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.
This position assists Clinical Research Coordinators (CRCs), investigators, and study teams with participant scheduling, specimen processing, investigational product accountability support, supply management, and study-related documentation. The Clinical Research Assistant plays a critical role in ensuring efficient study conduct while allowing coordinators to focus on protocol management, participant care, and study execution.
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.
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.
p>• 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.
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.
In addition, the CRC III – Team Lead supports regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources. Regulatory and Quality SupportSupport regulatory and quality functions directly with the team and in collaboration with centralized regulatory and quality resources.
With 15 schools, colleges, and institutes-including Business, Law, Medicine, Nursing, and Health Sciences-Loyola operates three primary campuses in the greater Chicago area and one in Rome, Italy, that provide students a transformative, globally connected learning experience. No Job Category University Staff Job Type Full-Time FLSA Status Non-Exempt Campus Maywood-Health Sciences Campus Department Name RADIATION ONCOLOGY Location Code RADIATION ONCOLOGY (06720A) Is this split and/or fully grant funded?
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.
p>What You'll Do:
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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.
As we provide comprehensive services at our state-of-the-art inpatient and outpatient facilities, we remain driven by our basic oath to help patients heal while providing a genuine, human touch. WE ARE INSIGHT: Envisioning and implementing a holistic approach to neurological treatment is our goal, and our unique research and powerful solutions illuminate the path toward greater innovations for the future of healthcare.
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.
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.
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.
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.
li>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.
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.
Additional Qualifications: Expert database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. We are seeking a full-time Clinical Research Coordinator with a minimum of 1 year of clinical experience, for our Additionally, someone with a strong interest in the Clinical Research field would be an excellent fit for our entry level position, with room to grow.
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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.
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.
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. As an integrated health system, we deliver exceptional, coordinated across seven hospitals, 85 primary and specialty clinics, and a team of over 7,500 professionals serving northern Illinois and southern Wisconsin.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Act as liaison between physicians, clinical staff and the UIC IRB office, grant sponsors and regulatory agencies to ensure priorities are clearly communicated and resources are allocated appropriately across multiple ongoing projects. Position Summary The CCTS Senior Clinical Research Coordinator is responsible for managing, coordinating and implementing all components of clinical research protocols, including pre and post research activities, internal and external to the clinical setting.
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.
Additional Qualifications: Database and computer skills: Microsoft Office (Word, Excel), Outlook, excellent verbal and written communication skills, ability to work independently and assume responsibility, excellent organizational skills, ability to meet data deadlines and maintain confidentiality. Education/ Training: International Medical Graduate; MBBS, BMBS, MBChC, MBBCh, MD, DO, MCM, DM, MCM, MMSc, MMedSc, MM, MMed, MS, MSurg, MChir, MCh, ChM, CM, MSc, DCM, DClinSurg, DMSc, DMedSc, DS, DSurg.
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.
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.
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.