KEY SKILLS & BEHAVIORS
− Extensive knowledge of clinical monitoring and applicable regulatory requirements
− Attention to detail and a methodical approach to work
− Strong interpersonal skills, an ability to communicate at all levels and provide support for less experienced CRAs
− A proven ability to organize, take initiative and follow−up independently
TRAINING AND EXPERIENCE
− Degree (life sciences preferred)/ Registered Nurse / Equivalent Fluent in the English language and local languages as required for the
performance of source data verification
− Minimum of 3−4 years clinical research experience In depth knowledge of ICH−GCP and applicable regulatory guidelines
− Ability to travel up to 60% of the time
− Fluent in English and local language.
The primary function of a Senior Clinical Research Associate (SCRA)is to ensure the timely production of high quality data, adhering to
the standards set by the Company/Sponsor in the Standard Operating Procedures for clinical studies.
− Identification of potential investigational sites
− Coordinates and performs comprehensive site management
− Conduct of pre−study, initiation, interim and close out monitoring visits
− Produces comprehensive visit reports and status reports
− Resolves data issues and audit issues
− Adherence to the study timelines and budget
− Mentors less experienced CRAs
− Within International (when applicable)− collects high quality essential documents and supports completion of ethics committee and
regulatory submissions in association with the respective departments in Theorem Clinical Research.
− Completes all other assignments given by management or as business needs require.
− Within Europe – when applicable, the collection of high quality essential documents and completion of ethics committee and regulatory
submissions in association with Clinical Services Centre
Theorem Clinical Research - 17 months ago
Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...