CLINICAL TRIALS OF TEXAS, LLC
Job Description
Job Title: QA Specialist I
Department: Regulatory & QA Compliance FLSA Classification: Exempt I. PURPOSE: To assist with oversight of quality operations for Clinical Trials of Texas, LLC (CTT). Work with Regulatory & QA Manager, Senior V.P., Operations, other managers and CRCs to define and create procedures, train, and implement CTT standards into clinical studies. Take a leadership role and work with Regulatory & QA Manager on projects to enhance continuous quality assessment improvement operations. Monitor progression and implementation of assigned quality projects. Review of study protocols, development, approval and implementation of study start-up, ongoing study conduct, closeout and archiving at study end. Assist in management and oversight of QA audit and Corrective and Preventive Action (CAPA) processes.
II. JOB RELATIONSHIPS:
Reports to: Regulatory & QA Manager
Senior V.P., Operations
President/CEO
Workers Supervised: None
Interrelationships: Works closely with Regulatory & QA Manager, team leads, CRCs, QC and other staff, sponsors/contract research organizations (CRO’s) and Institutional Review Boards (IRBs). III. ESSENTIAL JOB FUNCTIONS:
A. Assure CTT’s compliance with sponsor/CRO protocols, applicable federal, state, and local regulations as well as policies to avoid any business interruptions;
B. Communicate all identified compliance and quality risks/issues to Regulatory & QA Manager. Responsibilities include protocol risk assessment, plan and conduct QA audits, implement CAPA processes when necessary;
C. Work with Regulatory & QA Manager to implement and monitor processes that ensure quality when adding new sponsors, sites and studies;
D. Perform QA audits to assess whether records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, CTT standard operating procedures (SOPs), protocols, and corporate polices, and implement CAPA processes as appropriate. Identify, document, and report deviations from regulations, protocols, and CTT SOPs to the Regulatory & QA Manager;
E. Maintain written records of all audits performed as required for team leads, study coordinators, department managers, Senior V.P., Operations;
F. Meet regularly with the Regulatory & QA Manager and Senior V.P., Operations to review any trends or issues at the site; G. Participate in preparation and review of study and regulatory files in preparation for sponsor site visits and regulatory inspections;
H. Assure that study files are well maintained, organized and complete;
I. Assist in creation, review and revision of SOPs and other quality and regulated manuals/processes (including source documents) to ensure compliance with Good Clinical Practice, Federal Regulations, and ICH Guidelines in all aspects of conducting clinical trials at CTT;
J. Assist in providing basic regulatory and quality training to CTT personnel;
K. Participate in collecting and reporting of quality metrics;
L. Stay abreast of all Federal Regulations and ICH Guidelines and CTT policy changes;
M. Attend CTT staff quality improvement and departmental meetings to assist with presentation of quality issue (QI) activities and dissemination of review information;
N. Assist in ensuring that all CTT employees have adequate training (protocol specific/non-protocol specific) and training documentation to perform duties assigned;
O. Perform other studies and research projects as assigned;
P. Perform duties in a safe manner.
IV. MINIMUM REQUIREMENTS:
Education: Bachelor’s degree with at least one year of relevant experience in clinical research and development, quality assurance, and quality systems. Or without a Bachelor’s degree but at least three (3) years of relevant experience in clinical research and development, quality assurance, and quality systems.
Experience: A. Minimum of 1-3+ years’ experience within the field of clinical or biological research.
Knowledge and Skills: A. Demonstrates core values & all skills set required;
B. Must have a strong clinical background/understanding in Good Clinical Practices, protection of human research participants, development and implementation of clinical research standards and procedures, process and quality improvement, and clinical research;
C. Must have the ability to understand medical terminology and research concepts, and be able to identify the need for improvements in CTT processes, SOPs, training etc.;
D. Must have ability to identify appropriate patient care, relate in a professional and knowledgeable manner to physicians, pharmaceutical sponsors/CROs, and IRBs;
E. Must have basic knowledge of computers, internet access, Word processing, Excel spreadsheets, Power Point, Outlook and MS project,
F. Able to adapt to various work environments, manage multiple priorities, meet deadlines, train employees on multiple new and old tasks and projects, exercise initiative, demonstrate sound judgement, attention to details and communicate effectively with others, participate in/attend required courses, conferences and various trainings;
G. Assists with key initiatives/process improvements in the department;
H. Assists with training company new hires;
I. Completes at least 80% of goals annually