Senior Clinical Trial Associate (Home/Office-Based) - IQVIA Biotech (R1085738) in Rochelle Park, NJ at IQVIA™

Date Posted: 6/28/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    6/28/2019
  • Job ID:
    R1085738

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

BASIC FUNCTIONS:

The primary role of the Sr. Clinical Trial Associate position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. Will act as a pivotal point of contact and support for the Project Management team and function as a mentor/trainer for entry level staff. The Sr. Clinical Trial Associate may travel up to 30% to Project Management Team meetings or for other business-related reasons.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies.
  • Prepare, collect and provide support to sites on essential document collection and maintenance.
  • Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper).
  • Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File.
  • Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions.
  • Assist Clinical Trial Manager (CTM) with development of Informed Consent Form Template (ICF).
  • Coordinate with Recruitment Management regarding advertising submissions to IRB.
  • Prepare Drug Release Authorization forms and collect required documentation.
  • Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
  • Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF.
  • Assist CTM with tracking of clinical trial agreements (CTA) with Investigator Sites.
  • Prepare and coordinate materials (e.g. binders, agendas, meeting minutes, slide presentations) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF).
  • Perform data entry into electronic systems (i.e. CTMS) for study or client information.
  • May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • Communicate with sites on issues escalated by a monitor and/or the CRA Manager.
  • Train entry level personnel Clinical Trial Associate (CTA) I and/or Project Assistant (PA)
  • Perform administrative tasks to support team members with clinical trial execution as needed.

KNOWLEDGE, SKILLS AND ABILITIES:

  • General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.
  • Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
  • Strong written and verbal communication skills.
  • Effective time management and organizational skills.
  • Attention to detail and accuracy in work
  • Aptitude for handling and proofreading data.
  • Strong customer service orientation.
  • Ability to function as a trainer/mentor for entry level staff.
  • Ability to function independently with minimal supervision
  • Ability to travel (e.g., Investigators Meetings)

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very little physical effort required to perform normal job duties (unless otherwise indicated)

MINIMUM RECRUITMENT STANDARDS:

College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) with related work experience.

Or

≥ 3 years’ experience at Novella Clinical in a project team position or working within the health sciences field in a similar position.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled

IQVIA, Inc. provides reasonable accommodations for applicants with disabilities.  Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at workday_recruiting@iqvia.com to arrange for such an accommodation.



Job ID: R1085738