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Study Start- Up Administrator (Contract, Office-Based) - Novella Clinical (R1054606) in Morrisville, NC at IQVIA™

Date Posted: 1/3/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/3/2019
  • Job ID:
    R1054606

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

Novella Clinical is now hiring for a contract Study Start- Up Administrator to sit in our Raleigh-Durham, NC office.

BASIC FUNCTIONS:

Responsible for maintaining   Novella database(s) and assisting with ISSC Department efforts to ensure the quality and regulatory compliance of Principal Investigator (PI) credentials, Essential Documents (ED) and Investigator Site Files (ISF) throughout the clinical study.  Work with both internal and external teams to ensure good communication regarding documentation processing.  Assists with maintaining documents in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Novella and its clients. 

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Assists with the entry of Investigator names in the Clinical Trial Management System (CTMS) database.
  • Support Associate with feasibility packet development e.g. UAT for eFQ.
  • Assists with the creation of templates for regulatory documents specific to local and central Institutional Review Board (IRB) / ethics committee submissions.
  • Updates  Novella database(s) as documents are received by ISSC team members.
  • Assists in scanning site documents to the shared (G) drive and file using filing conventions.
  • Assists with the filing of documents into ISFs.
  • Assists with, tracking and filing of reportable expedited safety reports and cross reports to sites as needed.
  • Documents study challenges and effectively communicate those to the ISSC Associate, Lead and/or ISSC Manager.
  • Assists the ISSC Leads and ISSC Managers with reports as needed.
  • Copy and assemble documents as required.
  • Conducts all activities according to appropriate Novella and/or sponsor SOPs.
  • Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

  • Strong written and verbal communication skills to express complex ideas to team members.
  • Excellent organizational and interpersonal skills.
  • Positive attitude and ability to interact with all levels of staff.
  • Ability to manage multiple priorities.
  • Demonstrated ability to use sound judgment and assess and recommend specific solutions.

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor Degree, preferably in the field of science.
  • Excellent verbal and written communication skills. 
  • Ability to work somewhat independently, prioritize effectively and work within a matrix team environment.
  • Working knowledge of Word, Excel and Power Point.

CRITICAL JOB FUNCTIONS:

  • Limited travel may be required.
  • Very limited physical effort required to perform normal job duties.

CLASSIFICATION:

This position is classified as non-exempt under the Fair Labor Standards Act; employees are eligible for overtime compensation subject to prior approval.

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

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1054606