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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.