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Careers at TRI

Communications Division Lightbulb Icon Communications Division

Multimedia Designer

Full Time - Communications Division

Job Description: As part of a team, the designer works with the project manager, art director, and key stakeholders to produce accurate and high-quality media solutions for clients in both the public and private sector. Projects require a mix of creative and technical skills in print and digital media to deliver solutions that meet constraints of cost, time, and the client. In addition to being skilled in many types of visual communications design and development (graphic, illustration, photography, elearning, motion graphics, video, etc.), a successful candidate will be proactive, communicate effectively, show attention to detail and be able to work on multiple projects under tight deadlines. A successful candidate must also be able to manage collaboration with multiple stakeholders on a single project, and will be required to receive, organize, and translate feedback into a reasonable and cohesive approach, with guidance from Graphics team supervisors. Print design projects include corporate identity materials, brochures, booklets, newsletters, direct mail, small- and large-format advertisements, and event materials. Digital design projects include Web sites, PowerPoint presentations, e-learning courses, and video graphics.

Requirements: Minimum 4-year degree in an applicable creative arts, media, or design program; 4 years of experience in graphic or multimedia design; strong proficiency with page layout, graphic manipulation, and typography; strong proficiency with design software, including the Adobe Create Suite (InDesign, Photoshop, Illustrator) and Microsoft Office (Word, PowerPoint); comfortable using print and digital media; working knowledge of Web Design, HTML, HTML Animation, CSS, and JavaScript; familiarity with the entire design process from conception to production; proficiency and experience with e-learning development using Adobe Captivate, Articulate, or other elearning software; understand production costs, time management, and organization of project assets; attention to detail; knowledge of current trends in the visual arts. Preferred qualifications: proficiency and experience with e-learning development using Adobe Captivate and Articulate; proficiency and experience with JavaScript; knowledge of video and audio production and editing.

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Scientific and Clinical Communication Specialist

Full Time - Communications Division

Job Description: The ideal candidate must be a self-starter and detail-oriented professional who can work independently and collaboratively within a team environment. Must have outstanding organizational verbal and written skills, experience in tracking, and reviewing scientific and clinical information. Proficiency in the Microsoft Office suite required. Must have the ability to work in a fast-paced environment and achieve high quality results.

Requirements: BS degree; life-science degree would be an advantage. Primary responsibilities include scientific and clinical data collection and analysis; report writing; planning and support of scientific meetings/teleconferences; stakeholder/client communication management and action item tracking with various collaborative groups.

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Trainer/Instructional Designer

Full Time - Communications Division

Job Description: Primary responsibilities include applying the ADDIE model to design and develop effective training programs. Conducts needs assessments. Develops training plans to include learning objectives, target audience, course outlines, case studies, measurement tools, dependencies and sample training materials. Develops a variety of learning resources and materials such as quick start guides, reference guides, instructor guides, participant guides, eLearning storyboards, eLearning courses, and webinar PowerPoint presentations. Researches subject matter and collaborates with subject matter experts to support identified business objectives. Delivers training through one of the following methods: face-to-face, web-conferencing or e-learning. Reports the measured impact of a training solution to the various stakeholders.

Requirements: Bachelor's degree in Instructional Design, Education, or related field required. 5+ years of experience in field of expertise, health-related industry preferable; advanced writing, editing, oral and interpersonal skills; skills in planning, organizing and self-management. Adept at analyzing problems, identifying feasible solutions, and presenting recommendations in a concise, logical and systematic manner. Ability to manage multiple projects at different stages while meeting deadlines and established standards. Proficiency in Microsoft Office. Proficiency with eLearning authoring tools (e.g., Captivate or Storyline) a plus.

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Health Division Checkmark Icon Health Division

Clinical Data Scientist

Full Time - Health Division

Job Description: Managing and sifting through health care and life sciences data sets to extract trends and find patterns; Leveraging existing publicly available databases to supplement the information above; Discovering and exploring data that could lead to new products; Producing reports based on data extracted; Automating report generation by using SAS, SQL, or scripting languages; Validating the methods used in data extraction and data transformation; Researching state-of-the-art techniques for data modeling, analytics, and visualization; Creating intuitive and user-friendly visualizations in Spotfire or other data visualization tools; Working in a team mentoring others and collaborating as a group, in a fast-paced environment; Working with in-house developers for building software tools.

