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Start-up & File Maintenance Associate (Home/Office-based) - Novella Clinical (R1038190) in Morrisville, NC at IQVIA™

Date Posted: 12/6/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    12/6/2018
  • Job ID:
    R1038190

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 Start-Up & File Maintenance Associate home-based or in our Raleigh-Durham, NC office.

BASIC FUNCTIONS:

Provide oversight for ISSC study Maintenance timeline, coordinate study maintenance and close out activities with Maintenance Representative (MN-R). Responsible for site, client and internal team communication; mentoring and providing study specific trainings; distribution of amendments, safety reports and ICF reviews as applicable per region.   Ensuring that document process is 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:

  • Oversees efforts of file maintenance and study close out with team member for a designated project.
  • Works with ISSC Management to discuss projected hours for the assigned project and provides updates to appropriate project team member(s).
  • Serves as core team member in interactions with the sponsor and sites.
  • Responsible for study specific training and mentor staff as needed.
  • Provide oversight and QC site level documents for the quality and regulatory compliance from maintenance through close out phase.
  • Manages periodic investigator site file reviews on assigned project(s) to ensure compliance with GCPs and Novella’s standard operating procedures. And communicates findings with MN-R.
  • Leads the creation of the File Review Plan.
  • Oversees site level timelines. Documents study challenges and communicates them to the ISSC Manager, Sr. Mgr. or Associate Dir. and Project Manager.
  • Identifies out of scope activities to Project Manager/ ISSC Manager and team and assures that such activities are identified in the Change in Scope.
  • Assist in collection of the ongoing regulatory documents from sites as necessary.
  • Escalate any site file issues to ISSC management as appropriate.
  • Responsible to send updated documents (eg. 1572, FDF) to client on a monthly basis as required.
  • Responsible for review of the ongoing IRB/Ethic Committee (EC) documentation (i.e. IRB continuing review, Amendment approval) Site level ICF review, completion of ICF Checklist, and update tracking system as necessary and as applicable to region. 
  • Manages MN-R in ensuring that Investigator names are in the Clinical Trial Management System (CTMS).
  • Updates templates during maintenance phase for regulatory documents specific to local and central Institutional Review Board (IRB)/Ethics Committee (EC) submissions, as applicable per region.
  • Responsible for compiling and distribution of ongoing regulatory documents to sites, as required.
  • Assists sites with local IRB submissions as necessary.
  • Contacts sites as required to resolve issues before IRB submission and final review.
  • Oversees any additional duties as outlined in the Site Level TMF plan as applicable.
  • Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

  • Demonstrated ability in the leadership of a team of individuals in the ISSC type process activities.
  • Knowledge of clinical research process and medical terminology.
  • Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
  • Excellent organizational and interpersonal skills.
  • Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
  • Ability to manage multiple competing priorities within various clinical trials.
  • Working knowledge of current ICH GCP guidelines and applicable regulations.
  • Ability to reason independently, assesses and recommend specific solutions in clinical settings, and mentor entry level ISSC staff.

MINIMUM RECRUITMENT STANDARDS:

  • BS/BA/BSc, or equivalent level of education, with a minimum of 3 years direct regulatory collection and submission experience.
  • Excellent verbal and written communication skills required. 
  • Ability to work independently, prioritize and work with a matrix team environment is essential. 
  • Working knowledge of Word, Excel is required. 

CRITICAL JOB FUNCTIONS:

  • Ability to travel
  • Very limited physical effort required to perform normal job duties

CLASSIFICATION:

This position is classified as exempt under the Fair Labor Standards Act; employees are not eligible for overtime compensation.

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: R1038190