Sr. Clinic Research QA Monitor

The Senior Clinical Research Quality Assurance Monitor will assess research participant safety, data integrity and research compliance with applicable institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance. Job tasks include ensuring compliance with all Institutional Review Board (IRB), FDA and other study regulatory requirements and completeness of study documentation; reviewing research data with source documentation for accuracy, completeness and integrity; performing investigational product review and accountability. The individual will serve as a regulatory affairs and compliance resource to CETI, CCIR, providing support to junior Quality Assurance coordinators. Under the guidance of the Clinical Research Program Director, the Sr. Clinical Research Quality Coordinator will implement research quality assurance activities, and risk assessment and reduction strategies to ensure research compliance. Activities could include developing and revising monitoring plans, monitoring tools and standard operating procedures; organizing and delivering individual and group education programs; and other activities as assigned. The role requires at least three years substantive experience with Phase I though Phase III trials at the Clinical Research/Quality Assurance Coordinator, Source Data Verification Monitor, Research Compliance Specialist or IRB Reviewer level.

Qualifications - External

Minimum Education

Bachelor's Degree in scientific discipline or research. (Required)

Master's Degree (Preferred)

Minimum Work Experience

At least 5 years of experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject research. (Required)

Previous experience with investigator-initiated or pharma-sponsored clinical trials in one of the following capacities is strongly desired: lead research coordinator, program manager, clinical research monitor, regulatory coordinator or IRB reviewer (Preferred)

Required Certifications

Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP)

Required Skills/Knowledge

* Analytical, communication and organizational skills generally acquired through completion of a bachelor's degree program and experience reviewing, leading and/or overseeing clinical research.

* Ability to work well with diverse, goal-driven colleagues to achieve research compliance while minimizing administrative burden.

* Computer Skills -proficiency with Excel, Word, Outlook, Access, & PowerPoint; along with cloud-based electronic medical record and database programs.

Functional Accountabilities

Responsible Conduct for Research

* Demonstrates consistent adherence to the standards for responsible conduct of research.

* Complies with and maintains current documentation of all job-related certifications and training

* Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance documents.

Quality Assurance Program Monitoring

* Conducts research compliance audits within established program timeframes, in accordance with institutional standard operating procedures (SOP), Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations and guidance documents.

* Authors accurate, detailed audit reports that document compliance findings and provide regulatory citations.

* Follows up with auditees to ensure that audit responses and corrective and preventative action plans (CAPA) are provided in a timely manner, allowing for audit closure.

* Manages multiple, complex activities while maintaining close attention to detail and not losing sight of the institution's research mission.

* Demonstrates formal and informal leadership in a diverse professional environment.

* Collaborates with interdisciplinary teams to identify and resolve research compliance challenges.

* Presents negative information and provides compliance resources to stakeholders in a collegial and educational manner.

Educational Support and Training

* Stays informed of current institutional policies, federal regulations and guidance, and internal and external audit findings involving human subject research and the use of protected health information (PHI).

* Provides current and accurate compliance information and resources to the research community.

* Works well with research stakeholders, appreciating differing skill sets and other workplace diversities while seeking appropriate input.

* Attends meetings (which could include overnight travel) as requested.

* Provides information and services to assist with FDA inspection readiness.

Organizational Accountabilities

* Organizational Commitment/Identification

* Partner in the mission and upholds the core principles of the organization

* Committed to diversity and recognizes value of cultural/ ethnic differences

* Demonstrate personal and professional integrity

* Maintain confidentiality at all times

Customer Service

* Anticipate and responds to customer needs; follows up until needs are met

* Teamwork/Communication

* Demonstrate collaborative and respectful behavior

* Partner with all team members to achieve goals

* Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

* Contribute to a positive work environment

* Demonstrate flexibility and willingness to change

* Identify opportunities to improve clinical and administrative processes

* Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

* Use resources efficiently

* Search for less costly ways of doing things

Safety

* Speak up when team members appear to exhibit unsafe behavior or performance

* Continuously validate and verify information needed for decision making or documentation

* Stop in the face of uncertainty and takes time to resolve the situation

* Demonstrate accurate, clear and timely verbal and written communication

* Actively promote safety for patients, families, visitors and co-workers

* Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance