We are looking for a Regulatory Document 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 check.

Please include a short cover letter with answers to the following questions:

  • Why would you be a good candidate for this position?
  • Any gaps in your employment history? Please explain.
  • What are your salary expectations?
  • Are you authorized to work in the United States?
  • Do you now or will you in the future require sponsorship for employment visa status (e.g., H-1B visa status)?

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 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 a comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)

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, gender, 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.