Clinical Research Assistant

at  Chenega Corporation

Overview:
Come join a company that strives for Extraordinary People and Exceptional Performance! Chenega Enterprise Systems and Solutions, LLC, a Chenega Professional Services’ company, is looking for a Clinical Research Assistant who will conduct basic, translational, and clinical studies (i.e., bench to bedside) focused on the development and evaluation of next generation technologies and approaches for the treatment of traumatic extremity injuries. performs a broad range of administrative and technical duties in support of the research activities.
We are looking for creative, collaborative, experienced, and driven individuals to join our team!
Our company offers employees the opportunity to join a team where there is a robust employee benefits program, management engagement, quality leadership, an atmosphere of teamwork, recognition for performance, and promotion opportunities. We actively strive to channel our highly engaged employee’s knowledge, critical thinking, and determination to innovate scalable solutions for our clients.

Responsibilities:

• Shall monitor pre-clinical and/or clinical studies to assure compliance with applicable DoD, national, and international laws and regulations, and to ensure that the safety and privacy of participants are protected
• Shall ensure compliance with protocol
• Shall acquire, analyze and evaluate pre-clinical and/or clinical data gathered during clinical research and assure accurate and complete documentation, and protocol execution
• Shall assist laboratory investigatory projects including collection and organization of data. Maintains compliance with established laboratory safety and other procedures. Oversees and ensures the proper disposal of infectious and hazardous materials
• Shall provide quality control, trouble shooting, and the maintenance of specialized reagents and equipment
• Shall provide organizational support by ensuring the successful coordination (e.g., preparation, submission, and tracking of all required documentation) of all personnel training requirements, laboratory space utilization, conference and travel approvals, new equipment requests, and tracking of maintenance/service of existing equipment
• Shall facilitate the development and execution of new data collection and management processes and procedures. shall participate in data collection of approved research studies; participates in the development of data collection and data entry processes and the analysis to include the preparation of research/progress reports, and preparation of the EACE Biannual Update to the EACE Director; reviews data collection processes with staff and subjects and oversees obtaining informed consent process. Prepares technical reports, summaries, and protocols
• Shall maintain clear and accurate laboratory records, inventories, and logbooks. Performs data entry for clinical research projects and will maintain data and databases
• Shall participate/present findings at lectures, seminars, and annual conferences
• Shall manage scientific references and perform literature searches and retrospective data reviews to remain current in the applicable fields. Requests, compiles, and analyzes data to develop reports for EACE sponsors, and various medical, legal, and regulatory bodies, as appropriate; facilitates preparation of historical reports and other progress reports, as requested; tracks and documents all information products emanating from EACE research protocols; evaluates presentations, abstracts, articles, and books related to activities for internal consistency and compliance with applicable regulation. Facilitates Public Affairs Office (PAO) approval of manuscripts and abstract submissions as well as presentations
• Provides broad administrative support to the EACE Facility Research Director or Senior Scientist. Shall assist in arranging meetings, conferences, and visit requests; maintains office calendars and appointment/meeting schedules as appropriate; prepares meeting agendas and documents summary of minutes from meetings and conferences; and drafts correspondence for the EACE Facility Research Director’s or Senior Scientist’s signature.
• Serves as reviewer and prepares authorizations for Defense Travel System (DTS) and primary liaison between EACE, resource management, and human resources agencies. Processes and independently resolves situations regarding DTS voucher payments for travel claims and takes correction action on any deficiencies. Analyzes all information concerning pay, time and attendance, and other personnel related actions. Researches appropriate personnel actions required to accomplish management’s objectives. Presents applicable options and regulatory requirements. Executes management’s decisions regarding personnel management matters using appropriate information systems and liaison to civilian personnel office and EACE Headquarters
• Shall provide administrative support for budget operations, to include updating, revising, sorting, calculating, manipulating, and converting spreadsheet data into various formats, programs, and reports using advanced office automation skills. Converts spreadsheet data into charts, graphs, and report formats and from one software program to another; monitors the use and expenditure rate of budgeted funds through analysis of financial reports, historical data, and continuous dialogue with collaborators to include the EACE Headquarters Resource Manager
• Shall prepare presentations for publication to include figures, tables, images, and methodological text
• Other duties as assigned

Qualifications:

