Project Analyst - Clinical Trial Management System

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation’s oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.

All About You

JOB SUMMARY

This position is a key member of the Clinical Trial Management System support team and will support operations, management of research departments within the Advarra systems, subscription utilization, and regulatory compliance.

Open to a remote employee in any of the following states if not living in the Greater St. Louis area: Alabama, Arizona, California, Colorado, Illinois, Indiana, Kansas, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Rhode Island, Tennessee, Texas, Utah, Virginia, West Virginia or Wisconsin. ​

JOB DUTIES

CTMS Study Builds and Maintenance

• The primary role of this position will be assisting with the setup, build, activation, and ongoing support of all trial types (federally funded, industry-sponsored, and investigator initiated human subject research) in Clinical Conductor – SLU’s CTMS system.
• This involves reviewing clinical research protocol documents and replicating the protocol schedule of events and collaborating with direct supervisor, finance team, clinical research team, project manager, health system representatives, consultants, and vendors to ensure overall completion of goals, schedules, and deadline.
• Using approved documentation, analyst would also build and manage the lay language content in the CTMS that feeds into SLU’s clinical trial finder website and periodically reviewing study statuses to ensure that only currently enrolling studies appear on the website.
• Analyst would also update CTMS protocol information as amendments occur to the protocol calendar/ budget.

Regulatory System Builds and Maintenance

• This position also supports the eRegulatory (eReg) electronic regulatory binder system which involves managing contacts/user privileges, creating and updating binder templates, and maintaining central certification documents (laboratory, pharmacy, IRB, etc.) and current SOPs links within the system

QA/QC and Reporting

• Perform system testing as directed and quality control of application functionality during application upgrades.
• Helps to develop and build reports for CTO, business managers, SOM leadership.
• Assists with user training, as needed.
• Assists with auditing of each system to ensure minimum data requirements.

Site Support/Training

• Provide first line of technical support (help desk) to current users who encounter problems or have questions with CTMS electronic systems - include Advarra's Clinical Conductor and eReg, as well as any related interfaces with additional systems, and any future systems deployed to support the research mission.

Other duties as assigned.

REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES

• Excellent verbal and written communication skills.
• Excellent interpersonal and relationship building skills.
• Knowledge of business, budget, financial processes, practices, financial guidelines and terminology. Planning/organizational skills.
• Detail-oriented.
• Ability to exercise sound judgment in complex situations.
• Ability to work in a team environment.
• Strong analytical skills and proficient in business applications (Excel, Word, PowerPoint etc.). Great understanding of clinical trial related data.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Experience with Electronic Medical Records, such as EPIC.
• Understands SQL, advanced in Excel, SAS experience is a bonus.
• Experience with developing reports, stats and analyzing data to support report building.
• Ability to be self-directed, meet timelines, participate in meetings.
• Strong and effective communication skills are required.

MINIMUM QUALIFICATIONS

Meets one of the following:

• Bachelor’s degree or 5 years of related experience in clinical systems analysis, or
• Bachelor’s degree in a related field with experience in clinical research and clinical trial management systems, or
• RN with experience in clinical research and clinical trial management systems, or
• 5 years Business Analyst experience

ADDITIONAL INFORMATION

Clinical Conductor (the system used by the School of Medicine to manage clinical trails) is a suite of clinical and translational research modules consisting of software for research, patient registry and biospecimen management implemented in multi-disciplinary institutions, including NCI designated Cancer Centers.

Salary/Benefits

$65,960-$81,200

Pay will be determined based on amount of relevant experience. Pay also includes benefits including vacation and sick leave, health/dental/vision/life insurance, 403B retirement savings plan and match, tuition remission, employee assistance program and wellness program.

Function

Clinical Research

Scheduled Weekly Hours:

Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. We welcome and encourage applications from minorities, women, protected veterans, and individuals with disabilities (including disabled veterans). If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.