Clinical Services Associate jobs in the United States

Job Description

Senior CRA

Responsibilities include:

* All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties

* All aspects of site and registry management as prescribed in the project plans

* Organize and make presentations at Investigator Meetings

* Report, write narratives and follow-up on serious adverse events

* Review progress of projects and initiate appropriate actions to achieve target objectives

* You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required

* Participate in the development of protocols and Case Report Forms as assigned

* Interact with internal work groups to evaluate needs, resources and timelines

Qualifications

* 5 years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment

* Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines

* Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas

* Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process

* Good planning, organization and problem solving abilities

* Good communication and interpersonal skills

Additional Information

All your information will be kept confidential according to EEO guidelines.