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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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Health Division Checkmark Icon Health Division

Medical Writer Associate

Full Time - Health Division

Job Description: This position involves coordinating, attending, and, at times, leading conference calls/meetings related to clinical trials; preparing meeting minutes/action items and distributing these to meeting participants; preparing, or assisting in the preparation of, medical/scientific/regulatory documents, SOPs, and miscellaneous documents; maintaining databases and data entry and mining.

Requirements: Requirements include a BS (with 2+ year’s work experience) or MS in a health/science field.; excellent oral and written communications skills, attention to detail, and organization skills; and a strong command of MS Word and Excel. Experience with MS SharePoint is also desired.

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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 or equivalent related experience, 2-5 years regulatory or relevant work experience, Excellent oral, written, interpersonal and organizational skills, Solid computer skills; experience using Microsoft Office; Medical background preferred. Exposure to GCPs and clinical trials is a must.

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Manager, Quality Assurance

Full Time - Health Division

Job Description: This leader will plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks; assess GCP compliance risk areas and develop and implement risk mitigation measures; ensure compliance with company’s procedures and regulatory requirements; conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports); review and provide input in to non-clinical documentation (e.g. protocols, study reports); facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies; participate in the evaluation and selection of “CROs and other clinical and nonclinical service providers; provide guidance, interpretation and information on GCP regulations, standards and quality systems; develop and implement standards, policies and procedures for GCP regulatory compliance; and develop and measure quality metrics to drive consistent quality standards relating to GCP activities.

Requirements: Master’s Degree preferred with minimal 10 years’ experience in Biotech or Pharma and 5+ years’ experience in Quality Systems related to GCP ; strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement; extensive experience auditing clinical CRO’s, clinical sites and investigator sites; an understanding of domestic and international regulatory requirements; outstanding communication skills (interpersonal, verbal and written); a proven track record of industry success; and strong leadership and management skills.

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Safety and Pharmacovigilence Specialist

Full Time - Health Division

Job Description: Performs various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation, preparation of IND safety reports for submission to the FDA, safety document or data analysis, and clinical trial site support.

Requirements: M.D. or D.O. from an accredited institution or RN, PhD, PharmD, or MPH with direct Drug Safety experience, Infectious disease and/or oncology subspecialty highly preferred; knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential; knowledge of CTC and/or MedDRA coding preferred; experience leading clinical and cross functional teams is a plus; must have excellent oral, written, presentation and computer skills; 2+ years of pharmaceutical or biotech industry or academic experience.

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Regulatory Associate

Full Time - Health Division

Job Description: Reproduces simple and complex documents for submission to regulatory agencies and distribution to stakeholders; utilizes and maintains hard copy and electronic filing systems for auditable regulatory documents; maintains effective high-profile communications and interactions with colleagues, collaborators, and clients as appropriate; drafts, edits, and distributes various documents as needed based on templates and work instructions; develops and maintains work process tools to promote efficiency and productivity, which may include templates, SOPs, work instructions, checklists, etc.; tracks regulatory activity in a Clinical Trial Management System and ensures that records are complete and current; provides other administrative regulatory support as needed.

Requirements: Bachelor’s Degree in the Life Sciences or a related field with 0-2 years of work experience preferred; must have excellent verbal and written communication skills; superior organizational skills and customer service abilities are required; 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; exposure to clinical trials, research, or a medical background is a plus.

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Quality Assurance Specialist III

Full Time - Health Division

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; available and able to travel up to 30%.

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Medical 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: Requirements include an 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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Clinical Research Associate II

Full Time - Health Division

Job Description: Provides site monitoring and site management services for sponsored clinical trials; conducts on-site pre-study/qualification, initiation, routine, and close-out monitoring visits, following corporate and/or sponsor Standard Operating Procedures (SOPs) and other requirements; performs on-site and remote source document verification, data review, study product reconciliation, and regulatory binder review; prepares visit reports and provides assistance to site staff in resolving deficiencies; develops and demonstrates understanding of assigned therapeutic areas and applies knowledge to study and project-related issues; educates and trains site and study staff in study conduct, including compliance with FDA and ICH/GCP guidelines; collects and reviews regulatory documents in compliance with guidelines and standards; assists in Protocol, Informed Consent, and CRF design and review; appropriately resolves issues related to site monitoring and management with guidance from the Project Manager; makes decisions independently and with some supervision from Line or Project Manager; Develops and applies efficient computer tools to carry out job functions.

Requirements: Working knowledge of SOPs along with Food and Drug Administration and ICH/GCP guidelines; good communication, organizational, and writing skills; Develops and applies efficient computer tools to carry out job functions; attention to detail; ability to work in a team environment; dependable; assumes responsibility and accepts, supports, and positively facilitates change; ability and availability to communicate with sites in different US time zones; ability to travel (up to 25% of the time), including international travel; BS/MS/RN or equivalent in scientific or healthcare field; three years of pharmaceutical, clinical, or biological research experience with 1–3 years of CRA/CRC experience.

