Clinical Trial Project Manager jobs in Chicago, IL

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Clinical Trial Monitor
  • Alliance for Clinical Trial in Oncology Foundation
  • Schiller Park, IL FULL_TIME
  • Purpose/Scope:

    The Clinical Trial Monitor will work under the Director of Industry Collaboration and Trial Management to oversee trial activity at sites participating in Alliance clinical trials. This position is responsible for completing clinical monitoring activities at participating sites for assigned trials. This includes Source Data Verification (SDV) of clinical study data entered on the Case Report Forms (CRF) in the Electronic Data Capture (EDC) system, review and reconciliation of the Investigational Site File (ISF) in line with NCTN mechanisms, confirm proper utilization and documentation of Investigational Product (IP), and ensure overall adherence to protocol procedures.

    Role and Responsibilities

    Conduct remote/on-site monitoring visits to ensure compliance with study protocols, clinical monitoring plan, Good Clinical Practice (GCP), institutional policy, and other applicable regulations.

    Draft monitoring reports per trial’s established needs and expectations.

    Perform source data verification (SDV) and review clinical documents for accuracy and completeness.

    Cross-functional collaboration including with data management, quality, regulatory, and clinical operations.

    Identify potential issues and risks and contribute to risk mitigation.

    Conduct training for contracted monitors, with support of other team members.

    Perform quality checks for contracted monitors.

    Conduct co-monitoring visits as a sponsor representative.

    Serve as a Subject Matter Expert for external monitors to consult with, with support of the internal team.

    For assigned sites and/or trials, provide guidance to sites for inspection-readiness aspects including protocol requirements; study procedures; data integrity; regulatory expectations; training; protocol deviations and Corrective and Preventive Action Plan implementation.

    Support site adherence with GCP and other applicable regulations

    Provide guidance on Investigator Site File and other relevant regulatory expectations, in line with NCI’s NCTN mechanisms.

    Support data entry timeliness per Alliance policies

    Assist sites in addressing and resolving data discrepancies and other queries.

    Contribute to the development of the scope of work for monitoring services, and associated study plans, e.g., clinical monitoring plan.

    Adhere to the protocols' Clinical Monitoring Plan, e.g., monitoring visit type, frequency, and required critical monitoring activities.

    Coordinate upcoming and ongoing monitoring assignments while meeting expected timelines for the completion of monitoring activities including submission of monitoring reports.

    Builds positive relationships with principal investigators and site personnel and actively participate with the study team to stay current with study needs.

    Requirements

    Qualifications and Education Requirements

    Registered nurse or bachelor’s degree in a relevant life science field

    Experience in therapeutic trials, oncology strongly preferred: 2 years experience in on-site monitoring as a Clinical Research Associate or 4 years experience as a Clinical Research Coordinator

    In-depth knowledge of GCP, ICH guidelines, and other applicable regulatory requirements

    Current certification of the Collaborative Institutional Training Initiative (CITI Program) GCP training or the ability to successfully complete training within 1 month of hire

    Proficient in navigating Electronic Medical Record systems.

    Proficient in using electronic data capture platforms and clinical trial management systems.

    Ability to travel on a routine basis.

    Preferred Skills

    Excellent communication, interpersonal, and problem-solving skills

    Ability to work independently and collaboratively in a fast-paced environment.

    Strong organization skills with attention to detail

    Fully COVID-19 Vaccinated

    Benefits

    100% Medical Option, Dental & Vision for employee, with 50% spouse and children - begins on the 1st day of employment

    20 Days PTO, 10 Sick Days & 10 Holidays Off (Already Designated)

    Tuition Reimbursement

    Match 3% of a Simple IRA.

    50% Transit or Parking paid

    Annual Employee Bonus Program

    Annual Cost of Living Increase

  • 10 Days Ago

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Clinical Trial Manager
  • Belcan Corporation
  • Northbrook, IL FULL_TIME
  • Details: Job Title: Clinical Trial ManagerLocation: Northbrook, IL or Remote Pay: $81-101/hour (DOE)Zip Code: 60062Start date: ASAPA Clinical Trial Manager job is now available through Belcan. This is...
  • 6 Days Ago

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Clinical Trial Coverage Analyst
  • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Chicago, IL FULL_TIME
  • 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 d...
  • 23 Days Ago

