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CPC

Clinical Trial Endpoint Project Manager

26 - Core Lab – Aurora, Colorado
Department 26 - Core Lab
Employment Type Full-Time
Minimum Experience Experienced

We are looking for a Clinical Trial Endpoint Project Manager to join our team!

In this position you would be working with an innovative proprietary program [Endpoint Quality Improvement Program (EQuIP)] to identify sources of data variability and intervene to improve overall clinical trial endpoints (e.g. 6 Minute Walk Test, Treadmill Tests, Wound Healing, Ankle/Brachial Index measurements).

In this position you will:

  • Project manage clinical trial endpoints (Core Lab/EQuIP services activities) including scope, timelines and deliverables from project initiation to closeout.
  • Schedule, plan for, and document project team meetings.  Assess Core Lab/EQuIP services issues, propose resolutions and track implementation.
  • Ensure that overall quality of project services and deliverables is maintained.
  • Develop project-specific Core Lab Manuals, Data Management Plans, WIs and other essential documents pertaining to core lab activities.
  • Oversee timely and accurate entry and cleaning of Core Lab/EQuIP data; maintain and file data management documentation.
  • Accurately track receipt, entry, upload and the processing of source documents submitted from sites.  
  • Contact appropriate individuals (study site staff or study site Clinical Research Associate) regarding incomplete, inaccurate, or missing Core Lab documents as required by project.
  • Provide status reports on all projects as necessary.
  • Participate in both onsite and offsite Investigator Meetings and training sessions.  

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

  • Nursing or bachelor’s degree preferred.
  • Project management experience preferred.
  • A minimum of 3 years of experience in a clinical research setting required.
  • Knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
  • Proficiency in MS Office (Excel, Word, Outlook, and PowerPoint).
  • Excellent interpersonal communication skills, organizational skills and a great attention to detail.
  • Ability to work as a member of a team and possess good problem solving skills.
  • Ability to manage conflicts and resolve problems effectively.

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

At this time CPC is not able to provide relocation assistance to out-of-state candidates.

About CPC:

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

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.) In addition, our team members get to enjoy in-suite exercise and relaxation room, chair massages and monthly fun committee events.

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 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 e-mail our Human Resources team at careers@cpcmed.org.

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  • Location
    Aurora, Colorado
  • Department
    26 - Core Lab
  • Employment Type
    Full-Time
  • Minimum Experience
    Experienced
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