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US: Associate Sr., Clinical Research

Date: 16-Oct-2014
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Associate Sr., Clinical Research

Assists with the management and development of study related documents including clinical protocols, case report forms, study manuals, and other study related tools.

Reviews and approves site activation documentation.

Participates in site qualification and site initiation process, including scheduling of monitor activities with site personnel.

Assists in planning and preparing materials for investigator and coordinator meetings.

Assists in training of investigators and coordinators.

Tracks and reports progress of studies, e.g. subject screening and enrollment, data collection, documentation of adverse events.

Oversees activities by CROs.

Assists in query generation and resolution.

Provides input to study budgets and project plans.

Assists clinical manager by providing input to sections of the Investigational Plan, clinical reports, and abstracts/manuscripts.

Provides clinical scientific support to project teams.

Assists with core lab data management.

Assists with preparation of study summary reports for presentations, publications and regulatory submissions for FDA (510(K), IDE/PMA).

Assists with the development and implementation of site corrective actions as needed to address any noncompliance issues.

Assumes study management responsibility for smaller studies.

Has technical knowledge of medical device products.

Writes and/or provides input to the monitoring plan.

Your experience(s), education and knowledge will further expand St. Jude Medicalís marketplace success:

Bachelorís degree (technical or non-technical). Technical degree defined as engineering, biological sciences or related medical/scientific field.

5-7 yearsí experience directly supporting clinical research or similar experience in a medical/scientific area.

Masterís degree will substitute for 1 year of experience. A Ph.D. or MD will substitute for 2 years of experience.

High attention to detail and accuracy.

Advanced written and oral communications skills.

Able to manage multiple tasks.

Knowledge of clinical and outcomes research study design.

Proficient knowledge of medical terminology.

Expertise with GCPs, and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA).

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Thank you,
BioTech FYI Center