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.
div> Our Mission: Improving Lives by Providing Advanced Therapeutic Options Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research Our Values:
p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. The role offers a weekly workload of 40-50 hours, varying by study phase, with opportunities for hybrid work arrangements to support work-life balance.
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.
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.
We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Exemplifies the Rush mission, vision and values and acts in accordance with Rush policies and procedures.\n \nOther information:\n \nRequired Job Qualifications:\n\n Education: Bachelor of Science in Nursing (BSN) OR Master of Science in Nursing (MSN)\n Experience: Two years of clinical nursing practice experience required\n Licenses: Current State of Illinois Registered Nurse Licensure\n Certifications: Current Basic Life Support certification for Healthcare Professionals\n \nKnowledge, Skills, and Abilities:\n\n Regulatory Compliance Awareness \u2013 Able to demonstrate introductory knowledge of Good Clinical Practices and/or Good Documentation Practices, human subjects protections, institutional, local, state and federal guidelines and regulations related to clinical research\n Communication Skills \u2013 Ability to communicate complex clinical and regulatory concepts in easy-to-understand language.\n \n Certifications: Clinical specialty certification appropriate to study population\n \nPhysical Demands:\n \nCompetencies:\n \nDisclaimer: The above is intended to describe the general content of and requirements for the performance of this job It is not to be construed as an exhaustive statement of duties, responsibilities or requirements\n \nResponsibilities:\n \nJJob Responsibilities:\n \nRelationships and Caring\n\n Delivers protocol-required nursing care to research participants, including monitoring of health status and documentation \n Follows participant care plans based on protocol requirements and participant needs\n Assesses participant status and communicates follow-up needs to the PI or interdisciplinary care team in alignment with protocol \n Communicates study details and updates to participants, families, and interdisciplinary care team members\n Educates interdisciplinary care teams on protocol requirements \n Notifies the PI and care team of changes in participant health status.\n
li> Willing and able to travel up to 50% for on-site monitoring visits across southeast region; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel. Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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.
li> Willing and able to travel up to 50% for on-site monitoring visits across Midwest region; preference given to candidates residing in Chicago near major HUB airports to support efficient regional travel. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
li> Willing and able to travel up to 60% for on-site monitoring visits across the Midwest region; preference given to candidates residing in Midwest region near major HUB airports to support efficient regional travel. ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
div> Overview: The primary function of the Clinical Research Coordinator (CRC) is to coordinate the conduct of clinical research studies in a clinic/hospital setting with an emphasis on the screening, enrollment, and monitoring of research patients. Click here for more details regarding Mercyhealth Careers Benefit Information.
Review and synthesize information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract industry, cooperative, and investigator-initiated trial data as specified by research protocol. Collaborate with clinical and regulatory coordinators to document and report study patient enrollment, treatment, and follow-up into sponsor's database, including protocol adherence, adverse events, and treatment outcomes.
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>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.).
Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments. Our CRC I's will partner with tenured Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators.
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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.
The Healthy Aging & Alzheimer''s Research Care (HAARC) Center is a multidisciplinary center at the University of Chicago focused on implementing research on aging, Alzheimers, and related dementia research focused on optimizing knowledge, care, interventions, and quality of life. This role will involve indirect care through research protocols, research clinical assessments, and participation in clinical research studies aimed at improving diagnosis, treatment, and management of neurodegenerative diseases.
In addition to CRC1, the position will also serve as a Dental Assistant (DA1) at The University of Chicago Medicine (UCM) Dental Research Study Clinic and will be responsible for chairside assisting to dental providers providing dental care to patients at the University of Chicago Medicine (UCM) Dental Research Study Clinic at its main campus in Hyde Park as well as other study sites, including mobile dental units. The Clinical Research Coordinator I - Oral Health Research Staff (CRCI) is an entry level researcher working with the Principal Investigator (PI) Dr. David Meltzer, Co-Investigator(s) and other study personnel, to support and provide guidance on the administration of the compliance, financial and other related aspects of the clinical study.
li>Unique or Preferred Skills: Strong finance, accounting and reporting/analytics skills; Strong skills in the use of database and spreadsheet applications; Experience with Workday Finance or Workday Grants or other similar ERP application; Knowledge of NIH Grants Policy Statements, OMB Circular A-133, DHHS Policy, PCROI Policy; Strong written and oral communication skills; Microsoft Office Suite of applications; Online sponsor submission systems like NIH ASSIST, DOD EeBrap, Grants. Our more than 25,000 team members and more than 6,000 physicians aim to deliver transformative patient experiences and expert care close to home across more than 300 ambulatory locations and eight acute care hospitals – Edward (Naperville), Elmhurst, Evanston, Glenbrook (Glenview), Highland Park, Northwest Community (Arlington Heights) Skokie and Swedish (Chicago) – all recognized as Magnet hospitals for nursing excellence.
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Maintains research files, designs forms as needed, reports findings as appropriate, assists in preparation or review of material for submission to an IRB including reviewing and editing protocols and consent documents, where applicable. Attends investigator's meetings, coordinates and attends pre-study site visits, study initiation visits, and all other study-related visits by Monitors or Sponsor representatives, when required.
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