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Quality Assurance Coordinator

Company: Clinical Research Management
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

ICON Government and Public Health Solutions specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

ESSENTIAL FUNCTIONS:

Reasonable Accommodation Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

  • Assist in developing and maintaining internal quality compliance function for activities within the CTC; both daily compliance and periodic quality assurance (protocols and lab area)
  • Review protocols and assist in developing an internal plan that is appropriate for phase, complexity and size of trial.
  • Review protocol specific source forms: subject, lab and investigational product prior to use.
  • Review documentation of ongoing studies for accuracy and completeness.
  • Ensuring subject visits are conducted according to FDA regulation, ICH guidelines, and company SOPs.
  • Ensure adequate reporting/tracking of adverse events, protocol deviation, and subject status
  • Review study Regulatory Files to ensure they are maintained and complete in accordance with applicable regulations and guidelines.

  • Confirms data recorded on CRFs is accurate, complete, and verifiable against source documents.
  • Document deficiencies constructively as queries for the coordinators and investigators.
  • Review responses to queries to ensure corrections are complete and appropriate.
  • Assists with the development and/or review of study- related materials including protocols, informed consent forms, source documents etc.
  • Contribute to external audits and inspections when appropriate.
  • Assist in maintaining and developing SOPs and SSPs in collaboration with other team members.
  • Assist in maintaining documentation of all studies conducted and completed at the CTC through transfer to the WRAIR Archivist (or sponsor) to off-site location.
  • Recommend and assist with implementing staff training, in collaboration with the Clinic Manager.
  • Participate in other aspects of conducting clinical trials within the CTC, if required.
  • Maintain professional growth with updated and advanced courses.
  • Provide assistance to Icon GPHS Headquarters as needed on proposals within projects and provide assistance with all job-related progress reports/technical reports.
  • Maintain a safe workplace ensuring that he/she is aware of and observes appropriate safety and occupational health rules and regulations. Employee is required to attend safety training relative to his/her position and report any infractions of safety procedures to the facility Safety Officer.
  • Performs light duties and other related duties as required and assigned.
  • Demonstrated understanding of applicable ICH/GCP/FDA Guidelines and Regulations, and Standard Operating Procedures/Project Work Instructions
  • Strong written, oral, and interpersonal communication skills in English language (writing, speaking and comprehending) including proficient knowledge of medical terminology.
  • Strong organizational skills with attention to detail.
  • Must have excellent time management skills.
  • Must be self-motivated and have a positive attitude.
  • Able to work in a team environment; dependable; assumes responsibility and accepts, supports and positively facilitates change.
  • Excellent computer proficiency of Microsoft Office package including Word, Excel and Outlook. Ability to develop and apply efficient computer tools to carry out job function.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Keywords: Clinical Research Management, Silver Spring , Quality Assurance Coordinator, Other , Silver Spring, Maryland

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