Company: INC Research
Closing Date: 22 Dec 16
Salary (£): Negotiable
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.
We are currently seeking a CRA to support the contracted services and expectations of clinical studies assigned to the project team. Candidates should have a minimum of two years independent monitoring experience and have been responsible for managing CNS studies. This position is located in Italy and can be home based or office based in Saronno.
•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.
•Administrative - Prepares for and attends Investigator meetings. May attend Customer and Business Development meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings, clinical committees, and clinical training sessions according to the project communication, monitoring, and/or training plans.
•Degree in science/health care field or nursing degree or equivalent combined education and experience.
•Clinical research and independent field monitoring experience
•Thorough understanding of SOPs, WI, FDA, and local regulations as well as ICH GCP guidelines
•Experience in the CNS therapeutic area
•Strong organizational, documentation, presentation, and interpersonal skills as well as a willingness to work within a team-oriented environment
•Effective command of written and spoken local language, if not English, as well as English
•Ability to handle multiple tasks to meet deadlines in a dynamic environment. Must have valid, current driver's license and ability to secure corporate credit card. ACRP CCRA or equivalent certification/credentials strongly preferred.
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 to new levels. And that means we can take our careers wherever we want them, too.
“We were ranked “Top CRO” to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites 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.
INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
|Tel:||+36 1 489 48 56|
|Website:||Visit Our Web Site|
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