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Clinical Project Leader 3636 Rochester, NY Perm/Full $65,000 - $85,000

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Clinical Project Leader
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.
Qualifications Education: BA/BS, preferably in a scientific field, minimum. CRA Certification a plus.

Experience: At least two years experience managing clinical trials and clinical trial resources, or experience in a similar position that demonstrates project management experience.

At least four years experience as a medical device or pharmaceutical clinical research monitor (or equivalent), with both in-house and field monitoring background in a related industry, CRO or Medical Device/Pharmaceutical company.

Knowledge and understanding of current regulatory issues related to Phase I-IV clinical research. Must have working knowledge of FDA, ICH, and GCP guidelines. Knowledge of project management tools and practices. Ability to understand and review detailed clinical reports. Excellent communication and organizational skills. Comprehensive knowledge of Microsoft Word, Excel, and Powerpoint.

Special Skills: Ability to multi-task, determine priorities and move between various tasks independently.

Specialized Training: Courses in Clinical Research Monitoring; CRA Certification