Chicago, Illinois11 days ago
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Chicago, Illinois18 days ago
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The Manager, Clinical Research role provides leadership, strategic management, and administration for clinical and translational research. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.
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Job Description.
General Summary: .
p>The Lead Clinical Research Data Manager will perform a variety of data management duties of a complex and technical nature in support of clinical research studies conducted by principal investigators (PIs) for the clinical research program to ensure adherence to protocols and quality of information received. Technical Skills or Knowledge: Advanced data management skills, including oversight of database design, complex data integration across multiple sources, identification of discrepancies, and implementation of quality control measures to support clinical research.
Operating within a matrixed academic medical center environment, this role partners closely with senior academic and hospital leadership, faculty investigators, and multidisciplinary technical teams to ensure clinical data are transformed into trusted, interoperable, and AI-ready research assets. This role is intentionally designed as a hybrid management position: the Manager is accountable for strategy, architecture, prioritization, team leadership, and optimization of technical solutions, while generally guiding and overseeing implementation rather than serving as the primary individual contributor.
Works with the Research Business Operations (RBO) offices and Office of Clinical and Community Trials (OCCT) to facilitate contract negotiations and execution, to ensure proper accrual tracking, and to provide additional information as needed for timely financial reconciliation, management, and reporting. 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.
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The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to 1) analyze and interpret applicable regulations, 2) develop/revise institutional policies and procedures, 3) audit the conduct of human subjects research (biomedical, social & behavioral) and research oversight programs, 4) assess compliance with all applicable regulations, guidances, and policies and procedures, 5) identify areas of risk, and 6) oversee the development and implementation of corrective and preventive action plans. Lurie Children's Hospital of Chicago
Job Description.
By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. • Lead patient recruitment activities, e.g., performing chart reviews, discussing protocols with patients, and verifying the informed consent documentation to meet enrollment targets on assigned studies.
li> Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
Typically involved in all stages of the clinical study, including identifying potential sites to participate in the research effort, performing various study start-up activities such as working with sites to collect appropriate regulatory documents and supporting the negotiation of contracts and budgets, training the sites to collect data properly and report any potential safety-related events, managing the site's activities during study maintenance, and closing down research activities at the sites once the study has concluded. As a Clinical Research Associate (CRA) at Worldwide, you will find yourself working alongside brilliant minds across diverse therapeutic areas, including Cardiovascular, Metabolic, Neuroscience, Oncology, and Rare Diseases.
p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. As a Clinical Research Assistant, PRN (Registered Nurse), you'll play a key role in delivering life-changing research opportunities to participants but with the flexibility to work when and where it fits your life.
li> Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits. The Office of Clinical Research, through the Clinical Research Incubation Unit, provides research conduct, data management, and regulatory services to departments, sections, and units who are building their research portfolio or who need bridge support during a high growth period or during periods of staffing transitions.
p>With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. As a Clinical Research Assistant, PRN (Registered Nurse), you'll play a key role in delivering life-changing research opportunities to participants but with the flexibility to work when and where it fits your life.
p>Location: Chicago, Illinois\n \nBusiness Unit: Rush Medical Center\n \nHospital: Rush University Medical Center\n \nDepartment: Neurological Sciences-Res Adm\n \nWork Type: Full Time (Total FTE between 0.9 and 1.0)\n \nShift: Shift 1\n \nWork Schedule: 8 Hr (7:00:00 AM - 4:30:00 PM)\n \nRush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).\n \nPay Range: $23.12 - $32.66 per hour\n \nRush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.\n \nRequired Job Qualifications:\n \nEducation:\n\n Bachelor's degree \n \nExperience: \n\n 0-2 years of experience in a research study or other relevant experience\n \nOR\n \nExperience (in lieu of a degree)\n\n Two (2) years' total experience, where 1 year is supporting or coordinating research studies\n \nKnowledge, Skills, & Abilities:\n\n Time Management \u2013 Ability to meet deadlines and manage assigned study tasks.\n
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart.
p>The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to 1) analyze and interpret applicable regulations, 2) develop/revise institutional policies and procedures, 3) audit the conduct of human subjects research (biomedical, social & behavioral) and research oversight programs, 4) assess compliance with all applicable regulations, guidances, and policies and procedures, 5) identify areas of risk, and 6) oversee the development and implementation of corrective and preventive action plans. Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM&R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).
p>The Office of Clinical Research (OCR) is dedicated to supporting the infrastructure for the management and administration of clinical research at The University of Chicago as well as individual research programs with the goal of improving communication, consistency and collaboration across the Biological Sciences Division and UChicago Medicine. The mission of the OCR is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers.
