advance decision-grade evidence from real-world data to study and understand human health. H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data. H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.g., transcriptomics, proteomics, pathogen genomics). Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources. Researchers at H-COR collaborate across all five UTMB schools. **JOB DESCRIPTION:** Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB. Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care. Assures competence as a fully trained scientist in a specific discipline or area of expertise. **ESSENTIAL JOB FUNCTIONS:** + Leading and contributing to high-impact health and clinical outcomes research + Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets + Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNorm + Implementing modern causal-inference strategies (e.g., target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) + Collaborating across UTMB's schools on defined research programs + Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel + Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy + Presenting research at professional meetings and conferences + Participating in H-COR's monthly works-in-progress seminars **MINIMUM QUALIFICATIONS:** + Ph. D, M.D, D.O., or D.V.M in related field and one year of related experience. **PREFERRED QUALIFICATIONS:** + PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) + A track record in health and clinical outcomes methods + Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics + Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) + Fluency in at least two of R, Python, SAS, and SQL + Excellent scientific writing and communication + Evidence of peer-reviewed publications commensurate with career stage + Experience with OMOP and HL7 FHIR data models + Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods + Clinically oriented NLP and time-aware feature extraction + Familiarity with multi-omics data structures and cautious EHR-omics linkage + Experience in HPC or cloud settings (e.g., TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility + Mentorship of analysts or trainees + A record of effective, cross-disciplinary collaboration in an academic health-sciences environment **SALARY:** Commensurate with experience. **EQUAL EMPLOYMENT OPPORTUNITY:** UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Compensation

**Galveston, Texas, United States** Research Academic & Clinical UTMB Health Requisition # 2506239 **_DEPT MARKETING STATEMENT:_** UTMB's new Center for Health and Clinical Outcomes Research (H-COR) seeks **Research Scientists** to advance decision-grade evidence from real-world data to study and understand human health. H-COR leverages Epic EHR (Clarity/Caboodle and Cosmos), TriNetX, Medicare and other administrative data. H-COR has an interest in pairing outcomes research with secure, principled integration of high-dimensional modalities (e.g., transcriptomics, proteomics, pathogen genomics). Also of interest is the utilization of novel data sources including those derived from social media, mobile phones, wearables, and other digital sources. Researchers at H-COR collaborate across all five UTMB schools **JOB DESCRIPTION:** Conducts innovative scientific investigation by developing theories and devising scientific methods and procedures to apply scientific principles, theories and research in projects related to the mission of UTMB. Committed to the discovery of new innovative biomedical and health services knowledge leading to increasingly effective and accessible health care. Assures competence as a fully trained scientist in a specific discipline or area of expertise. **ESSENTIAL JOB FUNCTIONS:** + Leading and contributing to high-impact health and clinical outcomes research + Planning and performing advanced data analyses using UTMB's exceptional data infrastructure, with particular emphasis on electronic health record (EHR) data including EPIC, EPIC Cosmos, TriNetX, and Medicare administrative datasets + Building transparent cohort definitions and phenotypes using ICD-10/PCS, CPT/HCPCS, LOINC, and RxNorm + Implementing modern causal-inference strategies (e.g., target-trial emulation, robust confounding control, time-to-event and longitudinal models, principled handling of missingness, falsification and sensitivity analyses) + Collaborating across UTMB's schools on defined research programs + Contributing to abstracts, manuscripts, and grant applications as PI/Co-I or key personnel + Integrating clinical timelines with multi-omics and other high-dimensional data while preserving clinical interpretability and privacy + Presenting research at professional meetings and conferences + Participating in H-COR's monthly works-in-progress seminars **MINIMUM QUALIFICATIONS:** Ph. D, M.D, D.O., or D.V.M in related field and one year of related experience. **PREFERRED QUALIFICATIONS:** + PhD or equivalent doctoral degree in a relevant discipline (health services research, epidemiology, biostatistics, data science, computer science, or a closely related field) + A track record in health and clinical outcomes methods + Demonstrated expertise analyzing clinical and population-health data with specific experience in EHR analytics + Proficiency with large healthcare databases (Epic, Epic Cosmos, TriNetX, Medicare) + Fluency in at least two of R, Python, SAS, and SQL + Excellent scientific writing and communication + Evidence of peer-reviewed publications commensurate with career stage + Experience with OMOP and HL7 FHIR data models + Hands-on practice with target-trial emulation and advanced propensity and longitudinal methods + Clinically oriented NLP and time-aware feature extraction + Familiarity with multi-omics data structures and cautious EHR-omics linkage + Experience in HPC or cloud settings (e.g., TACC, Azure, AWS) and workflow engines that promote end-to-end reproducibility + Mentorship of analysts or trainees + A record of effective, cross-disciplinary collaboration in an academic health-sciences environment **SALARY:** Commensurate with experience. **EQUAL EMPLOYMENT OPPORTUNITY:** UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Compensation

