Clinical Trial Assistant (Informed Consent)

East Hanover, NJ

Contract

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OVERVIEW

At Advanced Clinical, we’re excited to share with you a great opportunity at growing organization for the position of Clinical Trial Assistant (CTA),  in the area of Informed Consent Form and Confidentiality Agreements (ICF/CDA). The Clinical Trial Assistant will be trained on entry level negotiation of certain sections of the Informed Consent Form (ICF) and entire CDA, and will be provided with tools and manuals to perform common approved changes to these documents.  This 6-month position is located in East Hanover, New Jersey.

RESPONSIBILITIES

  • Review and negotiate the sections of the ICF pre-IRB submission, post IRB comments, confirms the language used in the approved ICF is acceptable and works on Amended ICFs
  • Review and negotiate the CDAs and confirms the language used in the CDA is acceptable and approved
  • Ensure CREDI-approved ICF is used as the base for the US Customized ICF template for the study
  • Interface with the clinical sites, IRBs, the portfolio Specialists, the Contract manager, and the Trial Leader 
  • Work with vendors such as central IRBs to aid in negotiating standard language in the ICF
  • Ensure study ICF-template for central IRB sites contain the approved pre-negotiated language 
  • Maintain electronic ICF repository of approved ICFs 
  • Work to log alternate, pre-approved CDA and ICF language Support team with administrative tasks including, but not limited to, filing, tracking and metrics maintenance

EXPERIENCE

  • Knowledge of ICF and CDA language 
  • Knowledge of PHI and HIPAA highly preferred 
  • Strong Computer Skills, specifically Microsoft Word, Excel 

EDUCATION

  • Bachelor’s Degree 

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