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FirstString Research is a clinical stage biotechnology company founded on a vision to deliver clinically relevant and effective solutions for inflammation-based medical conditions through an understanding of the molecular and cellular contexts that define the underlying pathology. Our focus is on diseases with unmet medical needs associated with dysregulation of inflammatory processes and an impaired injury response.

FirstString is a high growth, fast paced organization that offers competitive salary and benefits including 401k to employees at all levels. We are currently seeking highly motivated, self-driven individuals to join our team. The ability to be productive and successful in an intense work environment is critical.

Please send a resume and cover letter to info@firststringresearch.com

Senior Director of Clinical Operations

The Senior Director of Clinical Operations will be a key leader in strategic planning, oversight, and operational management of FirstString Research’s clinical trial portfolio. The Senior Director of Clinical Operations will work across multiple functions to ensure operational trial deliverables are completed according to established timelines, budget, operational procedures, quality standards, and in compliance with applicable ICH/GCP regulations. This includes developing and overseeing clinical operational plans aligned with corporate strategy and R&D objectives; close communication and collaboration with contract research organizations (CROs), clinical sites, and/or vendors; study budget management; trial timeline management; development of clinical trial designs with insight from key opinion leaders; and quality assurance of clinical data. The Senior Director of Clinical Operations will provide oversight and strategic guidance to FirstString’s clinical operations team and will work closely and collaboratively with other senior and functional leaders to ensure harmonized and integrated development strategies to drive portfolio prioritization.

Ideal candidates have a background in the biotechnology/pharmaceutical industry, with strong leadership skills and a proactive drive to develop and improve consistent project management excellence to achieve clinical trial deliverables.

Key Essential Functions:

  • Organize and oversee activities of FirstString’s clinical operations staff and vendors/service providers involved in the conduct of assigned clinical trials
  • Proactively identify hurdles or challenges in study conduct/management and provide efficient, innovative solutions and mitigation strategies in collaboration with Executive/Senior Management
  • Lead the development and contribute to the preparation of relevant study documentation including clinical protocols, operational study plans, statistical analysis plan, clinical study reports, etc. Review and refine clinical operational plans as needed.
  • Lead and oversee CROs and external vendors to conduct clinical trials at the highest quality and within established timelines and budgets
  • Communicate project objectives and deliverables with clinical sites and CROs
  • Maintain regular contact with CROs and external vendors to assess performance and provide guidance as needed
  • Develop and manage study timelines (including recruitment)
  • Identify talent and resource gaps – responsible for performance management of clinical operations staff
  • Oversee FDA regulatory submissions

Qualifications:

  • Bachelor’s degree or advanced degree in health sciences or related discipline. Advanced degree is desirable.
  • Minimum of 10 years relevant clinical research experience in biotechnology/ pharmaceutical industry or CRO. Background in biotechnology or pharmaceutical industry preferred, but not required.
  • Minimum of 5 years upper level management and relevant supervisory experience
  • Strong experience in vendor management, leading CROs/contracted resources, site monitoring, clinical quality compliance, and managing clinical trial budgets
  • Demonstrated experience in clinical operations development and strategic planning, as well as experience in early to late-stage clinical trials
  • In-depth knowledge of the drug development process (IND to NDA), including FDA regulations and expectations
  • Excellent working knowledge of clinical SOPs, GCP, and ICH guidelines
  • Demonstrated ability to successfully manage multiple projects with equal priority
  • Well-honed leadership and organizational skills, capable of leading by example, thrive on increasing levels of responsibility, proactively and confidently moves the business forward, sense of urgency to meet pressing deadlines in a fast-paced environment, uses insightful and critical thinking to optimize operational management of clinical trials
  • Dedicated team player, displays positive attitude, directly contributes to team efforts, and builds strong relationships with a wide range of stakeholders, both internally and externally, at all levels (e.g. Executive/Senior management, KOLs, CRO team members, cross-functional team members, etc.)
  • Detail and quality oriented with demonstrated track record of successfully meeting project deliverables within established deadlines, budget, and allocated resources

 

Clinical Research Quality Specialist (contract basis)

FirstString Research, Inc. is looking for a motivated team player to help expand our clinical research quality efforts by developing SOPs, creating training plans, and aiding in the implementation of document management software.

  • This is a full time, contract position for a minimum of 3 months with potential to extend.
  • The Clinical Research Quality Lead reports to the Director of Clinical Operations.
  • This is a remote position – relocation not required.

