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Document Control Administrator I

Quality Assurance and Compliance – Aurora, Colorado
Department Quality Assurance and Compliance
Employment Type Full-Time
Minimum Experience Entry-level

We are looking for a Document Control Administrator to join our team! You need to have passion for working with people, good computer skills, be organized and have a knack for details! Sounds like you? Read on…

In this position you will:

  • Adhere to local, federal and international regulations, guidelines and CPC Policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs).
  • Perform routine quality control (QC) of Trial Master File (TMF) and submitted documents to ensure overall quality.  Provide feedback to CRAs, Clinical Trial Managers, Project Managers as well as all individuals uploading documents to the TMF, as necessary.
  • Initiate project-related training within MasterControl.
  • Oversee and assist with creation of Organizers within MasterControl.
  • Set up and manage electronic files in MasterControl.
  • Assist with the creation of document InfoCards, as necessary.
  • Assist in the development, review and revision of SOPs and WIs, as assigned.
  • Identify gaps in staff training, processes, as well as CPC SOPs and WIs.  Work with appropriate personnel to provide additional training and/or to revise the process, SOP and/or WI. 
  • Mentor and train individuals, when applicable.
  • Cross-train within the organization, as necessary.

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

  • Minimum of 1 year of clinical operations experience.
  • Understanding of the drug development process and TMF maintenance.
  • Knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials. 
  • Experience in Microsoft Windows and Microsoft Office. 
  • Excellent interpersonal communication skills, organizational skills and a great attention to detail.  
  • Ability to work independently as well as on a team.
  • Ability to coordinate and lead 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.

    Note: Viable applicants will be required to demonstrate their computer skills as well as pass a background and education verification check.

    About CPC:

    CPC is an academically led clinical 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 25 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
    • 10 paid holidays
    • In-suite exercise room
    • In-suite relaxation room
    • In-office masseuse 3x/month
    • Monthly fun events (i.e. sports games, potlucks, picnics)
    • Flexible work schedules

    Visit our web site to learn more about us and values we embrace: www.cpcmed.org.

    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 40 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 e-mail our Human Resources team. 

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    • Location
      Aurora, Colorado
    • Department
      Quality Assurance and Compliance
    • Employment Type
    • Minimum Experience
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