Clinical Quality Assurance Specialist

Company: The Emmes Company, LLC
Location: Rockville
Posted on: September 4, 2020

Job Description:

The Emmes Company, LLC is seeking a Clinical Quality Assurance Specialist based out of our Rockville, MD, Frederick, MD, or Tysons, VA offices to support all phases of clinical trials. Emmes provides flexibility for the office location or work remote preference dependent upon position. The Emmes Company, LLC established in 1977, is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance. Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation. Primary Purpose The QA Specialist will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations by conducting audits of Emmes projects, department, processes, and vendors used to support clinical trials. He/she will be responsible for assisting in various quality improvement initiatives in order to comply with Good Clinical Practice (GCP) and ICH requirements, SOPs, and applicable regulations. This individual will work closely with a Quality Assurance Manager in support of Emmes' corporate Quality Assurance Department. Primary Responsibilities Conduct internal audits to identify non-compliance in adherence to SOPs and regulations Provide GCP/QA consultation to Emmes staff Support regulatory/client audits Support supplier/vendor qualification and evaluation Support / lead quality and standardization initiatives Drive completion of quality compliance plans Write/revise SOPs, as needed Prepare Quality Management Reports Support quality improvement initiatives in order to comply with Good Clinical Practice (GCP) requirements, SOPs, applicable regulations, and promote quality Requirements BS degree and 2 years of clinical trial QA and auditing experience Certified Quality Auditor (ASQ-CQA, RQAP-GCP), ISO, CCRA, or equivalent certification preferred An in-depth knowledge and experience in the application of good clinical practice (GCP) requirements is required (eg, ICH, FDA, etc), as is familiarity with the essential documents related to clinical studies Experience in GCP auditing activities Thorough knowledge of ICH-GCP and appropriate regional clinical research regulations and guidelines Strong written and oral communication skills Ability to work with others as well as independently Ability to multi-task Excellent organizational and time management skills Enjoy working in a team environment Required Travel: Up to 25% to conduct vendor audits CONNECT WITH US Follow us on Twitter - EmmesCRO Find us on LinkedIn - The Emmes Company, LLC The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Keywords: The Emmes Company, LLC, Rockville , Clinical Quality Assurance Specialist, Other , Rockville, Maryland