Are you someone who is organized and has a knack for details? Someone with background in clinical research quality assurance? Someone who is able to see the bigger picture and adapts to change easily? If the answers are yes, keep reading!

In this position you will:

  • Oversee management, implementation and administration of CPC’s regulatory and Quality Management System (QMS), programs and activities.
  • In conjunction with the Executive Committee, identify process gaps and revise policies (POLs), standard operating procedures (SOPs) and work instructions (WIs) to ensure compliance with applicable regulations and guidances.
  • Monitor the development, periodic review, revision, approval, version control, and historical archival of controlled documents within the QMS.
  • Serve as a regulatory representative for computerized systems acquisition, implementation, maintenance, and retirement initiatives.
  • Address and resolve any questions or issues of a regulatory or quality assurance nature with the assistance of external resources. Report all suspected misconduct or fraud to the President and/or the COO. Report all significant or concerning regulatory and/or quality issues to the President and inform the COO.
  • Meet monthly with the President to review any internal audit findings, CPC QMS Review Reports, quality trends, CAPA resolutions, etc.
  • Oversee internal auditing functions utilizing internal and external resources to ensure compliance with all applicable local, federal and international regulations, guidelines and standards.
  • Oversee external auditing functions for clinical sites, vendors, subcontractors, partners, third-party CROs and others as appropriate.
  • Represent CPC in interactions with the FDA and other regulatory bodies.
  • Serve as a principal contact during external audits of CPC and respond to audit observations or requests, in conjunction with appropriate Executive Committee members.
  • Oversee field monitoring performance assessments.
  • Understand and comply with all applicable regulations for clinical trials and relevant CPC POL, SOPs and WIs.
  • Work with the Director, Clinical Research on evaluating departmental, personnel and productivity metrics to assess and implement necessary changes and/or improvements.
  • Work with the assigned functional leads, if applicable, to ensure timelines are being met, deliverables are in compliance with applicable POLs, SOPs, WIs as well as applicable regulations and guidelines.
  • Oversee, develop and/or review regulatory and other assigned clinical trial documents for GCP compliance and report findings to applicable functional area(s) and Director, Clinical Research.
  • Prepare and implement training programs and assist with the development of cross-departmental training programs.

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

  • Bachelor’s degree (preferred, but equivalent experience will be considered).
  • Minimum of 5 years of experience in quality assurance with at least 3 years in clinical research setting required including regulatory responsibilities.
  • Knowledge of applicable regulatory requirements (e.g. ICH, GCP and FDA) for conducting clinical trials.
  • Proficiency with Microsoft Office, particularly Word and Excel.
  • Excellent organizational skills, communication skills and attention to detail.
  • Ability to work as a member of a team and establish a strong team environment for direct reports (if applicable).
  • Good problem-solving skills and ability to prioritize and manage multiple tasks independently.
  • Ability and willingness to travel up to 15%.

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

This is not a remote position; you will work the majority of time in the office in a team environment.

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

Please e-mail your resume and a short cover letter with answers to the following questions to careers@cpcmed.org:

  • Why would you be a good candidate for this position?
  • How many years of relevant experience do you have?
  • 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 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 a comprehensive benefits package (medical, dental, vision, life, Gap Plan, FSA, STD, LTD, 10 paid holidays, matching 401k etc.) as well as other perks (in-suite relaxation room, exercise room, chair massages, monthly fun events, potlucks).

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 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 email our Human Resources team.