Oversees day-to-day operations including identifying & securing needed resources; creating, implementing, monitoring, & updating project plans; facilitating meetings with appropriate parties; tracking tasks/deliverables to ensure timelines, milestones &/or goals are attained; monitoring & reporting progress as appropriate; & resolving or escalating issues in a timely manner. Collaborating with nursing staff and Principal Investigator (PI) ascertains pretreatment & eligibility requirements; interviews participants & obtains social & medical histories; based on results determines & registers participants with appropriate sponsors; completes informed consent; determines & organizes patients treatment and test schedules.
p>Requirement : • Bachelors and/or a combination of related experience • 8+ years' experience • Able to handle a variety of clinical research tasks • Excellent organizational and communication skills • Professional use of the English language; both written and oral • Experience in utilizing various clinical database management systems • Broad knowledge of drug, device and/or biologic development and effective data management practices • Strong representational skills, ability to communicate effectively orally and in writing • Strong leadership and interpersonal skills • Systems knowledge with Medidata Rave and Veeva • Ability to undertake occasional travel. • Develop CRF specifications from the clinical study protocol and coordinate the review/feedback from all stakeholders • May assist in building clinical databases • Conduct database build UAT and maintain quality controlled database build documentation.
This role works closely with investigators, research associates, or project managers to ensure that studies run smoothly, data remains accurate and organized, and participants receive clear communication and support throughout their involvement in clinical research trials. The Research Coordinator supports clinical research studies by carrying out day-to-day operational tasks related to participant recruitment, data collection, data management, and reporting.
The Section provides extremely valuable collaborations with investigators in the Department of Medicine who are seeking to develop new and more powerful ways to identify genetic risk factors for common, complex disorders with almost immediate clinical application. Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
These research trials (both established and future) will include multi-centered cooperative group and intergroup trials at a national level, multi-institutional pharmaceutical trials, device trials, and single and multi-centered trials, designed, implemented, and coordinated in the Section. This position will play a central role in the conduct of investigator-initiated and industry-sponsored clinical trials across the cardiovascular service line, including (but not limited to) heart failure, interventional cardiology, electrophysiology, pulmonary hypertension, and device-based therapies.
p>The mission of the Office of Clinical Research is to catalyze clinical research by providing expertise, resources, infrastructure, and systems that facilitate clinical research operations and enable collaboration across the enterprise while promoting compliance and human subject protection on behalf of our diverse community of patients and volunteers. The Office of Clinical Research (OCR) is the nucleus of the clinical research enterprise, providing services, training, tools and compliance oversight to support the conduct of clinical research across the entire Biological Sciences Division and University of Chicago Medicine human subject research portfolio.