Key Essential Functions:

  • Work closely with the clinical trial team to determine the quality needs
  • Analyze and interpret applicable regulations
  • Create, edit and QC SOPs for clinical trial processes
  • Develop training plans to properly implement approved SOPs
  • Lead training, where appropriate, and maintain training records
  • Assist with the implementation of eTMF and other document management tools
  • Lead other clinical quality efforts as needed
  • Assist with software validation as needed

Qualifications:

Minimum Requirements

  • Bachelor’s degree
  • 5+ years of Clinical Research Industry (BioTech, Pharma, or CRO) experience, preferably within Regulatory, Quality Assurance, or Medical Writing
  • Experience creating, editing, and implementing SOPs
  • ICH-GCP Certification (current with documentation)
  • Experience with TMF processes and utilization of an eTMF system
  • Excellent written and verbal communication skills
  • Exceptional organization and time management skills
  • Ability to work independently
  • Adverse Event Reporting processes
  • Familiarity with medical terminology

Preferred Experiences

  • Experience in a small, startup company environment
  • Experience with software validation
  • Advanced knowledge of clinical monitoring, project management, data management, and study start-up processes
  • Familiarity with Audit Processes and CAPA implementation

 

Clinical Trial Lead

The Clinical Trial Lead (CTL) works independently on most assignments. The ability to multitask, prioritize, and identify tasks/issues that need to be addressed while being highly organized is a must.

The CTL assists the study team across all study sites and ensures compliance with clinical trial protocols and overall clinical objectives. This position incorporates project/study management-related responsibilities by coordinating and tracking activities for clinical trials and regulatory functions/reporting from the inception of the study through database lock.  The successful candidate must be able to work closely with all functional areas to ensure high-quality study outcomes.

Note: This is not a remote position.

Key Essential Functions:

  • Initiate, provide guidance, and ensure study activities are executed according to clinical trial protocol, regulatory guidelines and operational project plan.
  • Create and review protocols, electronic case report forms, informed consent forms, and other study materials that reflect a thorough understanding of the study drug and procedures.
  • Keep abreast of standard operating procedures (SOPs), Good Clinical Practice (GCP) and ICH guidelines as well as relevant state and federal laws and ethical standards
  • Participate in study start-up, conduct and closeout activities
  • Initiate vendor requests for proposals and track receipt of proposals, coordinate proposal presentations and demonstrations, and preparation and review of MSAs and SOWs
  • Collect and review site regulatory documents for accuracy and completion (i.e. Form 1572, Financial Disclosure documents, CLIA waivers, etc.)
  • Create, assemble, and distribute regulatory binders and lab manuals to clinical sites
  • Draft and/or assist with preparation of trial-related documents and procedure manuals, source documents, tools and templates (start-up forms, study logs)
  • Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across study sites and maintaining study-status trackers.
  • Maintain/monitor the electronic Trial Master File for clinical trial projects

Qualifications:

  • Bachelor’s Degree
  • Relevant experience in the pharmaceutical, biotechnology, academic or contract research organization (CRO) setting preferred
  • Working knowledge of clinical SOPs, GCP, and ICH guidelines
  • Excellent written and verbal communication skills
  • Strong PC skills (MS Word, MS Excel, MS Project, Sharepoint)
  • Sound analytical and problem-solving skills
  • Detail and quality oriented
  • Working knowledge and experience with Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), and Clinical Trial Monitoring Systems (CTMS)
  • Exceptional organizational and time management skills, ability to work independently

 

Administrative Assistant

The Administrative Assistant will be responsible for providing administrative support to management and will perform general clerical duties as needed. The ability to multi-task while maintaining multiple schedules and deadlines is essential to this position. The ideal candidate is efficient, resourceful, motivated to help others, able to work independently, a good problem solver, and well organized. Assuring steady completion of the workload in a timely manner is important to success in this position.

Note: This is not a remote position.

Key Essential Functions:

  • Perform clerical tasks and other projects as directed by management and see tasks/projects through completion
  • Organize/schedule meetings and appointments
  • Maintain online calendars for executive management, keeping track of deadlines and meeting dates, and setting reminders for upcoming appointments
  • Generate correspondence memos, emails, letters, and reports when appropriate
  • Schedule travel and meeting arrangements
  • Maintain electronic and hard copy filing systems
  • Perform data entry
  • Assist in the preparation of presentations and spreadsheets
  • Prepare agendas and other materials for meetings
  • Assist with bookkeeping duties
  • Assist in the preparation of regularly scheduled reports
  • Answer incoming calls when necessary
  • Maintain office supply inventory and supply ordering
  • Run out-of-office errands as needed

Qualifications:

  • Bachelor’s degree preferred
  • Detail oriented and comfortable working in a fast-paced office environment
  • Superior organization and time management skills
  • Ability to prioritize work
  • Self-starter who works well independently
  • Exceptional communications skills
  • Ability to analyze and revise operating practices to improve efficiency
  • Proficiency in Microsoft Office with particular expertise in Microsoft Word, PowerPoint, and Excel
  • Excellent written and verbal communication skills