General Summary of Responsibilities:
The Senior Clinical Research Specialist (SCRS) will work with a sponsoring company or CRO in the execution of a pharmaceutical, device, or biologics trial with an emphasis placed on ensuring the highest ethical and clinical standards.
The SCRS possesses the ability to effectively prioritize and proactively manage multiple and varied tasks with enthusiasm. The SCRS employs a client-focused approach to work and a flexible attitude with respect to work assignments and new learning opportunities. By the nature of the position, the SCRS could be called upon in various situations to adjust to the changing needs of the company in any clinical area, including auditing, monitoring, training, project management, or consulting.
- Bachelor's Degree and a minimum of 10 years of Clinical Research experience. Strong working knowledge of Federal Regulations, ISO 14155, ICH-GCP
- Project Management and/or GCP Auditing experience preferred
- Professional verbal and written communication skills including the ability to effectively communicate with internal and external customers, third party vendors and strategic partners
- Demonstrates above-average decision making, problem solving and time management skills
- Ability to prioritize workload with critical thinking and attention to detail
- Demonstrates a willingness to work in and value a team environment
- Possesses negotiation, diplomacy, team leadership skills and organizational ability
- Prioritizes effectively and responds to urgent requests within team or from sponsor
- Computer proficiency, including the use of standard software (word processing, databases, e-mail) and the use of the Internet
Responsibilities that the SCRS could be called upon to perform include the following:
- Provide leadership and direction to project teams; support Clinical Operations in any department.
- Specific expectations are:
- Conduct clinical GCP audits
- Perform Project Management duties on various types of clinical projects
- Provide GCP training sessions, both internally and externally
- Provide consultative work for Quality System development (drafting SOPs, developing clinical strategies, etc.)
Support Quality System Activities:
- Understand and communicate the Quality Policy
- Support the company's Quality Management System and contribute to continuous improvement activities
- Train on controlled documents and maintain required records according to job responsibilities
- Participate in and/or conduct internal audits
- Support activities related to ISO certification
Approximately 25% of travel required
If you're interested in a career with IMARC, please send your resume to firstname.lastname@example.org.
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