Clinical Research Records Manager

4 weeks ago


North Chicago, Illinois, United States AbbVie Full time
Job Description

Purpose: We are seeking a highly skilled Clinical Research Records Manager to support the conduct of clinical research trials at the AbbVie Clinical Pharmacology Research Unit (ACPRU). As a key member of our team, you will be responsible for managing records management activities, ensuring compliance with regulatory requirements, and providing guidance to direct reports.

Key Responsibilities:

  • Manage the GCP clinical site documentation activities, including facilitating study protocol reviews, drafting informed consent forms, and coordinating and submitting IRB and sponsor trial master files.
  • Supervise the creation, collection, maintenance, and submission of essential documents for clinical studies conducted at the ACPRU.
  • Act as the liaison between the ACPRU and the sponsor clinical teams, as well as between the ACPRU and the IRB.
  • Ensure Institutional Review Board (IRB) approvals are received on time for study start-up.
  • Continually assess ACPRU records management activities for compliance with study protocols, departmental SOPs, and ICH GCP and FDA regulations.

Requirements:

  • Bachelor's degree preferred or Associate's degree required with relevant work experience.
  • 5 years of experience in a medical environment or healthcare organization, with familiarity with clinical research or quality assurance and AbbVie quality assurance, clinical research, or R&D systems.
  • 2 years of experience using Windows-based word processing, spreadsheet, presentation, graph, and table software, with database experience preferred.
  • 2 years of familiarity with CAPA process.
  • 5 years of familiarity with medical terminology or regulatory documents.
  • 5 years of proven ability to work in a team atmosphere.

What We Offer:

  • A comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
  • Opportunities for professional growth and development.
  • A collaborative and dynamic work environment.


  • Chicago, Illinois, United States Pillar Clinical Research, LLC Full time

    Job Title: Licensed Practical Nurse (LPN) or Emergency Medical Technician (EMT)Job Summary:Pillar Clinical Research, LLC is seeking a skilled Licensed Practical Nurse (LPN) or Emergency Medical Technician (EMT) to join our inpatient clinical research team. As a key member of our research team, you will be responsible for providing high-quality patient care...


  • Chicago, Illinois, United States Pillar Clinical Research LLC Full time

    Job Summary: We are seeking a skilled Licensed Practical Nurse (LPN) to join our inpatient clinical research team at Pillar Clinical Research LLC. As an LPN, you will play a vital role in providing compassionate and comprehensive nursing care to patients participating in clinical research studies.Key Responsibilities:Patient Care: Provide direct nursing care...


  • Chicago, Illinois, United States Medasource Full time

    Job Title: Clinical Research Coordinator IIIJob Summary: We are seeking a highly organized and detail-oriented Research Coordinator III to join our team at Medasource. In this role, you will be responsible for coordinating all clinical research activities, ensuring strict adherence to study protocols and regulatory requirements.Key Responsibilities:Manage...


  • Chicago, Illinois, United States The University of Chicago Full time

    Clinical Research Data Manager Job SummaryThe University of Chicago's Respiratory Clinical Research team is seeking a skilled Clinical Research Data Manager to support the conduct of clinical research studies. As a key member of the team, you will be responsible for managing research data, ensuring adherence to protocols, and maintaining the quality of...


  • Chicago, Illinois, United States RPM ReSearch Full time

    Job OverviewAs a Senior Manager Microbiology Research and Development at RPM ReSearch, you will be responsible for leading a team of microbiologists in the development of new antimicrobial products and technologies. This role requires a strong background in microbiology and experience in managing research and development teams.Key ResponsibilitiesLead a team...


  • Chicago, Illinois, United States University of Chicago Full time

    Job SummaryAs a Clinical Research Data Manager at the University of Chicago, you will be responsible for managing all data management tasks in support of high complexity clinical research studies. This role requires a high degree of confidentiality and expertise in clinical research and related aspects of clinical studies.Key Responsibilities• Oversee...


  • Chicago, Illinois, United States The University of Chicago Full time

    Job SummaryThe Senior Clinical Research Coordinator is a specialized researcher partnering with the clinical Principal Investigator (PI) and under the direction of the Section Administrator and/or Clinical Research Manager within the Section of Pulmonary/Critical Care Medicine in the Department of Medicine.While the Principal Investigator is primarily...


