Clinical Studies Specialist

Lake Bluff, IL

Contract

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OVERVIEW

Now hiring for a hungry Clinical Studies Specialist who has a generous spirit, is committed to creating change and is committed to the pharmaceutical industry. The Clinical Studies Specialist position is located in the northern suburbs of Chicago, Illinois, and will be responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines.

RESPONSIBILITIES

  • Responsible for managing the Trial Master File (TMF), ensuring documents maintained in the file are appropriate and the content of those documents is accurate, complete and consistent with SOPs and regulatory requirements 
  • Support clinical team in tracking, organizing and filing Phase I-IV study documents according to Federal Regulations and ICH guidelines
  • Assist Clinical Team members in handling data queries, drug inventories, study invoice payments, enrollment tracking, and record reconciliation with site documents
  • Assists the CRAs with organizing and planning study investigator meetings

EXPERIENCE

  • A minimum of 3-5 years of clinical trials/clinical research, regulatory QA or document control experience

EDUCATION

  • Bachelor’s degree 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