Clinical Research Associate – INCResearch Australia Pty Ltd – Auckland

Introduction:
Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development. From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we’ve continued to improve what we do.

We are currently looking to strengthen our Clinical Monitoring team in New Zealand and are seeking a Senior CRA to join our team to be based in Auckland.

Essential Functions:
Communication – Maintains timely and effective communication among team members and site staff.  Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
Regulatory Documentation – Assures compliance with local regulations, Code of Federal Regulations (CFR)/International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Participates in TMF and on-site audits as requested. Responds to less complex findings without oversight and may require guidance to respond to more complex/serious findings. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
Monitoring – Responsible for site management and site staff performance including: monitors all types of clinical trials; participates in all types of site visits; assures compliance with all protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AEs)/Serious Adverse Events (SAEs) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits effective time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
Data Handling – Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
Reporting and Tracking – Completes and submits reports according to SOP/Works Instructions (WI) or Sponsor requirements requiring minimal revisions. Maintains awareness of key study performance indicators for own sites, e.g. Telephone Communications Reports, patient enrollment, and SAEs. Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.

Why choose us:
It takes skill and passion to develop medicines the way we do. Don’t worry – if you’ve got the passion part, we’ll help you develop the skills you need to enhance every aspect of your career in the clinical research industry.

We’ve got an attitude at INC: “Can do, I own it.”Absolutely everyone has ownership of what they do here. And because we’re given the freedom and responsibility to really own our projects, we can take them tonew levels. And that means we can take our careers wherever we want them, too.

“We were ranked “Top CRO” to work with in the CenterWatch2013 Investigative Site Relationship Survey (a biannual survey of over 2,000sites worldwide).”

What happens next:
If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity.

Seiji Miyaki

Talent Acquisition Specialist – INC Research

seiji.miyaki@incresearch.com

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