Requirements: Degree in a technical or scientific field or equivalent experience (MS or PhD preferred); Experience with business intelligence; Proficiency with BI tools (e.g., SAS, Tableau, Spotfire, or JMP); Background or experience in health care or life sciences; Excellent oral and written skills; Abstract and critical thinking to work with open-ended or undefined issues; Strategic and cost-effective mindset, self-starter with proactive attitude.

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Clinical Information Specialist

Full Time - Health Division

Job Description: Primary responsibilities include the receipt and abstraction of protocol and/or contact information into the appropriate databases for use by the client and their collaborators in support of clinical trials. Respond to phone or email queries regarding standard processes associated with the abstractions; assist in the preparation of contract required reports; participate in the revision of SOPs and work instructions as necessary and appropriate; handle special client requests as assigned. Other duties as assigned.

Requirements:B.S. or B.A. degree (with 3+ years’ work experience) or MS in health/science field. Relevant work experience such as regulatory affairs or clinical trials experience a plus. Excellent oral, written, interpersonal and organizational skills. Solid computer skills including database experience. Experience using Microsoft Office. Scientific or medical background preferred. Exposure to GCPs and clinical trials a plus.

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Regulatory Associate

Full Time - Health Division

Job Description: Prepare standard documentation supporting regulatory filings. Maintain files for regulatory documents. Maintain and update database. Write and maintain Standard Operating Procedures and Work Instructions. Provide administrative support and other duties as assigned.

Requirements:B.A./B.S. degree. Proficiency in MS Word and MS Excel. Well-organized self-starter with excellent written and verbal communication skills. Experience using electronic submission software and proficiency in preparing documents that are compliant with electronic submission standards is preferred. Attention to detail is essential; familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable. General knowledge of the drug development process or clinical trials is a plus.

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Medical/Science Writer

Full Time - Health Division

Job Description: This position involves preparing scientific and regulatory documents on behalf of government and private sector clients for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator’s Brochures); performing literature searches; preparing and editing manuscripts, meeting reports and proceedings, and safety documents; and data analysis.

Requirements: M.S. degree or equivalent with 3 or more years of relevant work experience or a Ph.D. in pharmacology, biochemistry, molecular biology, immunology, or a related field; oncology and/or immunology background highly desirable. Requires excellent oral, written, data interpretation, and computer skills (experience with PC-based systems and MS Office required) and high attention to detail. Familiarity with database design, FDA regulations, and/or clinical research highly desirable.

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Regulatory Operations Associate

Full Time - Health Division

Responsibilities:

  • Prepare standard documentation supporting regulatory filings and distribution to stakeholders.
  • Utilize and maintain hard copy and electronic filing systems for auditable regulatory documents.
  • Maintain effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate.
  • Draft, edit, and distribute various documents as needed based on templates and work instructions.
  • Develop and maintain work process tools to promote efficiency and productivity. These may include templates, SOPs, work instructions, checklists, etc.
  • Track regulatory activity, maintain and update databases, and ensure that records are complete and current.
  • Provide other administrative regulatory support as needed.

Requirements:

  • B.A./B.S. Degree with 0-2 year’s work experience preferred.
  • Must have excellent attention to detail; verbal and written communication skills.
  • Superior organizational skills and customer service abilities are required.
  • Experience publishing regulatory submissions using electronic submission software (such as Extedo) and proficiency in preparing documents that are compliant with electronic submission standards is preferred.
  • Proficiency in MS Office (Word, Excel, and Outlook); experience with SharePoint is a plus.
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
  • Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable.
  • General knowledge of the drug and vaccine development process or clinical trials is a plus.