  • Chicago, Illinois, United States The University of Chicago Full time

    About the RoleThe University of Chicago is seeking a highly skilled Senior Clinical Research Coordinator to join our team in the Department of Medicine. This is a specialized researcher position that will partner with the clinical Principal Investigator and under the direction of the Section Administrator and/or Clinical Research Manager within the Section...


  • Chicago, Illinois, United States RPM ReSearch Full time

    Job SummaryThe Senior Manager Microbiology Research and Development will lead a team of microbiologists in the development of new antimicrobial products and the qualification of existing products. This role requires a strong understanding of microbiology and the ability to work in a fast-paced environment.Key ResponsibilitiesPlan, resource allocation, and...


  • Chicago, Illinois, United States Insight Hospital and Medical Center Full time

    Job Summary:We are seeking a highly motivated and experienced Clinical Research Regulatory Specialist to join our team at Insight Hospital and Medical Center in Chicago, IL. As a key member of our research team, you will be responsible for ensuring the compliance of our clinical trials with regulatory requirements and industry standards.Key...


  • Chicago, Illinois, United States AbbVie Full time

    About the Role:This position supports AbbVie's global Clinical R&D organization and will interact with attorneys in the Legal Division and R&D business.The position reports to Senior Paralegal II, Clinical R&D Legal and sits in AbbVie's Lake County, IL HQ Office in a hybrid capacity.Responsibilities:Works independently on a wide variety of clinical research...


  • Chicago, Illinois, United States Spectraforce Technologies Full time

    Job Title: Clinical Research DirectorJob Summary:We are seeking a highly skilled Clinical Research Director to oversee the direction, planning, execution, and interpretation of clinical trials or research activities of a clinical development program. The ideal candidate will have a strong background in clinical research, excellent communication skills, and...


  • Chicago, Illinois, United States The University of Chicago Full time

    Job SummaryThe University of Chicago is seeking a Clinical Research Nurse to join the Department of Medicine, Section of Cardiology. The successful candidate will work under the supervision of the Clinical Research Manager and Principal Investigator(s) of assigned studies, participating in the conduct of clinical research projects/studies involving various...


  • Chicago, Illinois, United States Ascension Full time

    Job SummaryAscension is seeking a highly skilled Clinical Research Coordinator to join our team. The successful candidate will be responsible for coordinating administrative and clinical aspects of multiple research projects. This includes collaborating with primary investigators, sponsors, and research staff to plan, conduct, and evaluate project protocols....


  • Chicago, Illinois, United States AbbVie Full time

    Job DescriptionAbbVie is a leading biopharmaceutical company that is committed to discovering and delivering innovative medicines and solutions that solve serious health issues. We are seeking a highly skilled Paralegal to support our global Clinical R&D organization.The successful candidate will interact with attorneys in the Legal Division and R&D...


  • Chicago, Illinois, United States Ascension Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Ascension. The successful candidate will be responsible for coordinating administrative and clinical aspects of multiple research projects, collaborating with investigators, sponsors, and research staff to plan, conduct, and evaluate project...


  • Chicago, Illinois, United States Chicago ENT Full time

    Job Title: Clinical Research CoordinatorChicago ENT is seeking a highly motivated and detail-oriented Clinical Research Coordinator to support our clinical research studies. The successful candidate will work under the general direction of the PI and leadership within Chicago ENT, in accordance with established institutional policies and laboratory...


  • Chicago, Illinois, United States ECN Operating LLC Full time

    Job Title: Clinical Research AssistantDepartment: Site OperationsReports To: Site ManagerLocation: Research InstituteStatus: Non-exempt (hourly)Compensation: $17 - 19Position Summary:We are seeking a reliable and experienced Medical Assistant to join our team at ECN Operating LLC. This position will be responsible for conducting patient visits, documenting...


  • Chicago, Illinois, United States Rush University Full time

    Job Summary:The Clinical Research Coordinator will support the Office of Research Affairs' Clinical Research Administration Division, their clinical department / division, and in partnership with the Principal Investigator (PI), Co-Investigator(s), other study personnel, and sponsoring agents to ensure protocols are conducted in accordance with the...


  • Chicago, Illinois, United States Lifelancer Full time

    Job Title: Clinical ScientistJob Description:In collaboration with a therapeutic area Medical Director or Scientific Director, the Clinical Scientist will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist will apply scientific training and clinical research experience to support all aspects of drug...