The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote

Minimum Qualifications\: Bachelor's degree and five years experience as clinical research coordinator or equivalent experience. Preferred Previous clinical research experience The Senior Clinical Research Coordinator manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to insure compliance with regulations. Job Duties: Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities. Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor. Attends and participates in the Investigator meeting. Reviews goals and requirements of any new protocols and coordinates study initiation. Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals. Assesses staffing needs based upon current research activity and implements changes in staffing as needed Participates in protocol initiation visits Plans and designs source documentation for protocol Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice. Develops procedures for laboratory collection and storage. Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations. Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy. Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor. Precepts new clinical research staff and educates research staff regarding scientific aspects of studies. Provides performance management for staff under direction of PI. Assesses communication process within Department and/or services required by the protocol. Elicits relevant data from sources outside of the hospital. Assists PI in budget development; may monitor ledgers. Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards. Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment. Monitors participants labs and notifies the PI of laboratory findings. Serves as a role model and resource for the clinical research staff. May assist PI in obtaining Informed Consent from study participant and documents appropriately. Adheres to internal controls established for department. Salary Range: Actual salary commensurate with experience or range if discussed and approved by hiring authority. EQUAL EMPLOYMENT OPPORTUNITY: UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

**Galveston, Texas, United States** Clerical & Administrative Support UTMB Health Requisition # 2507038 **Minimum Qualifications:** Bachelor's degree and five years experience as clinical research coordinator or equivalent experience. **Preferred** Previous clinical research experience **Job Summary:** The Senior Clinical Research Coordinator manages clinical research projects for Principal Investigators by gathering patient data via methods specified in the study protocol. Provides complex administrative duties in support of the study to insure compliance with regulations. **Job Duties:** + Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities. + Under the direction of the PI, supervises and assists with the preparation and submission of all IRB and Regulatory Documents to obtain final approval and may draft various communications with Sponsor. + Attends and participates in the Investigator meeting. + Reviews goals and requirements of any new protocols and coordinates study initiation. + Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals. + Assesses staffing needs based upon current research activity and implements changes in staffing as needed + Participates in protocol initiation visits + Plans and designs source documentation for protocol + Develops assessment tool per protocol to use in clinical research and teaches research team and hospital personnel how to use the assessment tool as allowed per medical practice. + Develops procedures for laboratory collection and storage. + Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations. + Maintains accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, reconciling study drug accountability; monitors documentation for quality and accuracy. + Conducts reviews of on-going studies and oversees quality assurance on ongoing protocols; productive working relationship with the study monitor. + Precepts new clinical research staff and educates research staff regarding scientific aspects of studies. + Provides performance management for staff under direction of PI. + Assesses communication process within Department and/or services required by the protocol. + Elicits relevant data from sources outside of the hospital. + Assists PI in budget development; may monitor ledgers. + Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; ensures return of test article /clinical supplies; maintains regulatory standards. + Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary; mentors all clinical research personnel regarding enrollment/recruitment. + Monitors participants labs and notifies the PI of laboratory findings. + Serves as a role model and resource for the clinical research staff. + May assist PI in obtaining Informed Consent from study participant and documents appropriately. Adheres to internal controls established for department. **Salary Range:** Actual salary commensurate with experience or range if discussed and approved by hiring authority. **EQUAL EMPLOYMENT OPPORTUNITY:** UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities. Compensation

