Summary
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 Research Program Coordinator to support clinical investigation studies aimed at improving the function and quality of life for patients with traumatic extremity injuries and performs a broad range of administrative and technical duties in support of EACE clinical research activities the Extremity Trauma and Amputation Center of Excellence (EACE) clinical research activities at Fort Liberty, NC.
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 provide a practical knowledge of research methods along with knowledge of medical terminology. Such knowledge, skill and ability shall be demonstrated in all written and reviewed abstracts, proposals, protocols, presentations and publications delivered
Shall utilize knowledge of and experience with pre-clinical and/or clinical investigations/research and the associated regulatory requirements. shall protect human subjects by advising investigators on complex ethical, legal, and procedural requirements for protocol development. answer inquiries from investigators to assist in meeting all requirements; reviews draft protocols to assure the investigator has complied with federal, Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), the Health Insurance Portability and Accountability Act (HIPAA), and Defense Health Agency regulations pertaining to the administrative conduct of and assures conformance with pertinent applicable local, regional, and national laws, regulations, guidelines, and policies concerning the protection of human and non-human participants
Shall provide support to investigators on generating and/or revising Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) protocols in accordance with requirements imposed by such committees
Shall ensure consent is properly obtained from participants; and, documents are properly completed, filed, and tracked in accordance with appropriate regulatory and review committee policies. shall complete reviews of documentation with sufficient lead-time to maintain continued approval of study
Shall prepare closure documentation and contribute to preparation of final reports to the regulatory committees and/or funding agency or other entities
Shall oversee the development of audit tools and standardized audit report formats; assists with development of laboratory policies to maintain and enhance a robust quality assurance program; reviews the Federal Register and new or revised regulations to include Defense Health Agency (DHA)and site specific requirements, Department of Health and Human Services (HHS), Federal Drug Administration (FDA) and the Human Research Protections Office (HRPO), and other issuances pertinent to the investigative program and regulations/guidelines for investigators, based on directives and policies of higher agencies
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 team members
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 tracking, conference travel approvals, Defense Travel System (DTS) Reviewing Official (RO) requirements for travel, new equipment requests, and tracking of maintenance/service of existing equipment
Shall request, compile, and analyze data to develop reports for EACE leadership, 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 clinical investigation protocols; evaluates presentations, abstracts, articles, and books related to activities for internal consistency and compliance with applicable regulations; and facilitates required approvals of manuscript and abstract submissions as well as presentations
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; ensures all budgetary information remains confidential and is only shared with individuals designated to receive the information
Shall serve as the principle liaison for both patients undergoing clinical evaluations and study subjects within the EACE portfolio. responsible for coordination, identification, and recruitment of potential volunteers for studies in accordance with approved clinical research protocols. coordinates the scheduling of assessment and treatment sessions for patients, to include entry into the necessary calendar systems and verification of eligibility and availability. Additionally, assures volunteers have access to principle investigators for any questions that may arise during the course of the clinical investigation study, and advises both human subjects and investigators on clinical safety as related to clinical studies
Qualifications
Minimum 5 years of experience in research with current experience within the last 3 years.
Must have, or the ability to obtain, a SECRET clearance
A substantial, practical understanding of the administrative procedures and requirements pertaining to clinical investigation protocols.
Experience in studies with a practical knowledge of research methods and medical terminology.
Experience with pre-clinical and/or clinical investigation/research and associated regulatory requirements ensuring compliance with applicable laws, regulations, guidelines, and policies.
Ability to support investigators on generating and revising protocols in accordance with specified requirements
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 Details
situational telework only candidate must be in Fort Liberty, North Carolina.
Estimated Salary/Wage
USD $61,393.53/Yr. Up to USD $73,000.00/Yr.
Chenega Corporation and family of companies is an EOE.
Equal Opportunity Employer/Veterans/Disabled
Native preference under PL 93-638.
We participate in the E-Verify Employment Verification Program