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Regulatory Operations Manager

Full Time - Health Division

Job Description:

This position is part of a team supporting government-sponsored clinical trials. The key responsibilities include:

  • Overseeing and managing electronic regulatory submissions in support of active and planned investigational applications (INDs, NDAs, BLAs, IDEs, etc.) corporate-wide
  • Applying knowledge of electronic publishing requirements to ensure compliance with agency submission requirements
  • Remaining current with evolving standards for electronic submissions
  • Training team members on how to prepare and submit electronic document packages (e.g., formatting documents, publishing using electronic submission software, submission through the FDA’s ESG)
  • Keeping abreast of regulatory procedures and changes 
  • Cross-training into other areas of regulatory support is expected.

Requirements:

Requirements include a B.A./B.S. degree in the Life Sciences or a related field, and self-starting ability with excellent written and verbal communication skills. Experience using electronic submission software is essential, as is proficiency in preparing documents that are compliant with electronic submission standards. Proficiency in MS Word, MS Excel, and Adobe Acrobat is also essential. Prior managerial experience is preferred. Familiarity with Good Clinical Practices and/or experience of working in an FDA-regulated environment is desirable. Familiarity with Microsoft Access and SharePoint is a definite plus, as is general knowledge of the drug development process or clinical trials.

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Safety and Pharmacovigilance Associate I

Full Time - Health Division

Job Description:

  • Manage and process all SAEs as per project specific instructions
  • Document Control:  maintain electronic files for department, perform file case searches, maintain file room for the department and use department databases to track, manage and control issued documents; assign various tracking numbers
  • Track and process assigned pharmaceutical and Data Management Center (DMC) queries
  • Assist in the preparation of contract-required reports
  • Generate specified data reports from the safety database as requested
  • Process and edit safety narratives for IND and Non-IND Adverse Event (AE) cases as required
  • Distribute Safety Information according to project specific requirements
  • Assist in processing of MedDRA coding tasks
  • Perform QC on AE submissions

Requirements:

Educational Requirements:

  • Bachelor's degree in relevant field

Required experience:

  • 0-2 years of pharmaceutical, biologics, and/or diagnostic experience
  • Excellent oral, written, and computer skills
  • Ability to analyze medical research data, review experimental protocols, and summarize safety data
  • Medical terminology

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QA Specialist III

Full Time - Information Technology

Job Description: Responsible for verifying compliance to applicable Standard Operating Procedures (SOPs) and regulations by performing internal audits; promotes quality by preparing Project Specific Procedures, providing training to staff and supporting the Quality Management System; responsibilities may also include hosting client audits, conducting external audits at clinical sites and vendor sites, leading process improvement activities and leading CAPA investigations; conducts quality focused trainings via Web-Ex and face-to-face sessions.

Requirements: Minimum a BS/BA; a Master’s Degree desired but not required; 3-5 years of progressive QA experience preferably in a CRO environment; a solid understanding and working knowledge of GCP (minimum 5 years); experience working with Quality Management Systems; training experienced via Web-Ex or face to face; proficiency in MS Office; ability and availability to travel up to 30% of the time.

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Human Subjects Protection Specialist

Full Time - Health Division

Job Description: This position will act as a Clinical Research Ethicist, providing expertise on the implementation of relevant Human Subjects Protection regulations in clinical research. Responsibilities include conducting regulatory and bioethical reviews of clinical trial protocols, including domestic and international sample and site-specific informed consent documents, for compliance with applicable federal regulations and policies; conducting literature reviews of ethical codes, regulations, and guidance documents relevant to human subjects protection in clinical research; training and supervising staff on application of federal regulations; developing, reviewing, and updating informed consent templates, SOPs and internal guidelines to promote high quality work product.

Requirements: Requirements include a relevant Ph.D. or a master’s degree with at least 2 years of experience in bioethics or a clinical research environment, and excellent writing and interpersonal skills. The ideal candidate will have a working knowledge of the Common Rule and other regulations/policies relevant to the protection of human subjects. Experience in medical writing, IRB activities, infectious diseases, working with HIV patients, and/or regulatory affairs is highly desirable.

