Clinical Research Molecular Scientist

Job Description

Job Description

Position Title: Clinical Research Molecular Scientist

Organization: DEFENSE HEALTH AGENCY (DHA) AIR FORCE MEDICAL SERVICE ENTERPRISE-WIDE TECHNICAL CLINICAL RESEARCH TEAM (TCRT) 59th Medical Wing (59 MDW)

Location: Joint Base San Antonio, TX

Position Type: Full-Time

Security Clearance: Public Trust

Summary:

Emerge Solutions Group, LLC (EMERGE) is seeking a Clinical Research Molecular Scientist to provide support to the 59 MDW located within the continental United States (CONUS) and throughout Joint Base San Antonio to include the Science and Technology Headquarters (ST HQ), Clinical Investigations and Research Support (CIRS), and Center for Advanced Molecular Detection (CAMD).

The ST HQ mission is to conduct clinical studies and translational research and apply knowledge gained to enhance performance, protect the force, and advance medical care and capabilities across the global health system. ST HQ continues to facilitate development of innovations for advancing the care and rehabilitation of the combat wounded and support for Food and Drug Administration (FDA) regulated trials supporting activities Enterprise-Wide. In order to support the required research, the ST HQ office requires support from a Technical Clinical Research Team (TCRT).

Duties and Responsibilities:

• Be experienced and qualified to do research testing in the field of Molecular Laboratory Science to include but not limited to nucleic acid extraction and quantification, electrophoresis, PCR, rtPCR, Microarray, and Sequencing. Familiarity with various Sequencing techniques to include Pyro-Sequencing, Sanger Sequencing and Next Generation Sequencing (NGS). Experience with multiple library preparation techniques for transcriptome,exome and whole genome NGS.
• Develop methods related to their particular field of expertise to support research protocols approved by regulatory oversight committees. Methods must be developed to meet researchers' needs and be in compliance with Good Laboratory Practice Guidelines. Be able to develop test methods and implement testing independently.
• Perform manual and automated testing on multiple body fluids from human research subjects and various species of animal subjects as described in approved research protocols.
• Perform all required setup and quality control and quality assurance processes required for equipment used in analyzing specimens for research purposes. Meet all accreditation requirements for Good Laboratory Practices in using manual and automated testing equipment.
• Analyze the results of tests and experiments to ensure conformity to specifications, using special mechanical and electrical devices.
• Review results of tests and quality control materials to ensure that testing processes were in control and all data produced is accurate and precise.
• Analyze and record test data to issue reports that use charts,graphs and narratives.
• Enter data into various computer systems to meet research protocol requirements. Follow established procedures invalidating and verifying data entered in to computer systems.
• Use standard laboratory techniques and follow operating instructions in preparing materials for test procedures (i.e., standards, calibrators, solutions, and reagents). Use standard laboratory procedures to prepare specimens for molecular, chemical or toxicological analysis.
• Process and ship all samples according to regulations and protocol requirements.
• Document all correspondence and communication pertinent to the research.
• Assist in the preparation and analysis of laboratory experiments, as requested.
• Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.).
• Manage study documentation to include accurate and timely filing.
• Adheres to Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), International Air Transport Association (IATA), Good Laboratory Practices (GLP) and infection control procedures.
• Assist in writing method validations, operating procedures, presentations, and publications using provided methodologies and formats.
• Collect and process specimens from research subjects for testing purposes. All specimens must be collected, processed and handled as described in approved research protocols.
• Assists the PI to refine the specific laboratory requirements to meet the aims, research questions, hypotheses, and/or objectives of the studies.
• Conducts laboratory procedures and testing in accordance with the approved protocol. Performs appropriate study specific procedures as outlined in the protocol.Orders study materials, equipment, and/or supplies as specified in the research protocol and in accordance with Clinical Research Division (CRD) policies.
• Maintains all protocol binder to include all approved protocols and amendments and all data obtained from laboratory procedures.
• Abstracts required research data elements from paper or electronic systems or other existing documents, clinical computer databases such as the AHLTA, CHCS or JPTA, and/or other electronic diagnostic reports in accordance with the research protocol and enter these data into spreadsheets, databases, and/or statistic software as required.
• Delivers and receives specimens to internal laboratory and/or ship specimens to a referral laboratory as specified by the protocol.
• Works with the statistician to clean and prepare data sets for analyses.
• Collects, sorts, files, and maintains all paper and electronic documents related to the protocol. Evaluates proposed amendments of the study to identify any changes in laboratory testing requirements as approved by the IRB, Institutional IACUC.
• Maintains complete and accurate drug and equipment accountability at all times for the study.
• Identifies delays and other shortcomings in meeting objective and develops a contingency plan as required.
• Communicates and provides information during any sponsored Contracting Officer Representative (COR) site visit related to the study.
• Assists the PIs to write the final report and submit it to the IRB, IACUC, and study sponsor. Manages all aspects of laboratory experiments while in constant communication with the PIs and CRD leadership.
• Actively seeks to learn new laboratory techniques to support new protocol requirements. Manages all laboratory testing requirements to support translational and clinical research projects in concert with the PI.
• Arranges learning schedules for Graduate Medical Education (GME) personnel working in the clinical and translational research programs.

Minimum Qualification and Experience: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.)

• Master’s Degree in Molecular Biology or science-related degree with 2+ years’ experience or minimum of Bachelor’s Degree in Molecular Biology with 5 years of recent experience in a molecular biology laboratory.
• Shall have at least 5 years of experience in advanced Molecular Laboratory procedures and experience research laboratory procedures including but not limited to research specimens from various species, experience using basic and advance laboratory instrumentation, using various testing techniques to determine biological activity, metabolic changes, or biology products, experience in the collection and processing of various biological samples for frozen long term storage and the procedures to recover samples from long term storage for analysis.
• Experience or knowledge in performing translational biomedical research, and working in a laboratory performing various techniques to include but not limited to: flow Cytometry, research involving the use of specimens, PCR/rtPCR testing, expertise in the use and enzyme immunoassay testing assays, use of laboratory equipment including imaging systems, chemistry equipment (i.e., HPLC, GS-MS, etc.), hematology and clinical chemistry analyzers, coagulation testing, experience in cell culture techniques, and extensive experience in collecting processing and archiving specimens for use in translational biomedical research.

Must have and maintain a current Basic Life Support (BLS) certification.

Benefits:

Emerge Solutions Group, LLC is committed to hiring and retaining a highly qualified, merit-based workforce. We offer participation in company-sponsored benefits plans – subject to meeting hours and waiting period requirements – to include employer-contributed Health Insurance, Dental, Short-Term & Long-Term Disability, Life Insurance, and employer-matched 401(K) Retirement Plan.