Join Our Team

Our team brings value to the research industry through experience, expertise, and passion. If you thrive when facing challenges and tight timelines and want to apply your skills in the clinical research field to a rewarding career, join the Trial Runners team.

Programmer Analyst

Biostatistics

Working within the Clinical Operations Department and Programming/Biostats functional unit, the Programmer Analyst is responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans. This position is also responsible a number of other activities related to the creation of statistical outputs for a clinical trial.

RESPONSIBILITIES:

  • Follow departmental SOPs and guidelines
  • Assure Good Clinical Practices, investigator integrity, and compliance with all study procedures.
  • Ensured completeness, accuracy, and consistency of the data so that it meets the standards of quality expected for reporting to regulatory bodies while following Good Clinical Practices (GCP) and FDA’s validation rules for submission datasets and SDTM IG 3.2.
  • Works with data management to identify issues in data quality
  • Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
  • Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management
  • Work independently to carry out assignments with occasional support from senior management
  • Contribute to ongoing improvement of programming processes and methodology
  • Review closely CRF annotations and data specifications
  • Develop programming specifications based upon the study protocol and statistical analysis plan (SAP)
  • Apply CDISC standards for SDTM and ADaM specifications when applicable
  • Create persistent SAS datasets and table, figure, and listing outputs (TFLs) according to study specifications and Statistical Analysis Plan (SAP)
  • Perform validation programming for all programming deliverables
  • Develop SAS macros and utility programs for repeat use across projects

REQUIREMENTS:

  • Base SAS certification or the equivalent SAS programming experience, ideally in clinical trials and/or within a CRO context.
  • Ability to communicate well in written and spoken English
  • A commitment to working within a team and producing high quality results while working under timeline constraints.

EDUCATION REQUIREMENTS:

  • Bachelor’s degree (or higher) in Statistics, Computer Science, or other closely related field to programming
  • SAS Certification
  • 2+ years SAS programming preferred

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs identified by the company.

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Business Development Director

Business Development

Working within the Business Development department, the Business Development Director is responsible for driving the expansion and growth of the Trial Runners business and brand. This role promotes strategic growth by identifying leads; cultivates and fosters relationships with customers, suppliers, and other partners; and closes sales transactions to increase industry market share and generate company revenue.

RESPONSIBILITIES:

  • Identify new business opportunities including: new markets, growth areas, trends, customers, products and services
  • Seek out the appropriate contact in an organization
  • Generate leads and cold call prospective customers
  • Meet with customers/clients face to face or over the phone
  • Understand the needs of our customers, develop a plan for meeting these needs, and be able to respond back and communicate effectively
  • Think strategically - seeing the bigger picture and setting aims and objectives in order to develop and improve the business
  • Work strategically - carrying out necessary planning in order to implement operational changes
  • Manage data for new and prospective clients in CRM, prepare reports by collecting, analyzing, and summarizing information
  • Maintain quality service delivery by establishing and enforcing organization standards
  • Maintain professional and technical knowledge by attending educational workshops; review professional publications; establish personal networks; benchmark state-of-the-art practices; participate in professional societies
  • Meet individual sales goals in order to help Trial Runners and subsidiaries meet team and company sales goals
  • Attend and participate in industry conventions
  • Demonstrate high level of company service and product knowledge

REQUIREMENTS:

  • Outstanding written and verbal communication skills
  • Proficient in use of Microsoft Office Suite
  • Experience using CRM (Salesforce, Zoho, Oracle, etc.)
  • Frequent travel of up to 50%-75% during convention season
  • Frequently navigate stairs
  • Assistance with lifting/carrying/moving office supplies and shipment weighing 25 or more pounds
  • Assistance with set-up and take down of convention trade booth and materials

EDUCATION REQUIREMENTS:

  • Bachelor’s degree or additional sales experience above and beyond 3 years
  • Minimum 2-3 years sales experience, preferably in Business-to-Business (B2B)

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs identified by the company.

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Quality Assurance (QA) Manager (Contract) Part-Time

Clinical Development

Working within the Clinical Development Department, the Quality Assurance (QA) Manager is responsible for oversight, implementation, and maintenance of Trial Runners’ Quality Management System. This position drives the company’s ongoing focus of continuous quality improvement activities, within clinical service delivery, while operating within the framework of the company’s mission, vision, and policies. This role is responsible for oversight of inspection readiness audits, internal process audits and site audits, confirmation of the supplier/vendor, and system validations and represents Trial Runners during sponsor or FDA audits.

RESPONSIBILITIES:

  • Promotes an environment for continuous improvement within the organization and remains up to date with major regulatory trends within the industry.
  • Leads the continuous compliance and improvement of Trial Runners Quality Management System (QMS) in accordance with company policies, industry regulations, and sponsor requirements.
  • Writes, reviews, and coordinates the development of SOPs and WINs.
  • Performs quality reviews and provides input into clinical and non-clinical documents to ensure compliance with Trial Runners SOPs and regulatory requirements.
  • Assesses the Clinical Quality Assurance (CQA) audit program for areas of high risk to ensure they are addressed. Proactively flags and escalates potential issues to the CEO.
  • Reviews, assesses, and monitors regulatory inspections and sponsor audit commitments.
  • Serves as Quality Ambassador to the clinical team for a positive quality culture impact. Addresses employee and customer requests, complaints, and grievances according to established SOPs and policies.
  • Serves as liaison between external auditors/inspectors and Trial Runners Project Teams during external audits and inspections, serving as the subject matter expert (SME) on federal regulations, ICH GCP and institutional policies.
  • Leads inspection readiness activities and ensures project teams are prepared for regulatory inspections and sponsor audits