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Information Technology Division Gears Icon Information Technology Division

Senior SharePoint Developer

Full Time - Information Technology

Job Description: This position will be responsible for: developing, coding, installing, testing, debugging, and documenting Web applications using current .NET and SharePoint 2010/2013 development strategies; customizing new and existing SharePoint 2010 and 2013 custom solutions through Visual Studio 2012 and SharePoint Designer, to include creation of new workflows, standalone Web parts and BDC objects to allow for real-time views into internal or external databases; establishing policies and procedures for publishing Web pages and applications in conjunction with content creators; applying an excellent understanding of the software development process, including design patterns, requirements analysis, testing, and deployment; conducting research into current and emerging Web technologies and issues in support of Web development efforts; developing (coding), implement and maintain tools/applications in order to ensure applications and systems possess exhibit sufficient controls; performing unit testing prior to moving code/configuration to the QA process, evaluating and researching upgrades, patches and new functionality, and researching defects and solving for root cause; assisting in the development and definition of test plans and scripts for performance, regression and user acceptance test plans; supporting QA activities as required; ensuring security of all Web sites and related applications; interacting with users, production support and other project team members to understand the business and technical requirements; participating in setting organizational Web development strategy; and working with the architecture team to implement best practices and design patterns.

Requirements: Minimum of 7+ years of experience in software development (SharePoint and / .Net); a Bachelor's degree in Computer Science, IT, Engineering, or a related field; current certifications (e.g. MCSD, MCP, etc.) preferred; 5+ years hands-on experience with SharePoint Platforms (2010, 2013); minimum of 7+ years of experience with software development in Microsoft .Net framework using C# language with strong emphasis on Object Oriented programming and design patterns experience analyzing applications for compliance with security protocols; experience with web services and SOA architecture; strong knowledge of JavaScript and JavaScript frameworks such as jQuery, Angular.js, Ember, etc.; a strong background in .NET with SharePoint 2013 Object Model experience; experience working with database administrator to design, develop, and update databases as they relate to Web applications; familiarity with CSS3, HTML5, and Frameworks including Bootstrap vs Foundation; deep experience in IT solution delivery and SharePoint Object Model Architecture; senior developer experience in development, facilitation, mentoring and demonstrates the ability to multi-task and use technical & creative problem solving; a successful track record of working cross-functionally with different sets of stakeholders and aligning interests in order to ensure success towards a common goal; experience collaborating with Architecture, Program Management and Infrastructure teams by identifying and providing perspective on key technical issues and liaising with other IT teams to execute complex application performance and security analysis; excellent knowledge of applicable data privacy practices and law; ability to effectively communicate, written and orally, with other team members; self-motivated to conduct research into emerging Internet technologies and programming languages; presenting ideas in business-friendly and user-friendly language; highly self-motivated and directed; keen attention to detail; proven analytical, problem-solving and mentoring abilities; ability to effectively prioritize and execute tasks in a high-pressure environment; very strong customer service / delivery orientation.

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IT Business Analyst

Full Time - Information Technology

Job Description: This position will be responsible for: developing business process analysis, user/systems requirement analysis and specifications; gathering both technical and non-technical requirements and creating specification, design and other system development life-cycle documentation; interacting with internal team members to assure that system specifications are clearly communicated and documented; participating in the development of tests plans and test cases.

Requirements: Bachelor’s degree in Computer Science or related field; 5 years related experience; working knowledge of relational database concepts; knowledge of web architectures and object oriented technologies; excellent interpersonal, verbal and written communication skills with the ability to communicate technical problems to non-technical audiences; experience drafting client communications, helping manage client expectations, and aiding in process compliance; proven ability to advise on best practices and ways to streamline business processes. Previous management experience a plus.

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SAS and R Developer

Full Time - Information Technology

Job Description: TRI is seeking a SAS and R Developer to join its Data Analytics and Bioinformatics Team and participate in building products based on healthcare data. The Developer will prepare, manage and analyze research data sets using standard statistical SAS packages and SAS programming. In addition to SAS, the ideal candidate will also be comfortable working with the R programming language and knowledge of standard R packages.

