Biodefense Regulated Laboratory Analyst at ClinicalRM
Posted in Other 16 days ago.
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Type: Full Time
Location: Frederick, Maryland
ClinicalRM is a full-service CRO specializing 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 an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ClinicalRM has a distinct ability to provide rapid response efforts to global health crises.
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.
* Support a variety of laboratory-based activities associated with FDA regulatory compliance, analytical method optimization & validation.
* Develop standard operating procedures (SOPs) study-specific procedures (SSP), etc. to ensure compliance with Good Laboratory Practices (GLP) regulation.
* Review protocols, study plans, and associated documentation to support research and development projects under GLP for products regulated by the Food and Drug Administration.
* Organize and tabulate laboratory records and resulting data to ensure complete study files.
* Analyze data and prepares reports for submission to FDA.
* Assist investigators to ensure that PI written reports are in compliance with appropriate standards, e.g., 21 CFR regulations.
* Assist principal investigators in developing documentation packages from laboratory studies that can support investigational and new drug applications (IND/NDA).
* Perform laboratory quality management activities for supported customers to the required quality standard, e.g., GLP. Supports analytical method validation studies to support use in FDA-regulated studies.
* Support medical or advanced animal research, including Animal Rule Studies, by assisting GLP compliant studies of investigational specimens from these studies, as an optional requirement.
* Support SIP Program by assisting GLP compliant studies for potency testing of clinical research materials.
* Support product release testing (potency, identity, stability) for cGMP manufactured materials.
* Ensure that integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials.
* Work in biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed), and meet requirements under the Army Personnel Reliability Program.
* Demonstrate knowledge in microbiology, laboratory sciences, and regulated laboratory requirements to perform the following specific tasks:
* Execute regulated studies as Principal Analyst, as required.
* Utilize techniques for protein quantification, antibody assays, and tissue culture assays.
* Tabulate, analyze and interpret data.
* Assist with animal manipulations i.e. handling, bleeding, minute volume measurements, assisting in necropsy, and isolation of tissues.
* 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.
Candidates for positions under CRM's contracts with the Department of Defense (DoD) may be required to pass one or more background/security investigations conducted by the DoD, U.S. Army, or other Federal Government agency.
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.
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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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.