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Quality Supervisor, Clinical Trials

Company: Icon Government and Public Health Solutions
Location: Silver Spring
Posted on: February 14, 2019

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.

DETAILED 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.

* Implement and maintain a viable internal quality compliance function for all activities within the CTC; both daily quality compliance and periodic quality assurance (protocols and lab area).2.

* Protocol specific:

* Review to develop an internal monitoring plan that is appropriate for phase, complexity, and size of the trial.

* Review protocol specific source forms; subject, lab and investigational product prior to use. Discuss deficiencies with internal staff and recommend modifications, as needed

* Review documentation of ongoing studies for accuracy and completeness.

* Document deficiencies constructively as queries for the coordinators and investigators. Provide educational recommendations and references when appropriate to improve study implementation practices.

* Review responses to queries to ensure that corrections are complete and appropriate.

* Review and assure study Regulatory Files are maintained and complete in accordance with applicable regulations and guidelines.

* Facilitate communication between CTC and other quality groups.

* Contribute to external audits and inspections when appropriate.

* Maintain and develop SOPs (standard operating procedure), in collaboration with other team members

* Recommend appropriate staff training.

* Maintain tracking document for all studies conducted at the CTC through time of transfer to the WRAIR

* Archivist (or Sponsor) to off-site location.

* Participate in other aspects of conducting clinical trials within CTC if required. Participate in other aspects of conducting clinical trials within CTC if required.

* Maintain professional growth with updated and advanced courses.

* Maintain a safe workplace ensuring that he/she is aware of and observes appropriate saftety 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.

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.

GENERAL INFORMATION:

The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be an exhaustive list of all duties, responsibilities, and skills required.

The employee must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple, competing tasks and demands and to seek supervisory assistance as appropriate

EqualOpportunityEmployerDescription

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

PayTransparencyPolicyStatement

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor s legal duty to furnish information.

Keywords: Icon Government and Public Health Solutions, Silver Spring , Quality Supervisor, Clinical Trials, Healthcare , Silver Spring, Maryland

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