Job Description Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

Postdoctoral Research Scientist & Clinical Psychologist - PTSD & Addiction Research Location: Rockville, MD | Full-Time Join a dynamic team advancing evidence-based treatment for addiction and PTSD. Maryland Treatment Centers (MTC) is seeking a full-time Research Scientist and Clinical Psychologist to support innovative addiction research within our Rockville treatment center. This role offers the chance to develop a research-oriented career in substance use disorder (SUD) and trauma treatment while working alongside a multidisciplinary clinical team. What You'll Do: · Coordinate a clinical trial for the treatment of PTSD taking place within a residential addiction treatment setting. · Provide direct clinical services (Written Exposure Therapy for PTSD) as a study therapist on the project. · Supervise research staff and assist with data collection and analysis. · Collaborate with senior researchers on publications, grant development, and new studies. · Mentor trainees and participate in extern supervision and teaching. Why Join Us: · Be part of a robust research division housed within a community treatment program · Work in a supportive, collaborative, and mission-driven environment. · Receive mentorship, professional development, and travel support for research dissemination. · Grow into leadership roles in clinical research or program development. What We're Looking For: · PhD or PsyD in Clinical Psychology (or related field). · Licensed or license-eligible in Maryland (supervision possible). · Interest or experience in addiction and trauma research preferred. · Masters-level clinicians with research curiosity encouraged to apply (e.g., LCPC, LCSW).

SUMMARY/JOB PURPOSE: The Senior Clinical Trials Specialist, Clinical Operations, role coordinates the activities associated with the evaluation, initiation, and management of oncology clinical trials. This role provides operational support to the Study Delivery Lead (SDL) by managing assigned study activities and clinical sites, providing CRO oversight, and maintaining accurate study documentation. ESSENTIAL DUTIES AND RESPONSIBILITIES: * Review study documents to manage oncology clinical trials, determine operational risks, and develop mitigation plans to address risks proactively * Responsible for clinical sites within assigned geographical region, and assist with managing/overseeing external vendors within a specific scope (e.g., Lab), as assigned by SDL * Provide CRO oversight on activities related to site start-up and maintenance, including reviewing trip reports, protocol deviations, data review, etc. * Participate in meetings with CROs and cross-functional study teams to proactively work to mitigate project risks and resolve issues * Assist with review and development of study documents and plans (e.g. Protocol, Informed Consent Form (ICF), Vendor Oversight Plan, eCRF Guidelines, Data Review Plan, Safety Management Plan, Pharmacy Manual, IRT specifications, User Manuals) * Review compound-specific ICF and develop study-specific ICF templates * Assist Study Delivery Team (SDT) and CRO in feasibility assessments and site selection * Responsible for study start-up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, and regulatory documents * Assist with protocol and study-specific training with vendor(s), site personnel and clinical sites * May coordinate the preparation, conduct, and presentations at Investigator Meetings * Review monitoring visit reports for completeness, accuracy, and adherence to the protocol * Coordinate clinical drug/supply reconciliation with oversight of CRO and site reconciliation * May conduct UAT for EDC / IRT and data listing review of EDC data for analysis * Compile and review appendices for preparation of clinical study reports * Review and/or create study documents (e.g. newsletters, and various study / site trackers) * Assist in the coordination of Study Delivery Team (SDT) meetings, prepare agenda, draft and finalize minutes, and track action items to completion * Maintain internal document management system and submit to TMF ensuring Regulatory and Essential/Important documents, and communication are filed timely and appropriately * May assist in materials preparation for strategic governance discussions as required SUPERVISORY RESPONSIBILITIES: * None EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience: * BS/BA/BSN in biological sciences or related field and a minimum of 5 years of related experience; or, * MS/MA/MSN in biological sciences or related field and a minimum of 3 years of related experience; or, * Equivalent combination of education and experience. Experience/The Ideal for Successful Entry into Job: * Typically requires a minimum of 5 years of related experience in life sciences, including 3 years in experience in clinical research Knowledge/Skills: * Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation * Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study-specific procedures * Experience with development of prospective site-selection criteria * Familiar with medical terminology, and basic concepts of clinical research * Ability to deal with time demands, incomplete information or unexpected events * Experience in interactions with outside vendors, e.g., CROs and contract labs * Demonstrated ability to write and present clearly using on scientific and clinical issues terminology * Applies technical standards, principles, theories, concepts and techniques * Advanced computer skills * Good organizational and planning skills * Strong interpersonal skills and communication skills (both written and oral) * Ability to work effectively in a team/matrix environment * Ability to understand technical, scientific and medical information * Demonstrated success in problem-solving * Self-motivation, eagerness to grow professionally and commitment to self-development JOB COMPLEXITY: * Works on assigned problems of moderate scope with analysis of situation or data required. * Exercises judgment within defined procedures and practices to determine appropriate action. * Builds productive internal and external working relationships. * Uses professional concepts and company policies and procedures to solve a variety of routine problems. * Demonstrated professional collaboration skills * Capable of identifying task-related challenges and prioritizing activity accordingly DESIRED BEHAVIORS: * Resilient in the context of a rapidly changing environment * Organized with a systematic approach to prioritization * Works independently to meet objectives and completes tasks within established timelines. * Expresses curiosity, asks questions and shares perspective, appropriately EXHIBITS EXELIXIS LEADERSHIP COMMITMENTS: * We drive for results, so patients can survive and thrive. * We are resilient in the face of adversity, and tireless in advancing our science. * We celebrate our long history of prolific drug discovery and rigorous drug development. * We unite to launch innovative medicines for difficult-to-treat cancers. * We exist to give people hope - one drug, one patient at a time. * We are Exelixis. LIVES THE EXELIXIS CORE VALUES DAILY: * Be Exceptional (Take the right action and lead others to do the right thing at the right time in the right way), * Exceed Together (Apply rigor, resourcefulness, and respect to maximize opportunities and deliver impactful results) * Excel for Patients (Innovate to design solutions and remove barriers to show how much we care) WORKING CONDITIONS: * Travel may be required up to 20% in support of clinical study activities #LI-JD1 If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $108,500 - $153,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors. In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year. DISCLAIMER The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Job Description The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.