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Project Assistant

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 Specialist

Full Time - Health Division

Job Description: This position will require preparing scientific and regulatory documents (e.g. clinical protocols, investigator’s brochures, informed consent forms, annual reports, investigational new drug applications, new drug applications, regulatory correspondence, and clinical summary reports). Must have the ability to prepare investigator/pharmaceutical company meeting minutes, analyze preclinical and clinical data, prepare reports, perform literature searches and extract information to support regulatory documents.

Requirements: Requirements include a M.S. degree or equivalent with 5 or more years of relevant work experience or a Ph.D. with 1 or more years of relevant work experience in pharmacology, toxicology, biochemistry, molecular biology, immunology, or a related field; knowledge of US and non-US regulatory requirements; excellent oral, written, and interpersonal skills; high attention to detail; ability to analyze medical research data and review experimental protocols; and working knowledge of word processing, Adobe Acrobat, spreadsheet, and database management programs.

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Safety and Pharmacovigilance Associate I

Full Time - Health Division

Job Description: This position will manage and process SAEs; assist in the preparation of reports; generate specified data reports from the database; process and review investigator safety reports and notifications for non-IND adverse event reports; process and review safety narratives for IND and non-IND Adverse Event cases as required; maintain electronic files for the department; and query SAE databases.

Requirements: Requirements include a B.A./B.S. degree in a relevant field, MS degree in related field a plus, 0-5 years of pharmaceutical, biologics, and/or diagnostic experience, as well as excellent oral, written, and computer skills including database experience. Experience with medical terminology is preferred.

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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

Manager, Software Development

Full Time - Information Technology

Job Description: Leads team of six developers in SharePoint 2010 and ASP.NET 4.0 solutions development; develops and enforces development standards and procedures to ensure quality and adherence to project schedules and constraints; evaluates and improves IT services and capabilities in system architecture and infrastructure domains; develops, codes, installs, tests, debugs, and documents Web applications using current .NET and SharePoint 2010 development strategies; customizes new and existing SharePoint 2007 and 2010 solutions through Visual Studio 2010 and SharePoint Designer, to include creation of custom web parts, reports, workflows, pages, and InfoPath forms; provides mentoring and in-house training to development staff on best practices and tools; diagnoses and troubleshoots problems with existing Web applications and sites; conducts research into current and emerging Web technologies and issues in support of Web development efforts; ensures security of all Web sites and related applications; performs periodic Web site audits; interact with users, production support and other project team members to understand the business and technical requirements.

Requirements: Bachelor’s degree in Computer Science, Management Information Systems or related discipline; Master’s degree preferred; current certifications (e.g. MCSD, MCP, etc) strongly preferred; practical experience with CMMI, ITIL and ISO 20000 strongly preferred; 10 years’ experience and strong understanding of Internet applications development using.NET and SharePoint*; 5 years’ experience managing software development using SCRUM and/or other Agile methodology; experience with RUP and other methodologies strongly preferred; experience with SOA and ASP.NET web service implementations required; experience working with K2 BlackPearl or K2 BlackPoint strongly preferred; prefer knowledge of database development, including Oracle 10 and SQL Server 2008. *NOTE: this is not SharePoint Administration using browser administration console, but actual programming. SharePoint 2010 experience required.

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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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Administration Division Checkmark Icon Administration Division

Financial Analyst

Full Time - Administration Division

Job Description: A financial analyst develops and manages project budgets, expenditures, and projections with the responsibility to advise, analyze, and establish budget objectives. Interacts with Project Managers/Task Order Managers, Contracts, and other support organizations. Implements financial policies and procedures. Establishes and maintains cost/schedule baselines, develops Work Breakdown Structures (WBS) and schedules. Understands schedules, critical path, and performs related analyses. May assist in new business proposals providing input and cost volumes to management. Provides data and reporting formats for all types and levels of project reviews. Performs cost-benefit analyses and recommends process improvement.

Requirements: Requirements include a bachelor’s degree in accounting or related financial field, 5+ years of U.S. Federal and commercial accounting/financial experience. Certified Public Accountant (CPA) is an advantage. Project cost management experience (5+ years), polished verbal, written and presentation skills, as well as the ability to manage multiple pursuits simultaneously. The ideal candidate must be a self-starter and detail-oriented professional who can work independently and within a team environment.

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Manager, Business Development

Full Time - Administration Division

Job Description: This position will lead efforts in identifying, qualifying, pursuing and capturing new business opportunities within the public and private health sector. The ideal candidate will bring a proven track record of success in generating new leads and procuring new clients in the Federal sector. They will also have experience in: receiving and writing to request for proposals (RFPs) and in verbal and written proposal defense.

Requirements: Requirements include a bachelor’s degree in biomedical or related field, 5+ years of U.S. Federal and commercial client development and proposal writing experience. Experience working on clinical research projects, or the National Institutes of Health, United States Army Medical Research Institute, Centers for Disease Control, a plus. Project management experience (5+ years), polished verbal, written and presentation skills, as well as the ability to manage multiple pursuits simultaneously required. The ideal candidate must be a self-starter and detail-oriented professional who can work independently and within a team environment. Must have outstanding organizational, verbal and written skills.

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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 and 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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