Location: Chicago, Illinois\n \nBusiness Unit: Rush Medical Center\n \nHospital: Rush University Medical Center\n \nDepartment: Road Home Research Admin\n \nWork Type: Full Time (Total FTE between 0.9 and 1.0)\n \nShift: Shift 1\n \nWork Schedule: 8 Hr (7:00:00 AM - 3:00:00 PM)\n \nRush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).\n \nPay Range: $23.12 - $32.66 per hour\n \nRush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.\n \nRequired Job Qualifications:\n \nEducation:\n\n Bachelor's degree \n \nExperience: \n\n 0-2 years of experience in a research study or other relevant experience\n \nOR\n \nExperience (in lieu of a degree)\n\n Two (2) years' total experience, where 1 year is supporting or coordinating research studies\n \nKnowledge, Skills, & Abilities:\n\n Time Management \u2013 Ability to meet deadlines and manage assigned study tasks.\n
p>Location: Chicago, Illinois\n \nBusiness Unit: Rush Medical Center\n \nHospital: Rush University Medical Center\n \nDepartment: Anesthesia Support\n \nWork Type: Full Time (Total FTE between 0.9 and 1.0)\n \nShift: Shift 1\n \nWork Schedule: 8 Hr (8:00:00 AM - 4:30:00 PM)\n \nRush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).\n \nPay Range: $23.12 - $32.66 per hour\n \nRush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.\n \nRequired Job Qualifications:\n \nEducation:\n\n Bachelor's degree \n \nExperience: \n\n 0-2 years of experience in a research study or other relevant experience\n \nOR\n \nExperience (in lieu of a degree)\n\n Two (2) years' total experience, where 1 year is supporting or coordinating research studies\n \nKnowledge, Skills, & Abilities:\n\n Time Management \u2013 Ability to meet deadlines and manage assigned study tasks.\n
Location: Chicago, Illinois\n \nBusiness Unit: Rush Medical Center\n \nHospital: Rush University Medical Center\n \nDepartment: Int Med Cardiology-Res Fac\n \nWork Type: Full Time (Total FTE between 0.9 and 1.0)\n \nShift: Shift 1\n \nWork Schedule: 8 Hr (8:30:00 AM - 5:00:00 PM)\n \nRush offers exceptional rewards and benefits learn more at our Rush benefits page (https://www.rush.edu/rush-careers/employee-benefits).\n \nPay Range: $23.12 - $32.66 per hour\n \nRush salaries are determined by many factors including, but not limited to, education, job-related experience and skills, as well as internal equity and industry specific market data. Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.\n \nRequired Job Qualifications:\n \nEducation:\n\n Bachelor's degree \n \nExperience: \n\n 0-2 years of experience in a research study or other relevant experience\n \nOR\n \nExperience (in lieu of a degree)\n\n Two (2) years' total experience, where 1 year is supporting or coordinating research studies\n \nKnowledge, Skills, & Abilities:\n\n Time Management \u2013 Ability to meet deadlines and manage assigned study tasks.\n
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General Summary:. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.
Lurie Children's Hospital of Chicago Job Description. Coordinates all clinical research activities with moderate supervision.
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Job Description.
Coordinates all clinical research activities with moderate supervision.
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Coordinates all clinical research activities with moderate supervision. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.
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What Youll Do: Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the.
p>We offer a competitive compensation plan and benefits package including medical/dental/vision/life insurance as well as a matching retirement contribution, tuition reimbursement, bonus program, pension plan, paid vacation/medical/personal days, work-life balance, recognition program and casual work environment. A sister organization to the Academy, the American Academy of Dermatology Association is the resource for government affairs, health policy and practice information for dermatologists, and plays a major role in formulating policies that can enhance the quality of dermatologic care.
li>Lead the strategic review and interpretation of clinical investigative plans and payer policies, including Medicare, Medicare Advantage, Medicaid, and commercial payers, to establish comprehensive coverage and reimbursement strategies for IDE, PAS and PMS, Coverage with Evidence Development, and other sponsored trials across all therapy areas including Cardiac Rhythm Management, Electrophysiology, Heart Failure, Neuromodulation, Structural Heart, and Vascular.
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Job Description.
Assists investigators and study team in the implementation, coordination, and conduct of clinical research activities.
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General Summary: . For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits.
Lurie Children's Hospital of Chicago Job Description. Assists investigators and study team in the implementation, coordination, and conduct of clinical research activities.
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Job Description.
Assists investigators and study team in the implementation, coordination, and conduct of clinical research activities.
Senior Clinical Research Coordinators are responsible for recruiting and retaining participants; developing and implementing SOPs, workflows, and protocol training; allocating staff time and tasks; reviewing data for accuracy; and achieving recruitment and visit completion targets to ensure study objectives are met. The incumbent serves as the primary liaison for the project team, which may include physicians, nurses, project managers, lab technicians, and data staff; and communicates with internal and external hubs, sponsors, national groups and other external entities.
Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
Your previous roles/job titles may include Clinical Data Manager, Senior Clinical Data Manager, Lead Data Manager, Principal Data Manager, and/or Data Management Project Manager. IQVIA is seeking experienced Clinical Data Management Leads to oversee end-to-end data management delivery for global clinical trials.
