- Seeks current information and maintains current knowledge base to analyze and interpret applicable regulations (federal and local laws, guidance, ICH-GCP, Revised Common Rule, 46 CFR 46, standards for accreditation, etc.)
- Align and amend research quality standards to institutional policies and procedures.
- Assists with development of new SOPs and reviews and provides revisions of current research SOPs as needed.
- Reviews the collection and documentation of data from clinical trial patient visits.
- Evaluates study protocols, informed consent forms, and other essential documents to ensure compliance with regulatory requirements and site standards
- Conducts regular audits to identify potential deviations from study protocol in compliance with local, state, and federal regulations.
- Exercises appropriate judgement in evaluating audit findings while reporting regular updates of non-compliance of all severities to supervisor.
- Prepares quality management reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.
- Assists in resolving quality issues and ensures that responses with corrective and preventative action plans are implemented in a timely manner.
- Validates continued maintenance of corrective action plans.
- Provides recommendations for continuous quality improvement including the development of verbal or written instructions.
- Collaborates with cross-functional teams, including researchers, sponsor/CRO quality assurance, Physicians, clinical staff, and leadership to implement quality improvement initiatives.
- Assists with compliance and quality assurance issues and supports external regulatory site visits, providing regulatory input to minimize potential for non-compliance findings.
- Develops and maintains quality assessment standards, tools, and procedures to conduct internal audits.
- Prepares and provides quality compliance plan in sponsor-based or federal-based audits.
- Works closely with clinical trials program structure related to training and operational functions to ensure quality assurance measures are being met by the research team staff.
- Performs other duties as assigned.
- Bachelor's degree in a scientific discipline or related field; OR equivalent combination of education and experience.
- Master's degree preferred.
- Minimum 3-5 years of experience in clinical research quality assurance or related role within healthcare, pharmaceutical, industry.
- Experience conducting audits and assessments in a clinical research setting.
- Thorough understanding of regulatory requirements and guidelines (e.g., GCP, ICH, FDA regulations).
- Demonstrate working knowledge of Quality Assurance and Quality Control procedures in a clinical research environment.
- Demonstrate technical competency, knowledge, and ability to analyze, plan and support QA/QC programs and services.
- Knowledge of clinical research methodologies, protocols, and regulatory requirements.
- Strong attention to detail and analytical skills.
- Proficiency in interpreting and applying regulatory guidelines.
- Excellent communication and interpersonal skills for effective collaboration with diverse teams.
- Ability to work independently, prioritize tasks, and manage multiple projects simultaneously.
- Proficient in utilizing various software tools and databases for documentation and data analysis.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, or schedule form.
- Must interact and communicate both verbally and in written form.
- Must interact and exchange information regarding patients with physicians and other departmental personnel, and outside agencies on a frequent basis while respecting the confidentiality of patient information.
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Research Quality Compliance Specialist - Little Rock, United States - CARTI
Description
JOB SUMMARY:
The Quality Compliance Specialist is responsible for ensuring adherence to regulatory standards, procedural compliance, and the maintenance of quality systems within the Research department. This role conducts audits, develops quality metrics, and collaborates with cross-functional teams to maintain and improve the integrity and compliance of our research studies.
SPECIFIC JOB DUTIES AND RESPONSIBILITES:
EDUCATION, CERTIFICATION, LICENSURE, REGISTRATION:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to talk or hear.
The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
Specific vision abilities required by this job include close vision and the ability to adjust focus.
WORK ENVIRONMENT:
The work environment described here are representative of those an employee encounters while performing the essential functions of this job. This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.
COMMENTS:
This description is intended to describe the essential job functions, the general supplemental functions and the essential requirements for the performance of the job. It is not an exhaustive list of all duties, responsibilities and requirements of a person so classified. Other functions may be assigned and management retains the right to add or change the duties at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the job.
SAFETY SENSITIVE
This position is a Safety Sensitive Position. The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.
