- 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.
- Communicate study/regulatory/source documentation deficiencies to Coordinators, investigators, and/or other responsible parties for resolution.
- Identify compliance and deviation trends across coordinators and/or trials and escalate to Site Leadership, Investigator and Manager of QC.
- Identify and escalate process gaps in Velocity SOPs to the Manager of QC.
- Works closely with QC manager to 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.
- Communicate effectively and professionally with coworkers, 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.
- Comprehend protocol requirements to verify good documentation practices, and completeness of source.
- Participate in site director quality calls to discuss QC findings.
- Maintain up-to-date quality reporting and tracking documentation.
- Act as resource for Quality Control Specialist I as well as serve subject matter expert for coordinators.
- Other duties as assigned.
- Proficient problem-solving and strategic decision-making abilities.
- Proficient knowledge of GCP and ICH guidelines.
- Proficiency in taking individual responsibility for actions and demonstrating professionalism in feedback scenarios.
- Proficient 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.
- Proficient 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.
- Ability to be flexible/adapt as daily schedule may change rapidly.
- Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued, and/or praised
- Must be detail-oriented.
- Bachelors degree and minimum of 2 years experience as a Clinical Research Coordinator/Clinical Research Associate OR
- Associates degree and a minimum of 4 years experience as a Clinical Research Coordinator/Clinical Research Associate OR
- High School Graduate and/or technical degree and 6 years as a Clinical Research Coordinator/Clinical Research Associate
- CCRC, CCRP, CCRA certification through ACRP or SOCRA, strongly encouraged.
- Prolonged periods of sitting at a desk and working on a computer.
- Must be able to lift up to 15 pounds at times.
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Specialist II, Quality Control - Beachwood, United States - Velocity Clinical Research, Inc.
Description
Overview:
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 complexity of 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.
Responsibilities:Duties/Responsibilities:
Required Skills/Abilities:
Education and Experience:
Required Licenses/Certifications:
Physical Requirements:
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.