REQUIREMENTS:

  • Minimum of 6 years in clinical research field (preferably at a CRO), or high-level leadership positions that demonstrate qualifications.
  • Extensive knowledge of United States Code of Federal Regulations, ICH Guidelines. GCP and other government regulatory requirements governing clinical research.
  • Demonstrated leadership, training, and mentoring experience.
  • Demonstrated strong self-management skills: independently prioritize work, manage and prioritize multiple projects, excellent attention to detail, accuracy, and organizational skills.
  • Excellent verbal and written communication skills with a demonstrated ability to maintain confidentiality.
  • Excellent interpersonal communication skills: ability to lead cross-functional teams and while maintaining quality and being an advocate for regulatory compliance.
  • Excellent computer skills, with expert knowledge of Microsoft Office Suite programs; experienced in learning and navigating clinical data systems, and experience and comfort navigating and hosting remote web-based meeting systems such as Zoom, WebEx, Microsoft Teams, etc.

EDUCATION REQUIREMENTS:

  •  Bachelor’s Degree in Life Sciences or a related field, with significant relevant work experience required.

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs delegated by the company.

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Quality Control (QC) Coordinator (Contract) Part-Time

Clinical Development

Working within the Clinical Development Department, the Quality Control (QC) Coordinator is responsible for providing quality support to projects, in accordance with ICH/GCP guidelines and Trial Runners Standard Operating Procedures. Trial Runners Quality Control System encompasses continuous improvement through SOP/WIN/TMF review on a study wide, site level basis as well as a product control basis.

RESPONSIBILITIES:

  • Performs 3 types of QC Checks:
    • Study Wide Quality Control Check: A full project check based on the completion of a phase of trial conduct (set-up, start-up, enrollment, maintenance, and close out) to confirm that there is objective evidence to conclude that the phase of the project was completed and maintained in the TMF or CTMS.
    • Site level Quality Control Check: Site review of TMF documents. Sites will be reviewed once during the entire project and divided between phases of enrollment, maintenance and close out.
    • Document Control Quality Check: Using form ADM01-FRM-05, pivotal documents will be assessed for grammar and cleanliness prior to finalization. This includes, study plans, regulatory binder, procedure binder, ICF, protocols and CSRs.
  • Performs quarterly QC checks of staff training records within the company LMS.
  • Prepares and maintains quality control documentation.

REQUIREMENTS:

  • Knowledge of Code of Federal Regulations (CFRs), International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines.
  • Demonstrated strong self-management skills: excellent attention to detail, accuracy, prioritization of projects, and organizational skills.
  • Excellent verbal and written communication skills and a demonstrated ability to maintain confidentiality.
  • Excellent interpersonal communication skills: ability to work effectively and cohesively with cross- functional teams while maintaining quality and being an advocate for regulatory compliance.
  • Excellent computer skills, with expert knowledge of Microsoft Office Suite programs; experienced in learning and navigating clinical data systems, and experience and comfort navigating and hosting remote web-based meeting systems such as Zoom, WebEx, Microsoft Teams, etc.

EDUCATION REQUIREMENTS:

  • Minimum of a HS diploma. Bachelor’s Degree in Life Sciences or other scientific discipline is highly preferred
  • Previous experience within a clinical research setting or related field highly preferred

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs delegated by the company.

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Regional Monitor

Clinical Operations

Working within the Clinical Operations Department and the Clinical Project Management functional area, the Regional Monitor will apply professional knowledge and skills in implementing clinical trials in accordance with ICH/GCP guidelines and Trial Runners Standard Operating Procedures, with particular emphasis on site monitoring. They will serve as primary liaison between Clinical Project Teams and the investigative sites, focusing on site management activities.

RESPONSIBILITIES:

  • Monitor activities at assigned investigative sites; conduct Pre-Study, Study Initiation, Interim monitoring, and Close-Out visits, ensuring that the site is in compliance with the clinical investigation plan and ICH/GCP guidelines.
  • Ensure safety at investigative sites by verifying proper recording and reporting of Serious Adverse Events (SAEs).
  • Perform investigative site file reconciliation of the regulatory binder, eTMF and query resolution; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements.
  • Complete monitoring trip reports, confirmation, and follow up letters for all monitoring visits, within the appropriate and designated timeframes for each.
  • Participate in development, review, and implementation of project study procedures and regulatory binders.
  • Responsible for coordinating input from Clinical Study Team to resolve site-specific issues.
  • Assess site training needs and organize/recommend appropriate training at the investigational site level.
  • May participate in database user acceptance testing (UAT) to ensure parameters and edit checks are performing as expected.
  • Negotiate site contracts, budgets, and own the site invoicing and overall site budget management.
  • Performs data review of patient profiles and listings.

REQUIREMENTS:

  • Verifiable experience in Ophthalmology and/or rare disease highly preferred.
  • Working knowledge of FDA and International Conference of Harmonization and Good Clinical Practices (ICH/GCP) Guidelines
  • Excellent oral and written and communication skills
  • Strong attention to detail and accuracy
  • Strong operational, organizational, presentation, documentation, and interpersonal skills
  • Ability to travel up to 75%, as needed to support project requirements.
  • Expert level computer skills – Excel, Word, PowerPoint, Microsoft Outlook, and experienced with clinical trial database systems.

EDUCATION REQUIREMENTS:

  • Bachelor’s Degree in Life Sciences related field required (significant relevant work experience may be considered).
  • Minimum 2 years clinical research industry experience.

NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as assigned to meet the ongoing needs identified by the company.

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General Resume Submission

Please use this link to submit a CV/Resume for a position you don't see currently listed. We will keep your CV on file and contact you if an opening should occur.

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