The Assistant Clinical Research Coordinator comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal regulations. Some responsibilities of the Clinical Research Coordinator include: 1. Preparing for study initiation 2. Obtaining physician signatures 3. Recruiting subjects 4. Screening and scheduling subjects 5. Getting voluntary subject consent 6. Teaching subjects about protocol expectations for them 7. Performing study/protocol procedures in a detailed, accurate manner 8. Maintaining study files 9. Tracking subjects, avoiding lost-to-follow-up 10. Documenting an adverse event 11. Processing and shipping lab work 12. Maintaining communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel 13. Completing case report forms (CRF's) for PI review and approval 14. Helping study monitors with CRA corrections 15. Maintaining study-specific supplies 16. Preparing for study closure and archiving Knowledge of Spanish and / or Phlebotomy Training will be an added advantage.

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Superior Street Job Description The Clinical Research Coordinator II coordinates all clinical research activities with moderate supervision. Adheres to the service values and principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. In this role, you collect biospecimens such as nasal swabs, buccal swabs, and stool samples from research participants. You are then responsible for ensuring the proper processing, storage, and shipping of those samples. Essential Job Functions: Coordinates and manages the initiation and regulatory compliance of clinical research studies, including preparing all necessary documents for IRB and sponsor review, coordinating study conduct across departments, and securing required approvals. Manages study documents, including regulatory binders, source documents, and correspondence, while maintaining adherence and compliance to research protocols. Coordinates and oversees all aspects of clinical research visits, including arranging and conducting visits, conducting site qualifications, initiation, monitoring, and close-out visits. Collects specimens from subjects and ensures proper processing, records data on source documents and electronic systems, and conducts literature searches while assisting with QA/QC procedures to ensure data accuracy and protocol compliance. Manages participant engagement throughout clinical trials by identifying eligible subjects, conducting informed consent processes, coordinating reimbursement, verifying eligibility, and serving as the primary patient liaison for study-related inquiries and support. Manages and oversees all aspects related to supplies and equipment inventory, including preparation of lab kits and requisitions. Tracks and manages deadlines for grants and deliverables. Prepares abstracted and coded data for subsequent processing and analysis, while also developing codebooks for data dictionaries to ensure comprehensive data organization and accessibility. Participates actively in investigator meetings, contributing to the ethical conduct of research through educational initiatives, and represents research findings at meetings and conferences. Assists with financial aspects of studies including invoicing and billing management. Other job functions as assigned. Knowledge, Skills, and Abilities: Bachelor's degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. Proficient knowledge of FDA, HSR, and GCP Guidelines. Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. Proficient entry level leadership skills. Recognizes the need to prioritize tasks, problem solve, and work with others. Assists to foster an inclusive environment where all team members feel valued and respected. Education Bachelor's Degree (Required) Pay Range $49,920.00-$81,619.20 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location 875 N Michigan (John Hancock) Job Description Assists investigators and study team in the implementation, coordination, and conduct of clinical research activities. Adheres to the service values and principles as well as the principles of research ethics. Under direct supervision, the balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsors and regulatory agencies (i.e. regulatory binders, source documents, correspondence, etc). Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary study documents for IRB and/or sponsor review. Assists clinical research personnel in the implementation of clinical research projects, assists in the identification and recruitment of eligible study subjects. Maintains inventory of study supplies and equipment. Prepares lab kits and requisitions prior to visits. Collects specimens from subjects and processes specimens as instructed. Helps arrange study visits and provide instructions to study participants and families. Coordinates reimbursement for study subjects. Helps triage patient questions. Assists with adverse event monitoring and reporting. Assists in creating and maintaining case report forms or source document templates. Abstracts data from medical records and enters