Senior Specialist, Quality Control - Velocity Clinical Research, Inc.

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step.

As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity.

Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program.

Job Summary:

Conduct and manage QC of multiple sites with higher volume and complex studies in accordance with Quality Control Plan. Works closely with the clinical research coordinators and site directors to provide feedback on the quality of the source documents.

Duties/Responsibilities:

• Conduct QC reviews following current QC review processes or guidelines according to the quality control plan.
• Coordinate and conduct the quality review of source documents to identify protocol deviations, ALCOA-C and GCP/ICH compliance and logic checks.
• Review DOA log to ensure staff are delegated to the tasks for which they are documenting in the source.
• Lead or assist with QC special projects.
• Independently communicate study/regulatory/source documentation deficiencies to coordinators, investigators, and/or other responsible parties for resolution.
• Consistently identify compliance and deviation trends across coordinators and/or trials and escalate to Site Leadership, Investigator and Manager of QC.
• Consistently identify and escalate process gaps in Velocity SOPs to the Manager of QC.
• Communicate with Site Leadership and Velocity QA regarding any protocol deviations, good documentation practices deficiencies and any identified potential staff training requirements. This role emphasizes individual site trends analysis and thorough review of site-specific source documentation.
• Advanced ability to communicate effectively and professionally with coworkers and leadership.
• Perform QC duties while maintaining confidentiality and privacy.
• Identify/escalate issues regarding breaches of confidentiality of patient-protected health information, sponsor confidential information and/or Velocity confidential information.
• Advanced understanding of protocol requirements to identify potential areas of risk and assess for good documentation practices, and completeness of source.
• Lead site director quality calls to discuss QC findings.
• Maintain up to date quality reporting and tracking documentation.
• Mentor and train Quality Control Specialist I and Quality Control Specialist II as well as serve subject matter expert for coordinators.
• Other duties as assigned.

Required Skills/Abilities:

• Advanced problem-solving and strategic decision-making abilities.
• Advanced knowledge of GCP and ICH guidelines.
• Accepts individual responsibility for actions and demonstrates professionalism in feedback scenarios.
• Advanced understanding of medical terminology.
• Proficiency in utilizing various technologies: Computers, Microsoft Office, CTMS systems, Electronic Data Capture, Electronic Informed Consent systems, Electronic Regulatory Systems, fax, copier, and multi-line telephone.
• Advanced ability to work in a fast-paced environment.
• Strong verbal, written, and organizational skills.
• Strong interpersonal and communication abilities.
• Ability to work as a team player.
• Advanced ability to read, write, and speak English.
• Ability to multi-task.
• Ability to work independently, plan, and prioritize multiple deliverables and objectives with minimal guidance.
• Easily adapts to rapidly changing daily schedule and assignments.
• Advanced ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised.
• Must be detail-oriented.
• Capable of traveling up to 10%, as needed for on-site QC activities and other meetings as required.

Education and Experience:

• Bachelor’s degree and a minimum of 4 years’ experience as a Clinical Research Coordinator/Clinical Research Associate OR
• Associate degree and a minimum of 6 years’ experience as a Clinical Research Coordinator/Clinical Research Associate OR
• High School Graduate and/or technical degree and 8 years as a Clinical Research Coordinator/Clinical Research Associate

Required Licenses/Certifications:

• CCRC, CCRP, CCRA certification through ACRP or SOCRA, encouraged.

Physical Requirements:

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required.  Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change.  All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.