The position implements and conducts of multiple research projects in the Clinical Research Center - coordinating comprehensive patient protocol treatment schedules to maintain compliance to protocol requirements, Developing and implementing effective patient recruitment strategies, and participating in subject recruitment, screening, scheduling, testing, and data management for a multi-faceted investigation. The Clinical Research Coordinator works within the CCTS Clinical Research Center and is responsible for managing and coordinating the timely handling of all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting.
Under the supervision of the Technical Director and facility manager of the cGMP Core, this position requires the candidate to collaborate within a team atmosphere that process and compound clinical grade vaccines and cell therapy products in the Cellular and Tissue Based Processing cGMP Facility. This registration complies with federal regulations that require clinical facilities engaged in production of cellular products follow strict guidelines to minimize microbial contamination and manufacture cellular-based products that are sterile and potent for their intended purpose.
p>Keywords: clinical research, oncology trials, monitoring, GCP, regulatory compliance, site management, clinical data review, adverse events, safety reporting, EDC systems, clinical operations, study start-up, protocol adherence, FDA regulations, ICH guidelines, data integrity, stakeholder communication, CRO, site visits, trial oversight. The Clinical Research Associate (CRA) will play a key role in overseeing oncology-focused studies across multiple sites, ensuring trial execution aligns with regulatory expectations and study requirements.
p>Keywords: Clinical Research Associate, CRA, Clinical Trials, Site Monitoring, EDC Systems, Oncology Research, GCP, ICH Guidelines, Study Start-Up, Remote Monitoring, On-site Monitoring, Clinical Operations, Protocol Compliance, Data Review, Regulatory Oversight, CRO, Clinical Development, Trial Management, Multi-site Studies, Investigator Relations, Monitoring Visits, Risk-Based Monitoring, Clinical Documentation, Pharma Research, Biotech Studies, Data Integrity, Study Activation, Research Compliance, Trial Oversight, Drug Development, Clinical Systems. The Oncology Clinical Research Associate will play a vital role in managing investigative sites and ensuring the successful delivery of clinical studies across a national footprint, with an emphasis on high-quality data and regulatory compliance.
p>The Clinical Research Nurse Coordinator is a registered professional nurse who demonstrates exemplary clinical research knowledge, has strong communication skills, and is responsible for serving as a liaison between Northwestern University (NU) clinical research investigator teams and Northwestern Medicine; a joint collaboration between NMG and the NU Feinberg School of Medicine.
p>Duties and Responsibilities Planning and implementation clinical trial to include but not limited to: • Coordination with all members departments external institutions of the study team • Oversight of IRB regulatory and/or FDA submissions • Budget preparation • Participation and study management • Tool development • Provide education and training to other health care professionals related to patient participation in a clinical trial • Screening, recruitment, and enrollment of study participants • Procure eligibility data and materials • Interface with sponsors, investigators as appropriate in determining eligibility • Oversee study lab specimen collection, processing, and shipping, and long-term data collection • Prepare and participate in Cooperative Group Audits • NCI FDA Sponsor GCP quality audits • Loyola internal audits and department audits • Participation in program research planning to include as appropriate: • Protocol development • Data reporting • Grant reporting • Participate in Departmental Process Improvement Activities • National Committees as appropriate • Collaborates with the PI in the case management of protocol patients, assuring patient safety and compliance with the protocol and regulatory requirements and patient billing compliance • Communicates with the appropriate clinical staff in coordination of patient care • Data management, collecting data entry of accurate data • Monitor and train clinical protocol coordinators in accurate and timely data collection • Provide oversight and guidance to clinical protocol coordinators regarding several research protocols • IRB submissions and regulatory management • Perform other duties as assigned. Minimum Education and/or Work Experience Minimum Education Required: Bachelors Degree OR equivalent training acquired via work experience or education Preferred Bachelors Degree Specify Degrees Nursing Minimum Experience Required: 1-2 years of previous job-related experience Preferred 3-5 years of previous job-related experience.
p>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 Childrens facilities • Discount purchasing program. 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.