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My client an international company is currently looking for 3 Clinical research Associates (CRA) for a 6 month contract + extension.
One of them must speak Spanish or Portuguese with english.
The Second is Swedish or Danish English. The third techque or hungarian + english.
Duties Responsibilities:
· Manages distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File.
· Assists in planning, preparing, and distributing materials for investigator and coordinator meetings, and for study-related training.
· Assists with the development and/or maintenance of Clinical infrastructure such as the drafting or reviewing SOP’s and Work Instructions.
· Core Team Member – ensures supporting CRA’s and CTS’s are aware of specific study needs
· Provides Trial Operations metrics to project teams
· ICF – Trial / Site Specific Development (country and site customization), Negotiation and Coordinate Approval
· Site Selection – Send/Receive Site Selection documentation to sites
· Completion of Study Master File Index (SMFI)
· Documentation – Request / collection of relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator / site documentation, review and approval of subset of documents in CDC
· Manage Authorization to Enroll process
· Collaborating with BAA to maintain contact information and staff changes in CTMS
· Quarterly review of MUL
· Primary in-house point of contact for sites
· Provides on-call help for sites
· CSA / Budget negotiations and executions (including amendments)
· IRB/EC/CA registration, renewal and maintenance
· Coordinate with appropriate functions for content development of Trial Support Material Generation
· Study close-out activities
Skills:
Minimum Education Experience:
§ Bachelor's level degree or equivalent in health/science related field.
§ Experience in clinical trials is required.
§ Strong communication and computer skills are also required.
Competency Expectations:
§ Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task.
§ Must possess the ability to work and make independent decisions, understand complex medical information, and be able to take the initiative to contribute to projects and assignments.
§ Excellent organizational and time management skills.
§ To be successful in this position it is important to have working knowledge of regulatory guidelines (FDA/CFR; EN540/GCP), and medical terminology.