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Study Start-up Associate (Home/Office-Based) - Novella Clinical (R1053129) in Morrisville, NC at IQVIA™

Date Posted: 12/3/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    12/3/2018
  • Job ID:
    R1053129

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 ISSC Associates both home-based and office-based in Raleigh-Durham, NC

BASIC FUNCTIONS:

Responsible for 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 assure good communication, regarding documentation processing.  Assure documents maintained in ISSC are in compliance with International Congress on Harmonization-Good Clinical Practices (ICH-GCP), country regulatory requirements and procedures set forth by Novella and its clients.  An ISSC Associate II may be assigned to start-up or ongoing file maintenance projects, and typically is able to work independently on a project with minimal supervision.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

Start-Up:

  • Provides updates during weekly client teleconferences, client meetings, and internal team meetings.
  • Plays key role in the coordination of the development of the feasibility questionnaire for a study.  Reviews the protocol, seeks expertise from applicable supporting functions (CTM, Medical, PM, Contracts, Regulatory, etc.), and finalizes draft for Sponsor review.  Works with PM to obtain client approval of the study specific feasibility questionnaire.
  • May support ISSC Lead/Manager in working with client to obtain/agree to study specific Confidential Disclosure Agreement (CDAs) Template for a study.  
  • Distributes Confidential Disclosure Agreements (CDAs) and feasibility questionnaires to sites and follows up with sites accordingly to ascertain interest and to meet study timelines
  • Reviews and negotiates the CDAs according to country specific requirements, seeking legal/management review when required.
  • Sends regulatory packets to selected sites and documents/follows-up with sites on the start-up process at the site in order to obtain estimation of site’s time to open or estimated month for SIV.
  • Supports sites to answer any questions required for their local IRB/ethics committee submissions.
  • In North America, reviews and negotiates with sites on modified Informed Consent Form language; and follows up with sites and sponsors accordingly.
  • Contacts sites directly, or through local representative (country dependent), as required to resolve any questions the site may have before scientific committee, IRB/ethics committee submission and final review.
  • Collects and reviews essential regulatory documents required to activate a site according to the study specific Regulatory Management Plan.
  • Notifies Regulatory Affairs department when initial essential documents are available for review. Works with Regulatory Department to resolve any concerns.
  • Contributes to the development of site specific timelines for SIVs at the beginning of the study; and adheres to study timelines. 
  • Documents/escalates study challenges, and communicates updates to Project Manager and ISSC Lead/Management.
  • Maintains up to date and accurate tracking on the start-up status for each site in applicable system(s) for the study. 
  • Update study start up timeline tool, per Novella SOP.
  • Participates in reviewing Safety and Regulatory management plans.

Ongoing File Maintenance:

  • Reviews documents received from sites, IRBs and CRAs to ensure compliance with GCP and Novella’s standard operating procedures. 
  • Manages ongoing IRB/ethics continuing renewals, where applicable, and reviews investigator study files for expired documents.
  • Communicates directly with the site, or with local CRAs in various countries, to obtain corrections to incomplete/incorrect/expired documents.  Tracks any action items to CRAs/sites in CTMS.
  • Reviews eTMF reports on a regular basis to ensure all documents have been filed according to Novella SOPs.
  • Distribute and track protocol amendments and IRB/ethics approvals of the amendments, as required. 
  • Reviews changes to site specific ICFs as changes occur during the study, and negotiates language changes with the site/sponsor/study team.  Completes ICF checklists and files IRB approved ICFs throughout the study.  Maintains accurate and complete site specific ICF template tracking.
  • Distributes reportable expedited safety reports and cross reports to sites, as needed, and tracks and files reports in appropriate system(s).
  • Submit ongoing regulatory documents to clients as needed.
  • Follows the appropriate Novella and/or sponsor SOPs during conduct of the study.
  • Ensures all project documentation is appropriately filed per Novella SOPs, or Sponsor SOPs if required.
  • Supports internal and client audits of the Investigator Site Files.
  • Provides updates to ISSC manager on a regular basis, and communicates any out of scope activities.
  • Uploads final documents in eTMF.
  • Creates study specific template documents as per Novella SOP.
  • Performs other duties as required.

KNOWLEDGE, SKILLS & ABILITIES:

  • Good 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, assess and recommend specific solutions in clinical settings, and mentor entry level ISSC staff

MINIMUM RECRUITMENT STANDARDS:

  • BS/BA/BSc, or equivalent, with a minimum of 3 years direct regulatory document review and/or start-up 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 (US):

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: R1053129