• 3 years’ experience working as a Research Assistant
• Bachelor’s Degree in a healthcare field
• Must be able to obtain a Secret Clearance or favorable T1 investigation (as applicable to location)
• practical understanding of the administrative procedures and requirements pertaining to clinical investigation protocols.
• practical knowledge of research methods and medical terminology.
• Practical knowledge of pre-clinical and/or clinical investigation/research and associated regulatory requirements ensuring compliance with applicable laws, regulations, guidelines, and policies.
• Ability to ensure proper research protocols are followed and documentation is properly completed, filed, and tracked in accordance with appropriate regulatory and review committee policies.
• An understanding of HIPAA and securing PHI/PII.
• Experience in the development and standardization of audit tools and report formats.
• Experience in the development and maintenance of a quality assurance program.
• Experience in performing various administrative duties utilizing Microsoft Office software (e.g. Outlook, Word, PowerPoint, and Excel).
• Experience in data generation, analysis, and report creation

Teleworking Permitted?: false Teleworking Details: situational only Candidate must be in Fort Bragg North Carolina Estimated Salary/Wage: USD $46,126.62/Yr. Up to USD $70,000.00/Yr

• Shall monitor pre-clinical and/or clinical studies to assure compliance with applicable DoD, national, and international laws and regulations, and to ensure that the safety and privacy of participants are protected
• Shall ensure compliance with protocol
• Shall acquire, analyze and evaluate pre-clinical and/or clinical data gathered during clinical research and assure accurate and complete documentation, and protocol execution
• Shall assist laboratory investigatory projects including collection and organization of data. Maintains compliance with established laboratory safety and other procedures. Oversees and ensures the proper disposal of infectious and hazardous materials
• Shall provide quality control, trouble shooting, and the maintenance of specialized reagents and equipment
• Shall provide organizational support by ensuring the successful coordination (e.g., preparation, submission, and tracking of all required documentation) of all personnel training requirements, laboratory space utilization, conference and travel approvals, new equipment requests, and tracking of maintenance/service of existing equipment
• Shall facilitate the development and execution of new data collection and management processes and procedures. shall participate in data collection of approved research studies; participates in the development of data collection and data entry processes and the analysis to include the preparation of research/progress reports, and preparation of the EACE Biannual Update to the EACE Director; reviews data collection processes with staff and subjects and oversees obtaining informed consent process. Prepares technical reports, summaries, and protocols
• Shall maintain clear and accurate laboratory records, inventories, and logbooks. Performs data entry for clinical research projects and will maintain data and databases
• Shall participate/present findings at lectures, seminars, and annual conferences
• Shall manage scientific references and perform literature searches and retrospective data reviews to remain current in the applicable fields. Requests, compiles, and analyzes data to develop reports for EACE sponsors, and various medical, legal, and regulatory bodies, as appropriate; facilitates preparation of historical reports and other progress reports, as requested; tracks and documents all information products emanating from EACE research protocols; evaluates presentations, abstracts, articles, and books related to activities for internal consistency and compliance with applicable regulation. Facilitates Public Affairs Office (PAO) approval of manuscripts and abstract submissions as well as presentations
• Provides broad administrative support to the EACE Facility Research Director or Senior Scientist. Shall assist in arranging meetings, conferences, and visit requests; maintains office calendars and appointment/meeting schedules as appropriate; prepares meeting agendas and documents summary of minutes from meetings and conferences; and drafts correspondence for the EACE Facility Research Director’s or Senior Scientist’s signature.
• Serves as reviewer and prepares authorizations for Defense Travel System (DTS) and primary liaison between EACE, resource management, and human resources agencies. Processes and independently resolves situations regarding DTS voucher payments for travel claims and takes correction action on any deficiencies. Analyzes all information concerning pay, time and attendance, and other personnel related actions. Researches appropriate personnel actions required to accomplish management’s objectives. Presents applicable options and regulatory requirements. Executes management’s decisions regarding personnel management matters using appropriate information systems and liaison to civilian personnel office and EACE Headquarters
• Shall provide administrative support for budget operations, to include updating, revising, sorting, calculating, manipulating, and converting spreadsheet data into various formats, programs, and reports using advanced office automation skills. Converts spreadsheet data into charts, graphs, and report formats and from one software program to another; monitors the use and expenditure rate of budgeted funds through analysis of financial reports, historical data, and continuous dialogue with collaborators to include the EACE Headquarters Resource Manager
• Shall prepare presentations for publication to include figures, tables, images, and methodological text
• Other duties as assigne