About Us
DLH delivers improved health and national security readiness solutions for federal programs through science research and development, systems engineering and integration, and digital transformation. Our experts in public health, performance evaluation, and health operations solve the complex problems faced by civilian and military customers alike by leveraging advanced tools – including digital transformation, artificial intelligence, data analytics, cloud enablement, modeling, and simulation, and more. With over 3,200 employees dedicated to the idea that "Your Mission is Our Passion," DLH brings a unique combination of government sector experience, proven methodology, and unwavering commitment to innovation to improve the lives of millions.
Overview
We are seeking an Quality Assurance Specialist to join our team.
Responsibilities
Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidance's, ICH -GCP, standards for accreditation, etc.). Provides current and accurate compliance information and resources to the program staff. Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.
Evaluates compliance by planning and performing monitoring activities (i.e., routine and for-cause audits) in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).
Documents detailed compliance findings and recommendations in a timely manner that allows for proper review and assessment of the risks identified. Exercises appropriate judgment in evaluating audit findings, assists in the development of CAPA plans, provides targeted education and resources for resolution. Assists teams in resolving issues and ensures responses and CAPAs are implemented in a timely manner.
Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.
Assists in the management of external audits by regulatory agencies or business partners. Provides information and services to help research with FDA inspection readiness.
Other job functions as assigned.
Qualifications
Bachelor's degree in a related field required. Master's degree preferred.
A minimum of 5 years' experience within Clinical Research.
Demonstrated knowledge of federal, state, and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subjects research (ICH-GCP, OHRP, FDA regulations).
Certification or eligibility to sit for Certification Exam in relevant area (Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP).
Excellent customer service, project management, and process improvement skills. Ability to take initiative, prioritize tasks to meet deadlines, produce results and cope with the inherent pressures. Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve quality issues.
Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills.
Ability to perform multiple tasks with a high level of accuracy and attention to detail.
Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical records, clinical databases etc).
Basic Compensati
on:
$70,000 - $80,000 yearly salary
The salary offered within this range will be based on the selected candidates' skills, experience, education, market data, and internal parity. DLH may offer other rewards that may include performance incentives and program-specific awards. An applicant's salary history will not be used to determine compensation.
Benefits:
DLH Corp offers our employees an excellent benefits package including - Personal Time Off (PTO), medical, dental, vision, supplemental life with AD&D, short and long-term disability, flexible spending accounts, parental leave, legal services and more. We want our employees to save for their future, therefore we offer a 401(k) Retirement Plan, which includes a matching component. DLH is dedicated to your career development, providing training to help drive success, with access to our best-in-class e-Learning suite for formal and informal learning, professional and technical certification preparation, and education assistance at accredited institutions.
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