Laulima Government Solutions is looking for a qualified Veterinary Medicine GLP Study Coordinator to support our customer in supporting their Quality Assurance division where there is independent quality assurance, quality review, FDA Good Laboratory Practice (GLP) training coordination, and regulated document control duties that impact requirements for FDA-regulated studies, non-FDA regulated studies.

The ideal candidate will have experience in Biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed) and BPRP certification or the ability to obtain it. Main responsibilities include supporting activities involving the organization, coordination, and completion of projects; overseeing all aspects of assigned projects; setting deadlines, assigning responsibilities, and monitoring project progress in terms of cost, schedule, performance, and risk. Candidate will also prepare reports for upper management regarding status of project. Candidate chosen will also perform the following tasks:

Description of Responsibilities

• Serve as GLP Study Coordinator on studies evaluating candidate medical countermeasures for microbial biothreat pathogens at biosafety levels including BSL-4. The contractor shall carry out regulated laboratory studies to ensure compliance with the FDA Good Laboratory Practices (GLP) regulation and support a variety of laboratory-based activities associated with FDA regulatory compliance
• Plan and accomplish goals, and assure the successful and timely completion of assigned projects
• Perform a variety of tasks. Works under general technical direction and oversight, engaging with leaders as needed to solve problems
• Apply analytical biochemistry methodologies to support GLP studies
• Conceptualize and design detailed study plans
• Prepare and manage the investigator's animal records to GLP standard
• Review all animal supporting data applicable to GLP studies to include room records, daily records, surgical records, environmental reports, and enrichment reports; ensure they are in investigator animal study records on a timely basis
• Tabulate, analyze and interpret data
• Assist with preparation of technical reports and manuscripts for publication
• Develop standard operating procedures (SOPs), study-specific procedures (SSP), data forms, etc.
• Review protocols, study plans, support agreements and associated documentation for GLP studies
• Participate in execution of laboratory and animal studies, to include non-human primate studies
• Organize and tabulate laboratory records and resulting data and analyze data to ensure complete study files
• Assist with preparation of reports for submission to FDA
• Work with Study Directors to ensure IACUC amendments and GLP addenda are completed in a timely manner and in agreement with each other as required
• Introduction of, familiarization with and utilization of an electronic records database as related to GLP studies including the ability to audit information
• Coordination with VMD procurement personnel to ensure animals are properly procured, health or other records are available and reviewed prior to arrival of animals, and animals meet basic specs such as weight and gender requirements
• Coordinate all GLP VMD related data calls with the VMD "Animal Laboratory Practices Specialist" and/or the "Biodefense Regulated Laboratory Quality Control Specialist" respectively
• Participate in pre-protocol and other study related meetings associated with GLP protocols. Assist investigators to ensure that PI-written reports are in compliance with appropriate FDA 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), as needed. Work effort can contribute to an array of FDA regulatory documents e.g., Master File, IND, NDA/PMA. Impart and share GLP knowledge through in-lab training and side-by-side work for the transmittal of regulatory concepts, practices, and procedures. Supports advanced animal research, including studies under the FDA Animal Rule, by assisting with execution in compliance with GLP. Ensure integrity of the data and the quality of all studies meets acceptable quality levels, to include tracking and storage of investigational materials
• Provide monthly progress reports in accordance with specific project timelines and deadlines.

Required Skills and Experience

• Experience in Biocontainment environments (i.e., BSL-2, -3, and BSL-4, as needed) and BPRP certification or the ability to obtain it.
• Desired: Familiarity with the standard concepts, practices, and procedures within the particular scientific or technical field being managed as well as demonstrating proven experience in project management.
• Desired: Initiative, interpersonal, written and oral communication skills, and the ability to work effectively in a team environment.

Degree/Education/Certification Requirements

• U.S citizenship
• At minimum, required to have a National Agency Check with Local Agency Checks and Credit Check (NAC w/ LAC and CC) background investigation
• Desired: Bachelor's degree in science related field

Desired: Minimum of eight (8) years total experience in science related field

The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, and Kupono Government Services. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.

Laulima Government Solutions is a fast growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 10 paid holidays. Laulima Government Solutions is proud to be an equal opportunity employer.

For additional information on Laulima Government Services please visit

We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions on the basis of race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please to request accommodation. We E-Verify all employees .