The TRI Way
Careers at TRI

Communications Division Lightbulb Icon Communications Division

Scientific and Clinical Communication Specialist

Full Time - Health 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.

Click here to apply for this position.

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.

Click here to apply for this position.

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.

Click here to apply for this position.

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.

Click here to apply for this position.

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.

Click here to apply for this position.

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.

Click here to apply for this position.

Medical Writer Associate

Full Time - Health Division

Job Description:

  • 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:

  • BS (with 2+ years work experience) or MS in a health/science field.
  • Excellent oral and written communications skills, attention to detail, and organization skills.
  • Strong command of MS Word and Excel. Experience with MS SharePoint is also desired.

Click here to apply for this position.

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.

Click here to apply for this position.

In-House Clinical Research Associate

Full Time - Health Division

Job Description: This position will review and process essential regulatory documents received from clinical trial sites; request additional information when necessary; respond to protocol and process-related queries; maintain trial master files, and track the process in a centralized Web-based system and/or other databases. Requirements include Bachelor’s degree in life sciences or other health-related field; 2 years of experience in the clinical research arena; and proficiency with Microsoft Office.

Essential Duties and Responsibilities:

  • Review essential regulatory documents (ERD) for accuracy and completeness as required by FDA Regulations, ICHGCP, Sponsor's Requirements and SOPs.
  • Essential regulatory document collection, tracking, and transmittal using electronic systems, interfaces, and databases.
  • Adherence to strict project timelines and expectations.
  • Troubleshoot ERD issues by applying existing knowledge to solve new problems.

Education/Experience Requirement:

  • Experience with essential regulatory document review/collection and knowledge of applicable FDA ICH/GCP guidelines/regulations in a pharmaceutical, clinical research, or clinical site, sponsor, or CRO setting (i.e., In-House CRA, Study Coordinator, IRB Coordinator, and Regulatory Coordinator/Associate/Specialist).
  • BS degree in health-related field or Licensed Practical Nurse.
  • Experience with IRB submissions (OHRP regulations) is a plus.

Knowledge, Skills, and Abilities:

  • Must have excellent time management skills.
  • Able to identify activities along critical path toward individual site activation.
  • Able to multi-task during the review/processing and preparation of essential regulatory documentation.
  • Able to negotiate with investigators, research nurses, and site staff to reach desired resolution.
  • Demonstrated understanding of medical and clinical trials terminology.
  • Knowledge of SAS programming and use a plus.
  • Excellent professional writing and verbal communication skills.
  • Must be self-motivated and have a positive attitude.
  • Excellent organizational and coordination skills with strong attention to detail.

Click here to apply for this position.

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.

Click here to apply for this position.

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

Click here to apply for this position.

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.

Click here to apply for this position.

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..

Click here to apply for this position.

Information Technology Division Gears Icon Information Technology Division

IT Business Analyst

Full Time - Information Technology

Job Description: Develops business process analysis, user/systems requirement analysis and specifications; Gathers both technical and non-technical requirements and creates specification, design and other system development life-cycle documentation; Interacts with internal team members to assure that the system specifications are clearly communicated and documented; Participates 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; Drafts client communications, helps in managing client expectations, and aids in process compliance; Advises on best practices and ways to streamline business processes; May lead to directing the work of others.

Click here to apply for this position.

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

Click here to apply for this position.

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.

Click here to apply for this position.

 

 

© Technical Resources International, Inc.  •  
info@tech-res.com  •  Phone: 301-564-6400