Job responsibilities include:

  • Developing SAS or R programs that extract data from multiple datasets and perform calculations
  • Managing and sifting through health care data to extract trends and find patterns
  • Creating SAS datasets and producing reports based on data extracted
  • Performing QC of data and validating the codes created
  • Creating documentation for each code release
  • Troubleshooting and solving problems in the SAS or R codes
  • Coordinating with Database Administrators, Business Analysts, and Testers in order to solve issues that may arise
  • Working in a team mentoring others and collaborating as a group, in a fast-paced environment

Requirements:

  • Bachelor’s degree in Computer Science or related field
  • Proficiency in SAS programming
  • Proficiency in R programming
  • 3+ years of experience working in a biology or clinical research setting
  • Experience working with complex data from relational databases
  • Attention to detail
  • Strong communication skills (written and oral)
  • Ability to multitask

Desired skills include:

  • Experience leading development of software products
  • Experience with Agile methodology
  • Experience with data visualization tools such as SAS Analytics or Spotfire

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IT Support Specialist

Full Time - Information Technology

Job Description: This position will be responsible for installation, support and maintenance of corporate workstations, conferencing and supporting infrastructure. This position supports custom applications, hardware and Windows-based operating systems. Knowledge of workstation hardware and network security is essential. This position is also expected to coach and educate non-technical personnel and work with other IT staff in the development of the corporate IT knowledge base.

Requirements: Requirements include an Associate’s degree or Technical School completion, in addition to 1-3 years’ experience in technical support for Intel-based workstations, Microsoft Windows XP and Vista desktop platforms, Microsoft Windows 2003 server platforms, Microsoft Office 2003/2007 productivity applications, experience with adding users and manipulating objects in Active Directory, experience with networking standards and protocols, the ability to support desktop and laptop computers, printers, and peripheral devices, and familiar with cloning technologies. CompTIA A+ or MCP certification is a plus. B.S. in Computer Science preferred.

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Software Tester

Full Time - Information Technology

Job Description: Software Tester’s primary role will be verification and validation activities which includes eEnsure work products meet their specified requirement, review and approve software developer unit cases, draft test plans and test cases for integration testing and other forms of testing including boundary positive/negative, functional, system, stress, load, performance, usability, security, install/uninstall, etc., draft User Acceptance, Operational Qualification, and Performance Qualification Testing scripts and review with end users or other team members, facilitate User Acceptance Testing and other Validation activities with end users. The Tester will work closely with the business analyst and participate in peer reviews to ensure requirements are understood. This individual will also work closely with software developers to ensure communication coordination of releases for testing in the appropriate environment.

Requirements: B.S. degree in Computer Science or similar technical degree, 4-5 years in Software Quality Assurance, and experience in writing test plans and test cases against software requirements specification documents. This candidate will have knowledge of software and system development methodologies, software programming, the ability to program simple to moderate SQL scripts and experience using risk management as an approach for developing test cases and focusing testing efforts.

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Administration Division Checkmark Icon Administration Division

Manager, Contracts

Full Time - Administration Division

Job Description: The qualified individual will be an integral member of the Department, assisting with entire life cycle of contracts activities including but not limited to: reviewing solicitations and preparing business/cost proposals; performing cost/price analysis of subcontractor proposals; negotiating contracts in conjunction with Corporate Counsel; analyzing contract terms and conditions, and administering contracts to ensure compliance (including timely authorizations and modifications); effectively interfacing with client contracts representatives; monitoring contract budgets, expenditures, and projections; providing contractual guidance to project managers and other staff; performing SBA small business reporting and assisting with subcontracting goals; and coordinating close-out activities.

Requirements: Minimum requirements include: a Bachelor’s Degree, preferably (or with significant course coverage) in business, or contracts management; 3-5 years of contracts management experience. A Master’s Degree in business is also highly desirable. Other requirements include: excellent analytical, and oral and written communication skills; attention to detail and follow-up; experience with spreadsheet software (Excel); experience managing full range of contract types and requirements from cradle to grave (especially Government contracts); and knowledge of Federal Acquisition Regulations. Experience with GSA FSS contracts, small business subcontracting/reporting, and Certified Professional Contracts Manager (CPCM) status, preferred.

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