Senior Clinical Research Associate, Dermatology (Home-Based, East Coast) - IQVIA Biotech (R1081116) in Morrisville, NC at IQVIA™

Date Posted: 6/22/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Date Posted:
    6/22/2019
  • Job ID:
    R1081116

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.

IQVIA Biotech is seeking Senior Clinical Research Associates, Dermatology (Home-Based, East Coast). 2 years prior dermatology monitoring experience required; psoriasis or atopic dermatitis experience strongly preferred:

SENIOR CRA ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
• Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
• Collaborates with the ISSC department to coordinate activities with the site in preparation for the initiation of the study. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with ISSC and site staff to obtain regulatory (IRB/IEC) approval of study specific documents
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
• Trains site staff on the EDC system and verifies site computer system.
• Assists in resolving any issues in order to ensure compliance with site file audits in conjunction with ISSC.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters per the timelines defined in Novella SOPs by using approved Novella/sponsor templates and reports.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
• Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Authorized to request site audits due to data integrity concerns.
• Attends study-related, company, departmental, and external meetings, as required.
• Ensures internal and study-related trainings are completed per Novella and/or study timelines; CTMS should be current at all times with the pertinent site updates/contacts.
• Ensures all study deliverables are completed per Novella and study timelines
• Conducts Field Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs.
• Serves as mentor for junior CRAs and those new to the company and/or study.
• Performs other duties, as requested

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™

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: R1081116