information into study-specific forms and electronic data capture platforms. Facilitates study initiation, monitoring and close-out visits. May attend investigator meetings. Supports research activities by conducting literature searches, assisting with QA/AC procedures, entering, coding, creating, updating data spreadsheets, retrieving, preparing, and managing data through importing and exporting in various formats. Other job functions as assigned. Knowledge, Skills and Abilities: Bachelor's degree required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. Good organizational skills. Good verbal and written communications skills. Some knowledge of FDA, HSR, and GCP Guidelines. Proficient analytical skills with the ability to remain agile and adaptable to various technological systems. Education Bachelor's Degree (Required) Pay Range $46,280.00-$75,670.40 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: Supplemental Life, AD&D and Disability Critical Illness, Accident and Hospital Indemnity coverage Tuition assistance Student loan servicing and support Adoption benefits Backup Childcare and Eldercare Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members Discount on services at Lurie Children's facilities Discount purchasing program There's a Place for You with Us At Lurie Children's we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints - recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Collects data for clinical trials research, following general directions. Supports the preparation of study documentation for submission to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports), with limited guidance. Assists with the development and/or implementation of standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions, under guidance. Learns about providing input on implementing budgeting components for internally funded standard projects. Learns to draft and submit clinical trials applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures. Essential Responsibilities: * Pursues effective relationships with others by sharing resources, information, and knowledge with coworkers and members. Listens to, addresses, and seeks performance feedback. Pursues self-development; acknowledges strengths and weaknesses based on career goals and takes appropriate development action to leverage / improve them. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work. Assesses and responds to the needs of others to support a business outcome. * Completes work assignments by applying up-to-date knowledge in subject area to meet deadlines; follows procedures and policies, and applies data and resources to support projects or initiatives with limited guidance and/or sponsorship. Collaborates with others to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports the completion of priorities, deadlines, and expectations. Identifies and speaks up for ways to address improvement opportunities. * Assists in budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard projects. * Conducts clinical research by: collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments) following general directions; leveraging a working knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; developing a working knowledge of clinical trials, studies, and interventions at the site-level; contributing to the development of standard clinical research protocols and other processes of clinical trials with limited guidance; supporting the preparation of study documentation sent to regulatory bodies (e.g., IRB) for review and approval prior to implementation, under guidance; may also be responsible for supporting or executing standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens), with guidance. * Supports research compliance by: learning to draft and submit clinical trial applications, under guidance, in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures; assisting with the identification of compliance and/or quality issues, escalating as necessary; implementing updates to compliance-monitoring/audit systems and documentation with guidance; learning to and performing data entry tasks with minimal supervision to assist with risk-management; implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data with minimal supervision; and leveraging basic research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines. * Learns to maintain internal and external effective working relationships by: leveraging a working knowledge of how to support important research stakeholders and projects within their unit; communicating, under minimal guidance, with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on standard protocols, documentation procedures, clinical best practices, or timeliness of submissions under guidance. * Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) with general directions and limited guidance; assisting with the development of standard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a working knowledge of how to monitor and audit Clinical Trials as well as documenting findings.