Clinical Quality Specialist (eTMF), Regional, East Coast

Durham, NC

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 Specialist (eTMF) preferably based in Research Triangle Park, North Carolina, Franklin Lakes, New Jersey, or Sparks, Maryland.  The Clinical Quality Specialist (eTMF) will support and serve as a key resource for clinical operations activities, including administration, training, tracking and support for clinical electronic trial master files. Their work will have a direct impact on advancing the world of health making this an amazing career opportunity.

RESPONSIBILITIES

  • Performs as eTMF System Administrator, including assigning new users and performing version validations on system upgrades
  • Uploads new and revised forms and templates to support clinical study conduct 
  • Trains associates as required on proper usage of eTMF
  • Assists in daily usage as required and periodic quality checks of study files 
  • Develops reporting metrics for tracking and trending within a project or across projects  
  • Responsible for ensuring that work within CCD systems and processes are executed in a manner consistent with company standards, and compliant with applicable laws and regulations

EXPERIENCE 

  • 5 years of experience with clinical trial support
  • Experience with preparation and handling of clinical trial documentation
  • Experience managing eTMF
  • Working knowledge of Microsoft Office: Excel, Word, Outlook
  • Must have experience working in large electronic systems and databases
  • Must understand Clinical Study documentation requirements and translate into established processes
  • Current experience with Veeva Vault eTMF preferred
  • Experience conducting clinical trials and familiarity with GCP a plus
  • Prefer medical device or In Vitro Diagnostic experience with PMA and 510(k) experience from a clinical trial compliance perspective

EDUCATION

  • A minimum of a Bachelor’s Degree is required, preferably in Science with a Clinical Research Certification

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