Clinical Trial Project Manager jobs in the United States

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Clinical Trial Manager I
  • CPC Clinical Research
  • Aurora, CO OTHER
  • We are looking for a Clinical Trial Manager I to join our team!

     

    Are you well organized and adaptable to unexpected changes? Someone who is able to see the bigger picture, without losing sight of the day-to-day tasks? If the answer is yes, keep reading!

     

    Clinical Trial Manager I serves as the primary point of contact for clinical trials site operations. 


    Remote candidates are welcome to apply.

     

    In this position you will:

     

    • Serve as the secondary contact to address site questions when the site Clinical Research Associate (CRA) or Research Assistant (RA) is unavailable.
    • Ensure CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations are being followed.
    • Review monitoring visit reports and follow-up letters for Site Endpoint Evaluation Visits, Site Evaluation Visits, Site Initiation Visits, Routine Monitoring Visits, and Close-out Visits and Addendums and work with CRAs to clarify issues and finalize reports and follow-up letters.
    • Review site specific Informed Consent Forms (ICFs) to address site specific changes and escalate to internal or external parties for approval, as needed.
    • Provide the Project Manager with metrics and updates on sites including but not limited to: study related site enrollment, site activations, protocol deviations, monitoring reports and follow-up letters status.
    • Assure proper maintenance of site required records for monitoring activities and required regulatory documents per CPC requirements.
    • Create and/or review study-specific monitoring visit reports and, follow-up letter templates, and project specific site materials including Monitoring Plans, ICF templates, Study Procedure Manual, source document and site newsletter.
    • Work with CRAs, RAs and Clinical Trial Managers on overall site management including identification, escalation and resolution of site related compliance issues.
    • Support Investigational Product (IP) release and once IP release has occurred, work with the RAs to collect all new or expiring Investigator regulatory documents.
    • Support site activations and IP release.
    • Participate in project-related and other departmental/CPC meetings as required.
    • Assist with the selection of qualified sites and Investigators for participation in research protocols.
    • Assist with negotiation of study site budget. Oversee tracking, request and work with the Finance department on processing study site payments.
    • Attend project team meetings as necessary and provide CRAs with updated study information to support their monitoring activities.
    • Work closely with other team members to ensure timely resolution of site issues.
    • Conduct drug tracking and disposition as required by project.
    • Assist in oversight of remote monitoring.
    • Ensure Clinical Trial Management System (CTMS) remains up to date with all site trial activities including but not limited to site communications, document status, monitoring visits, protocol deviations.
    • Conduct site monitoring visits or co-monitoring visits, as needed.
    • Additional duties as required.

      

    Here’s what you will need to bring to the table:


    • Nursing or bachelor’s degree preferred.
    • A minimum of 2 years of experience in clinical research setting required, experience in monitoring or clinical trial management preferred.
    • Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
    • Thorough understanding of the drug development process.
    • Proficiency in Microsoft Office Suite (Excel, Word, Outlook, PowerPoint).
    • Experience with electronic data capture systems.
    • Excellent interpersonal communication skills, organizational skills and a great attention to detail.
    • Ability to organize and instruct staff, while promoting group effort and achievement.
    • Ability to carry out multiple tasks simultaneously.
    • Ability to complete tasks in an accurate and timely manner.
    • Ability to manage conflicts and resolve problems effectively.
    • Ability to discern priorities with minimal direction to accomplish day-to-day tasks.
    • Willingness to travel up to 25% of the time.

     

    Note: Viable applicants will be required to pass a background and education verification check.

     

    Targeted Compensation: $61,000 - $72,000 annually

     

    Deadline to Apply: February 1, 2024


    About CPC:


    CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.

     

    CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.

     

    CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/

     

    CPC offers:


    • Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
    • Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
    • 10 paid holidays
    • 15 - 25 vacation days based on years of service
    • Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours) 
    • In-suite exercise and relaxation room
    • Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
    • Flexible and remote work schedules

     

    An Equal Opportunity Employer


    CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.

     

    Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.

  • 1 Month Ago

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Project Manager (Clinical Trial Oversight)
  • GAP Solutions
  • Bethesda, MD FULL_TIME
  • Position Objective: Provide services as a Project Manager (Clinical Trial Oversight) in support of the overall functions of the Vaccine Research Center (VRC), Clinical Trials Program (CTP) within the ...
  • 5 Months Ago

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Clinical Trial Project Manager-Pharmacology
  • Medpace, Inc.
  • Cincinnati, OH OTHER
  • Job Summary Medpace Clinical Pharmacology, a 96-bed facility specializing in early phase clinical trials, is led by a team of highly trained clinical researchers who are experts in the design, impleme...
  • 7 Months Ago

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Clinical Trial Project Manager (Homebased)
  • 5TA US Quintiles Laboratories
  • Marietta, GA FULL_TIME
  • Q2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentles...
  • 20 Days Ago

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Clinical Trial Activation Project Manager
  • University of North Carolina - Chapel Hill
  • Chapel Hill, NC FULL_TIME
  • Posting Information Posting Information Department LCCC - Clinical Trials-426806 Career Area Research Professionals Posting Open Date 02/06/2024 Application Deadline 02/26/2024 Open Until Filled No Po...
  • 20 Days Ago

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Project Manager with Clinical trial experience
  • Agama Solutions
  • Oakland, CA FULL_TIME
  • Backfill position. Our candidate wants to be FTE with Kaiser and he is pressurizing the manager a lot. and that upset the manager, now he wants to backfill him. Only GC/citizen/EAD candidate Title: So...
  • Just Posted

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Clinical Trial Associate (REMOTE)
  • Actalent
  • Gaithersburg, MD
  • Position Summary: The CTA will work with Clinical Operations team to support the conduct of clinical trials. The CTA may...
  • 2/29/2024 12:00:00 AM

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Clinical Trial Associate (REMOTE)
  • Careerbuilder
  • Gaithersburg, MD
  • Position Summary: The CTA will work with Clinical Operations team to support the conduct of clinical trials. The CTA may...
  • 2/29/2024 12:00:00 AM

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Research Associate I - Prostate Cancer
  • Henry M. Jackson Foundation
  • Bethesda, MD
  • Overview Join the HJF Team! The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofi...
  • 2/29/2024 12:00:00 AM

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Research Assistant
  • George Washington University
  • Rockville, MD
  • I. DEPARTMENT INFORMATION Job Description Summary: The Biostatistics Center is an off-campus research facility of The Ge...
  • 2/29/2024 12:00:00 AM

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Scientist / Senior Scientist, Cancer Immunotherapy
  • CELLICURE INC
  • Germantown, MD
  • Job Description Job Description Background Cellicure, Inc. is a biotechnology company focusing on the development of inn...
  • 2/29/2024 12:00:00 AM

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Biostatistician I
  • George Washington University
  • Rockville, MD
  • Posting Details I. DEPARTMENT INFORMATION Job Description Summary: The Biostatistics Center of the Milken Institute Scho...
  • 2/27/2024 12:00:00 AM

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Research Assistant I
  • Henry M. Jackson Foundation
  • Bethesda, MD
  • Overview Join the HJF Team! The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF) is a nonprofi...
  • 2/27/2024 12:00:00 AM

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Staff Clinical Project Manager (Remote)
  • Careerbuilder
  • Washington, DC
  • Wondering what's within Beckman Coulter Diagnostics? Take a closer look. At first glance, you'll see that for more than ...
  • 2/25/2024 12:00:00 AM

Income Estimation for Clinical Trial Project Manager jobs
$59,891 to $79,936