[Remote] CT Scientific Affairs Senior Analyst

Note: The job is a remote job and is open to candidates in USA. Rochester Regional Health is looking for a Clinical Trials Scientific Affairs Senior Analyst to join their team. This role involves reviewing study protocols, coordinating testing methods, and serving as a subject matter expert while interfacing with various departments. The position is essential for ensuring timely responses to proposals and maintaining relationships with referral laboratories.

Responsibilities

• Investigate testing requirements within a clinical trial protocol and help determine testing facilities to identify required testing and associated nuances for the timely and accurate response for proposals
• Review and prepare pricing documents, as needed, noting and correcting any discrepancies
• Maintain relationships between ACM and referral laboratories
• Provide scientific/ technical information to compile client RFP’s and RFI’s
• Provide feedback to the manager to address analytical trends or issues, to support business needs
• Assist in coordinating the testing methods with referral labs, as needed
• Obtain and document referred testing information throughout the course of the active trial, including contracting with referral labs
• Assumes responsibility for channeling information to and from Laboratory Operations and Sales
• Alert leadership to any issues during the life cycle of study related and testing needs
• Alert leadership to any issues with referral laboratories, assist with root cause analysis
• Suggests and helps implement improved work methods and ways to increase efficiency, reduce costs, and solve operational problems
• Liaison with internal and external partners and participate in client teleconferences to address new business needs or ongoing study issues
• Understands and follows company policies and procedures and respecting patient confidentiality
• Provide consultation to clinical trials operations and external clients, as needed
• Assist with training and guidance of new team members
• Works with leadership to update global SOPs, as needed
• Triage upcoming work and determine staffing capabilities and workload for assignments
• Serve as subject matter expert to internal and external clients
• Serve as escalation point for internal and external clients
• Assists in development, maintenance and updates to templates and tools
• Perform other duties as assigned

Skills

• Bachelor's Degree or 3+ years as a clinical laboratory scientist
• 3 years relevant laboratory experience
• 2 years clinical trials experience
• BS (Required)
• Strong interpersonal and communication skills
• Strong time management and organizational skills
• Ability to manage multiple projects with tight deadlines
• Ability to work independently and in a team setting
• Proficient in Microsoft Office
• Generalist laboratory experience
• Ability to lead and positively motivate others
• MT (ASCP) Certification - Preferred

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