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Clinical Research Associate
Ref No.: 15-04038
Location: Pleasanton, California
To liaise between various Medical and Scientific Affairs Department to manage resource, budget and timeline for studies
To coordinate and execute clinical research activities for multisite clinical studies

Scope
Support the post-launch evaluation of RMD products

Description of Responsibilities;

Clinical Research Associate

Works under general supervision, and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
Receives general instructions; plans and prepares studies.
Travels to field sites to monitor studies.
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
Monitors the sites and provides technical assistance, as necessary.
Works with Data Management and Biostatistical staff on the design of documents and processes for the collection of study data from participating sites.
Assumes accountability for the collection and maintenance of regulatory documentation, as applicable.
Assists with the coordination of training and certification of study site personnel.
With guidance, ensures accurate and complete study management/data collection and transfer into the data management system.
Ensures site compliance with regulations and study protocol.
Manages material logistics for the studies.
Conducts reference material testing in-house.
Supports the organization of investigator meetings, as necessary.
Makes sound recommendations to solve problems
Establishes, as appropriate, internal/cross-functional/customer relationships.
Uses discretion and independent judgement to recommend solutions to basic problems that the individual or team projects.
Assists, prepares and manages study timelines.
Participates in Project Team Meetings.
Keeps informed of trends and developments in clinical research.
Knows and effectively uses the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity.
Analyzes alternative approaches to solve problems or devleop new perspectives on existing solutons.

Typically requires 2-6 years relevant work experience, 4-6 years preferred.
B.S. or M.S. in Biology, Chemistry, Molecular Biology or related discipline.