Clinical Trial Associate (Office-Based) - IQVIA Biotech
Location: Rochelle Park, NJ, NJ
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.
The primary role of the Clinical Trial Associate position is to administer, maintain, and coordinate the logistical aspects of clinical trials in compliance with Good Clinical Practice (GCP) and relevant Standard Operating Procedures (SOPs) and Process Documents (PDs) and the Study Responsibilities Task List. Will act as a pivotal point of contact and support for the Project Management team. The Clinical Trial Associate may travel up to 30% to Project Management Team meetings or for other business related reasons.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Oversee clinical supplies and distribution to sites. Communicate with sites on issues escalation related to clinical supplies.
- Prepare, collect and provide support to sites on essential document collection and maintenance.
- Coordinate the set-up, organization, maintenance, and close-out of Trial Master Files (electronic and paper).
- Coordinate the quality control reviews (QC), final reconciliation and archival processes for study documents/plans and Trial Master File.
- Prepare and submit central IRB submissions and communicate with the IRB. Provide support to sites for site and local IRB submissions.
- Coordinate with Recruitment Management regarding advertising submissions to IRB.
- Prepare Drug Release Authorization forms and collect required documentation.
- Develop, data enter, and maintenance of study tracking databases/logs (i.e. Start-up, feasibility/site selection, Monitoring, vendor activities etc.)
- Coordinate tracking and uploading monitoring visit documents including Monitoring Visit Reports, confirmation/follow-up letters in TMF.
- Prepare materials (e.g., binders, agendas, meeting minutes) for Investigator Meetings (IM), Kick-Off Meetings (KOM), and Face to Face Meetings (FTF).
- Performs data entry into the CTMS system for study or client information.
- May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
- Perform administrative tasks to support team members with clinical trial execution as needed.
KNOWLEDGE, SKILLS AND ABILITIES:
- General knowledge of applicable clinical research development, regulatory requirements; including GCP and ICH guidelines and competent authority.
- Strong Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.
- Strong written and verbal communication skills.
- Effective time management and organizational skills.
- Attention to detail and accuracy in work
- Aptitude for handling and proofreading data.
- Strong customer service orientation.
- Ability for travel (e.g. Investigators Meetings)
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
- Very little physical effort required to perform normal job duties (unless otherwise indicated)
MINIMUM RECRUITMENT STANDARDS:
- College degree in any of the life sciences preferred, or with a certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- ≥ 2 years’ experience with Novella Clinical or working within the health sciences field in a similar position.
This position is classified as exempt under the Fair Labor Standards Act.
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™
QVIA 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 [Click Here to Email Your Resumé] to arrange for such an accommodation.Job ID: