The TRI Way
Careers at TRI

Communications Division Lightbulb Icon Communications Division

Task Manager/ Instructional Designer

Full Time - Communications Division

Job Description: Task manager responsibilities include preparing, executing, and monitoring project timelines. Allocating and monitoring resources. Creating, maintaining, and updating project reports (daily, weekly, monthly, quarterly) for both internal and external stakeholders. Additional Instructional Designer (ID) 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. 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.

Requirements: Bachelor's degree in Instructional Design, Education, or related field required. 5+ years of experience in field of expertise, health-related industry is an advantage; 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 (Project 2016 skills a big plus) and SharePoint. Proficiency with eLearning authoring tools (e.g., Captivate and/or Storyline) a plus.

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Health Division Checkmark Icon Health Division

Project Manager, Clinical Operations

Full Time - Health Division

Job Description: As a key member of the clinical operations team, the successful candidate will be responsible for planning, day-to-day operations and vendor management of one or more clinical programs, and providing operational expertise to cross-functional project teams. Core responsibilities include interfacing with the client and project staff, including task managers who oversee the day-to-day operation for multiple functions with constantly shifting priorities and strict project timelines, tracking study progress and managing critical clinical study timelines, while ensuring project quality and compliance with FDA Regulations and with client policies.

Requirements: Requirements include B.S. degree (Masters a plus) with 10-12 years of clinical research experience and a minimum of 5 years of proven project and line management experience in the pharmaceutical/ biotechnology industry or with a CRO, working knowledge of FDA/EMA and other regulatory requirements, GCPs/ICH guidelines; and hands on regulatory, clinical operations, or clinical trial monitoring experience. Demonstrated ability to take a leadership role and drive quality progress. A background in Infectious Disease/HIV clinical trials and/or Oncology is preferred. Experience in the conduct of Phase 1 protocols or prior work on a government contract, e.g., NIH, CDC, DoD, is a plus. Other requirements include strong facilitation, presentation, problem-solving and conflict resolution skills -- including the ability to keep up with rapid changes of priorities, seasoned oral and written communications skills, and strong attention to detail. Experience interacting with IT, the use and development of clinical research databases, such as EDC or CTM systems, and the introduction of system enhancements to support process/data quality improvement are critical to ensure success in this position.

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Director, Data Management

Full Time - Health Division

Job Description: This position entails: overseeing data collection for Phase I-IV clinical studies; supervising Database Programming, and Data Management staff, with all incumbent supervisory responsibilities; establishing staff competency requirements and training programs; mentoring staff and aiding in their development and achievement of competency standards; standardizing, improving, and developing SOPs for database development and data management; approving case report form design, data management plans, and edit specifications; supporting project teams on achieving client satisfaction through delivery of quality data, on-time and on-budget; ensuring revenue and operating margin performance of the data management group to agreed targets; reviewing literature and researching technologies/procedures for improving data management practices; supporting business development and marketing activities at client presentations and professional seminars; participating in proposal development and defense processes; and establishing and maintaining strategic client relationships.

Requirements: MS in a related discipline with 15+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management, and expertise in one or more therapeutic areas; 10 years’ experience as a project manager; understanding of statistical concepts and techniques; SAS programming knowledge; expertise in EDC systems; expert knowledge of clinical data standards and data flows as well as industry standards for submission of data; client management experience; excellent oral and written English and good presentation skills; knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device businesses; and the proven ability to plan and manage capital and operating budgets, as well as planning and advocating for staffing resources.

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Director, Biostatistics

Full Time - Health Division

Job Description: Performs various tasks in support of clinical research, namely: overseeing statistical programming, analysis, and reporting activities for Phase I-IV clinical studies, integrated databases and analyses, safety reviews and ad-hoc analyses; supervising Statistical and Data Programming staff, with all incumbent supervisory responsibilities; establishing staff competency requirements and training programs; mentoring staff and aid in their development and achievement of competency standards; standardizing, improving, and developing SOPs for data analysis and reporting processes; preparing statistical analysis plans for single projects, integrated summaries of safety, and integrated summaries of efficacy; approving case report form design, data management plans, and edit specifications; preparing statistical sections of protocols, including sample size calculations; developing randomization specifications and verifying randomization codes for basic and complex clinical trials; preparing and annotating shell data displays, performing validation and quality control of complex data displays, writing statistical reports and statistical sections of clinical study reports; supporting project teams on achieving client satisfaction through delivery of quality data, on time and on budget; ensuring revenue and operating margin performance of the data management group to agreed-upon targets; reviewing literature and research technologies/procedures for improving statistics and programming practices; supporting business development and marketing activities at client presentations and professional seminars; participating in proposal development and defense processes; and establishing and maintaining strategic client relationships.

Requirements: Ph.D. in statistics or related discipline with 15+ years of experience in the biotechnology, pharmaceutical or health related industry, including significant interactions with regulatory bodies, history of successful management (5+ years), and expertise in one or more therapeutic areas; broad knowledge and superior understanding of advanced statistical concepts and techniques; advanced SAS programming knowledge and proficiency with other statistical packages and sample size calculation software; familiarity with EDC systems; expert knowledge of clinical data standards and data flows as well as industry standards for submission of data; experience overseeing projects that include safety, regulatory, and site operation components, in addition to data management and biostatistics; client management experience; excellent oral and written English and good presentation skills; knowledge of the drug development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical and medical device businesses; and proven ability to plan and manage capital and operating budgets, as well as plan and advocate staffing resources.

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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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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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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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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

Software Tester

Full Time - Information Technology

Job Description: The 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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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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Administration Division Checkmark Icon Administration Division

 

 

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