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(Senior) Safety Coordinator (Home/Office-Based) - Novella Clinical (R1059603) in Morrisville, NC at IQVIA™

Date Posted: 1/11/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    1/11/2019
  • Job ID:
    R1059603

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.

BASIC FUNCTION:

Assists with delivery of Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and Novella SOPs and/or project specific procedures.  

Primary responsibilities include intake and triage of incoming safety events and related data.

Serves in a mentorship/leadership role which may include direct support of Safety Management Lead.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

  • Performs intake and triage of incoming safety events and related data including, but not limited to:
  • Monitoring and review of safety email box, safety fax and SAE hotline.
  • Printing of incoming documents.
  • Identifying and blinding all patient identifiers.
  • Identifying relevant study and event being reported, including determining if information is new information or follow-up to a previously reported event.
  • Creating new or locating existing case file.
  • Completing tracking of incoming documents.
  • May perform additional case processing tasks such as: Initial data entry into safety database, assembly of case documentation and submission to sponsor for pass-through studies.
  • Responsible for the initial set-up and ongoing maintenance of safety case files.
  • Assists Safety Management Lead with study start-up tasks including drafting case processing instructions and data entry guidelines.
  • Develops and maintains tracking reports related to progress of studies, including generating monthly reports as needed and communicating regularly with PVG Lead and team on status of activities.
  • Assists with SAE reconciliation as needed.
  • Assists with sending and following-up on outstanding queries.
  • Receives and documents incoming SAE hotline calls.
  • Prepares safety reports for submission to Sponsors, Regulatory Authorities or Investigators.
  • Performs study close-out and archival tasks.
  • Writes processes and develops documents related to intake/triage functions, including study-specific processes.
  • Provides mentorship to other Clinical Safety Associates.
  • Provides general administrative support to projects as requested (e.g., taking minutes, copying, filing, faxing, scheduling).
  • May mentor and/or train new Safety Management staff.
  • Performs other duties as assigned.

KNOWLEDGE, SKILLS AND ABILITIES:

  • Excellent written and verbal communication skills.
  • Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Safety Management department activities.
  • Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
  • Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
  • Basic knowledge of medical terminology.
  • Strong knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
  • Excellent time management skills.
  • Demonstrates professionalism and presents a positive image of the company.
  • Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.
  • Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.
  • Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
  • Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
  • Seeks input from others when faced with a difficult situation. Makes sound decisions within the scope of responsibility. Focuses on resolving problems rather than placing blame.
  • Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.
  • Demonstrates ability to serve in a mentorship/leadership role.

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

  • Very limited physical effort required to perform normal job duties

MINIMUM RECRUITMENT STANDARDS:

  • Bachelor’s Degree in one of the life sciences or clinical research and a minimum of 3 years of clinical trial safety experience required
  • Equivalent combination of relevant education and experience
  • Computer literacy and experience working with Microsoft Office (Word, Excel) required
  • Prior experience performing safety case data entry preferred
  • Prior experience with mentoring/training of staff preferred
  • Excellent verbal and written communication skills required. 
  • Excellent interpersonal and organizational skills required.
  • Ability to work independently, prioritize effectively and work in a matrix team environment required.

CLASSIFICATION:

This position is classified as non-exempt; 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: R1059603