Clinical Trial Associate (CTA)/Senior Clinical Trial Associate

Full-Time, Exempt

About Codagenix:

Codagenix Inc. is a clinical-stage synthetic biology company that uses software to recode the genomes of viruses, constructing live-attenuated vaccines or viruses to prevent viral infections or treat solid tumors. Codagenix’s recoded vaccine candidates are a perfect antigenic match to the target virus and induce a robust immune response to all viral antigens. Our nimble platform allows us to turn a virus into a potential prophylactic vaccine.

Codagenix is seeking a hands-on, dynamic individual with prior industry experience who will help build clinical operations infrastructure within the company and support multiple clinical studies in infectious diseases and oncology. The successful candidate will bring efficient  project execution strong communication and strategic problem solving perspective to a dynamic and growing portfolio of clinical research.

Responsibilities:

Primary responsibilities include but are not limited to:

  • Assist the Program Managers in the day-to-day activities of assigned clinical trials to ensure goals and timelines are met with quality, in compliance of SOPs and regulatory guidelines
  • For outsourced projects, the CTA will work with PM to oversee and monitor Clinical Research Organization (CRO) performance for all contracted services
  • For projects insourced, the CTA will work with the PM to help support the internal team with daily activities, conducted according to all applicable regulations and internal processes
  • Generate and distribute status reports to management and other clinical team members, proactively and as requested
  • Assist PM in collection of relevant study information on timelines, progress and resources
  • Assist in the development and tracking of clinical trial documents, tracking and management of clinical supplies. Follow-up on missing/incomplete/invalid documents
  • Based on study requirements, may coordinate the production and distribution and the reconciliation of study materials (Operations Manual, ISF, patient cards, etc.)
  • Maintain the Trial Master File (TMF) with supervision from Clinical Operations Lead
  • Conduct Trial Master File (TMF) oversight quality review & maintenance
  • Provide support in Program Level, and Clinical Trial meetings such as working with the PM to develop meeting agendas and PowerPoint slides, taking and distributing meeting minutes, and following up on action items.
  • Complete assigned tasks in accordance with SOPs and guidelines, Good Clinical Practice (GCP), International Council on Harmonisation (ICH) guidelines and regulatory requirements for clinical trial management.
  • Provide progress updates and summaries. Communicate study-related information to vendors as appropriate.
  • Assist in the management of CRO/Vendors to ensure deliverables are met with quality per contracted scope of work and in compliance with ICH/GCP and regulatory guidelines.

Requirements:

  • Minimum 2 years, 5 years preferred, prior experience in clinical research
  • Working knowledge of Trial Master File maintenance.
  • Ability to manage several ongoing projects, escalate and prioritize. Strong preference for experience with smaller pharmaceutical firms, or demonstrated ability to work (virtually) as part of a small team with limited resources and support
  • Excellent computer skills (Microsoft Office Suite) and the ability to adapt and learn new systems
  • Familiarity of ICH/GCP
  • Ability to build work with cross-functional team members internally and with vendors/consultants
  • Exhibits a high level of professionalism, self-motivated, comfortable with shifting priorities and willingness to adapt in fast pace environment
  • Full-time, Standard work schedule M-F 8:30-5:00PM EST, with some evening hours to support overseas trials.
  • International clinical trial experience preferred.
  • Domestic travel may be required 1-2x/year for meetings or trial support activities

Apply:

To apply, please send CV and cover letter to [email protected]

Note: Candidates for this position must be currently authorized to work in the United States on a full-time basis, and Codagenix will not sponsor applicants for work visas. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Codagenix is an equal opportunity employer and values diversity. All employment decisions are made on the basis of qualifications, merit and business need.

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