LOCATION:  New York State
SALARY:  85k

Independently manage and monitor all aspects of implementation of pharmaceutical clinical studies in accordance with FDA regulations, and ICH and GCP guidelines for clinical research studies and SOPs.

Job Duties:
Assume project management responsibilities for clinical sites as well as field CRAs assigned to projects as needed and required by GCP.
Assume on-site and in-house monitoring responsibilities as needed and required by GCP.
Contribute to clinical research study design, quality assurance, data management, and reporting activities.
Identify and evaluate issues related to the project and implements resolutions.
Provide input on departmental decisions related to process and procedures.
Plan and create presentations of clinical research study information.
Participate in design and development of CRFs.
Project planning, budgeting, and expense analysis.
Participate in Investigator recruitment and provide final recommendation.

Requirements
•    BA/BS, preferably in a scientific field, minimum. CRA Certification a plus.
•    At least two years experience managing clinical trials and clinical trial resources, or experience in a              similar position that demonstrates project management experience.

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