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Clinical Compliance Specialist
Location: Northeast

Key Functions:

Plan and conduct scheduled corporate clinical audits to assess compliance with FDA, international and internal requirements. To include audit scheduling, investigation, and evaluation of audit observations and findings, reporting, follow-up, and confirmation of follow-up actions.
Plan and conduct requested audits of specific trials, processes, or sites. To include investigation, evaluation, and confirmation of follow-up. Participate in planning, coordinating, and implementing of corporate clinical auditing policies. To include review of GCP regulations and current FDA and non-U.S. requirements and
incorporation into internal programs where appropriate.  Review, understand, and implement changes related to regulatory changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, and training programs.
Participation with Corporate and Divisional Clinical groups on policy/procedure/guideline
development. Includes generation, review, and implementation of these documents.

Position Requirements:

Bachelor’s degree or equivalent based on prior work experience.

Compliance auditing experience in a pharmaceutical, medical device or comparable environment.

Knowledge of human anatomy and physiology desired.

Comprehensive working knowledge of FDA regulations and guidelines (QSR, 510(k), PMA, IDE requirements) or comparable audit requirements and guidelines.

A minimum of three to five years experience of conducting or participating in clinical trial evaluation in the pharmaceutical, medical device industry or comparable environment.

50% travel is required.