Clinical Quality Assurance Specialist (Danville)

The Emmes Company, LLC in Danville, VA

  • Industry: Scientific Research - Health/Medicine/Pharmacology
  • Type: Full Time
position filled
The Emmes Company, LLC is seeking a QA Specialist in our Rockville, MD, Frederick, MD, or Tysons, VA offices to support all phases of clinical trials.

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

CONNECT WITH US!!

Follow us on Twitter

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.
Associated topics: alcohol test, assistant, intern, internship, lab tech, lab technician, laboratory tech, qa, quality control, research associate

You may be interested in these similar jobs!
Pediatric Clinical Nurse Specialist Charlottesville, VA - Permanent/Full-Time (Danville)
Continuum Medical Staffing in Danville, VA

Pediatrics opening in , Virginia. This and other rn jobs brought to you by NursingJobCafe.comPediatric Clinical Nurse Specialist Charlottesville, VA …

Read More
Permanent Internal Medicine Physician in Virginia (Martinsville)
U.S. Army Medicine Civilian Corps in Martinsville, VA

Internal Medicine physician job in Virginia : Physician Internal Medicine: As a Physician (Internal Medicine), you will: / Provide first contact, con…

Read More
RN / Clinical Nurse Specialist / Virginia / Permanent / RN Needed in L (Danville)
One Stop Recruiting in Danville, VA

Good Day,My name is Terrell and we have a fantastic opportunity with a In-Home Health located around Loudoun County, Virginia. We are currently in ne…

Read More
Oncology Clinical Nurse Specialist - Charlottesville, VA - (Clinical N (Martinsville)
Continuum Medical Staffing in Martinsville, VA

Oncology Clinical Nurse Specialist - Charlottesville, VA - Academic/Teaching Facility Responsible for staff education for two inpatient oncology uni…

Read More
Oncology Clinical Nurse Specialist Charlottesville, VA - Permanent/Full-Time (South Boston)
Continuum Medical Staffing in South Boston, VA

Oncology opening in , Virginia. This and other clinical nurse specialist jobs brought to you by NursingJobCafe.comOncology Clinical Nurse Specialist …

Read More
Academic Clinical Educator Position / Work-Life Balance (South Boston)
Source Medical in South Boston, VA

Internal Medicine Physician needed in Danville, VA. Danville, VA / 2 Hours to Richmond, VA / Population of 42k Permanent, Full-time position (n…

Read More
Registered Nurse II Madison Heights and Danville, VA
Premier Staffing in Danville, VA

Premier Staffing Source, Inc. is seeking one, possibly two (2) Registered Nurses for a short-term assignment in the Madison Heights and Danville area…

Read More
Senior FedRAMP Risk and Compliance Specialist (Martinsville)
QUALYS in Martinsville, VA

What You'll Need:Due to the requirements of the FedRAMP program all candidates MUST be a US Citizen located within the United States.5-10 Years direc…

Read More
PACT RN, Support Specialist
Danville Pittsylvania Community Services in Danville, VA

Danville Pittsylvania Community Services Behavioral Health Services DivisionPACT Registered Nurse Annual Salary Range: $43,560 - $68,608Sign-on Bonus…

Read More
Occupational Therapist - PRN
Bluegrass Community Hospital in Danville, VA

SOVAH Health - Danville Description Provides occupational therapy services to patients needing to develop, recover and maintain occupational s…

Read More