Note: The job is a remote job and is open to candidates in USA. Rochester Regional Health is seeking a Clinical Trials Scientific Affairs Senior Analyst who will be responsible for reviewing study protocols and facilitating timely responses for proposals. The role involves coordinating testing methods with various departments and serving as a subject matter expert within the team.

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
• 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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