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Senior Clinical Research
Associate
Minnesota
SUMMARY
We are seeking an experienced clinical research professional to assist in project
management of worldwide clinical investigations. The Sr. Clinical Research Associate is responsible for managing and meeting
milestones and compliance with regulatory and department standards. This role works proactively and independently.
RESPONSIBILITIES - Assist in the planning, execution, and management of clinical
study programs and clinical study reporting
- Provide guidance to study monitors to ensure successful
execution and conduct of clinical monitoring activities while ensuring compliance and proper documentation and resolution
of monitoring issues and action items
- Manage Clinical Events Committee meetings and facilitate
the collection of patient information for review by the committee
- Research and write adverse
event and patient death summaries
- Facilitate tasks to ensure that clinical project timelines
are met and deliverables are on schedule
- Identify and implement process improvements and ensure
staff compliance
- Determine obstacles, identify solutions, and implement plans to meet study
milestones
- Develop and maintain study progress status reports
- Work
with cross-functional interdepartmental groups as necessary
- Generate research site activation
and training materials
- Other duties as assigned
QUALIFICATIONS
Bachelors degree in
life science or scientific/healthcare or related field and a minimum of 5 years experience in monitoring of clinical trials
and clinical research studies; 2 years of experience providing work direction and leadership to people and teams. A qualified
candidate has experience with the following: - Proficient
knowledge of IDE regulations and GCP/ICH guidelines
- Develop and write monitoring plans, corrective
action plans, and SOPs as needed
- Conduct research site training and communicate compliance
concerns
- Review all monitoring action items and address their resolution
- Collection patient-specific information from research sites and complete written AE/Death Summaries
- Review of research site consent documents to ensure compliance with regulations, IRB and sponsor requirements
- Demonstrate ability to clearly and effectively communicating verbally and in writing
- High
attention to detail and accuracy and ability to creatively solve problems
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