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Clinical Trial Lead
  • Belcan Corporation
  • Northbrook, IL FULL_TIME
  • Details: Job Title: Clinical Trial LeadLocation: Northbrook, IL or Remote Pay: $100-120/hour (DOE)Zip Code: 60062Start date: ASAPA Clinical Trial Lead job is now available through Belcan. This is a co...
  • 6 Days Ago

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Clinical Trial Associate
  • Astellas Pharma
  • Northbrook, IL OTHER
  • Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients ...
  • 13 Days Ago

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Clinical Trial Coverage Analyst
  • 10 HOSP Ann & Robert H. Lurie Children's Hospital of Chicago
  • Chicago, IL FULL_TIME
  • 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 d...
  • 13 Days Ago

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0 Clinical Trial Project Manager jobs found in Chicago, IL area

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Clinical Trials Manager/Senior Clinical Trials Manager
  • Exicure, Inc.
  • Chicago, IL
  • The Clinical Trials Manager/Senior Clinical Trials Manager is responsible for planning, executing, and monitoring a clin...
  • 3/28/2024 12:00:00 AM

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Clinical Program Coordinator - Parks Francis and Medical District
  • YWCA Chicago
  • Chicago, IL
  • POSITION TITLE: Clinical Program Coordinator STATUS: Exempt, FT GRADE: 4 DEPT: Safety & Wellness PROGRAM: SVSS Clinical ...
  • 3/28/2024 12:00:00 AM

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RN Clinical Quality Research Analyst (HEDIS)
  • HCSC
  • Chicago, IL
  • At HCSC, we consider our employees the cornerstone of our business and the foundation to our success. We enable employee...
  • 3/28/2024 12:00:00 AM

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Senior Clinical Research Monitor, Midwest
  • Edwards Lifesciences Corp
  • Chicago, IL
  • Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate...
  • 3/28/2024 12:00:00 AM

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Clinical Research Manager (Ophthalmology)
  • Northwestern University
  • Chicago, IL
  • Department: MED-Ophthalmology Salary/Grade: EXS/7 Job Summary: Oversees the Department of Ophthalmology research program...
  • 3/27/2024 12:00:00 AM

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Research Assistant - Center for Rehabilitation Outcomes and Research - Part-Time
  • Shirley Ryan Ability Lab
  • Chicago, IL
  • By joining our team, you'll be part of our life-changing Mission and Vision. You'll work in a truly inclusive environmen...
  • 3/27/2024 12:00:00 AM

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Medical Science Liaison, Multiple Myeloma/Lymphoma (Chicago, IL)
  • Bristol Myers Squibb
  • Chicago, IL
  • Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But w...
  • 3/25/2024 12:00:00 AM

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Clinical Research Project Manager-172487
  • Medix™
  • Chicago, IL
  • This position is responsible for overseeing, organizing and implementing multiple clinical research trials being conduct...
  • 3/24/2024 12:00:00 AM

Chicago (/ʃɪˈkɑːɡoʊ/ (listen), locally also /-ˈkɔː-/), officially the City of Chicago, is the most populous city in Illinois, as well as the third most populous city in the United States. With an estimated population of 2,716,450 (2017), it is the most populous city in the Midwest. Chicago is the principal city of the Chicago metropolitan area, often referred to as Chicagoland, and the county seat of Cook County, the second most populous county in the United States. The metropolitan area, at nearly 10 million people, is the third-largest in the United States, and the fourth largest in North A...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Trial Project Manager jobs
$63,341 to $84,542
Chicago, Illinois area prices
were up 0.8% from a year ago

Clinical Trial Project Manager
Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with study teams.
December 07, 2022
Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
December 28, 2022
Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed.
January 05, 2023
Participates in meetings with internal Grifols departments including Quality, Stability, Regulatory, and Bio Analytics.
January 19, 2023
Manages and maintains appropriate levels of CTM supplies for assigned trials throughout lifecycle of trial per GCP/GMP including initiating and tracking CTM shipments, shipment receipts, depot inventories, site inventories, IVR-IWR functionality, lot numbers, expiry dates, packaging randomization codes, drug accountability, and other necessary documentation as defined on a per study basis.
February 13, 2023
Serves as liaison to study sponsors, clinical trial sites, pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit, as needed.
March 03, 2023
Assists in managing Clinical Operations personnel in protocol development, Institutional Review Board submissions, scheduling, staffing, work flow and any other requirements necessary for the initiation, conduct, and completion of a clinical project.
April 15, 2023
Develops quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
May 20, 2023