Clinical Quality Assurance CAPA Reviewer

King of Prussia, PA

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as a Clinical Quality Assurance CAPA Reviewer in King of Prussia, Pennsylvania, with potential to work remotely after training.  The Clinical Quality Assurance CAPA Reviewer role will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Finding observation from audits from clinical site, vendor site, clinical labs
  • Review Clinical Audit reports and enter all observations and CAPA into Trackwise in addition to the evidence of closure of the observation
  • Assist with restructuring and organizing documents in SharePoint

EXPERIENCE

  • Must have clinical Quality (GCP) experience
  • Comfortable with closing out CAPAs
  • Trackwise experience and clinical background and study documentation (Quantum is similar to Trackwise and would be considered) required
  • Solid experience with clinical documentation (TMF), and corrective action
  • SharePoint experience preferred

EDUCATION

  • Bachelor’s Degree in related area required

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

847-267-1176