Clinical Trials Scientific Affairs Senior Analyst

Job Title: Sr. Scientific Affairs Analyst
Department: Scientific Affairs

Location: Remote, United States

Hours Per Week: 40 hours
Schedule: Days, Monday – Friday

SUMMARY 
The Clinical Trials Scientific Affairs Pre Award Senior Analyst is responsible for the review of study protocols and investigating testing requirements to assist in facilitating the timely response for proposals. Coordinates the testing methods as needed with ACM Research & Development, ACM Laboratory and referral laboratory partners for study support and set up. This position will act as a link and interface between the laboratory and other departments; ie sales, proposals and project management. The CTSA Senior Analyst serves as a subject matter expert within the team, provides support with escalations and assists with team member training.
 

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.
   

REQUIRED QUALIFICATIONS

• Bachelor’s Degree or 3+ years as a clinical laboratory scientist
• 3 years relevant laboratory experience
• 2 years clinical trials experience

PREFERRED QUALIFICATIONS

• 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

EDUCATION:

LICENSES / CERTIFICATIONS: 

PHYSICAL REQUIREMENTS:

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.