Clinical Research Associate

About Ikena
Ikena Oncology (NASDAQ: IKNA) is a targeted oncology company focused on developing cancer therapies targeting key signaling pathways that drive the formation and spread of cancer. Ikena is advancing five programs that include four product candidates in either clinical development or IND-enabling studies and has a global strategic collaboration with Bristol Myers Squibb.

Role Description
The Clinical Research Associate (CRA) will work on studies for one or more of our lead programs, providing support to study management in collaboration with the Sr. Clinical Trial Manager. The CRA is expected to process and perform quality assurance checks of clinical trial data to ensure data integrity and consistency across clinical programs and in accordance with Ikena’s standard operating procedures and Good Clinical Practices (GCP).

Responsibilities

  • Performs verification and quality control of essential regulatory documents and is well versed in the organization of a trial master file
  • Co-monitors the study sites with the assigned CRAs as required per the Sponsor Oversight Plan or as needed
  • Maintains study-specific tracking tools and project files
  • Assists in managing investigational product supplies, keeping sites informed of drug lots/batches and expiration dates. Ability to review and perform drug accountability if required
  • Develops and maintains an adequate level of scientific knowledge within the Project’s therapeutic area
  • Contributes to the site identification and selection process
  • Takes an active role in development and review of study documents, such as informed consent forms, study logs, study manuals and guidelines, including study monitoring plans
  • Tracks metrics related to sponsor oversight and the Monitoring Plan; works closely with CRO monitoring staff, reviews site/patient activity tracking, prepares study updates and proactively identifies and solves study-related issues
  • Reviews Monitoring Visits Reports and tracks resolution of all action items related to CROS
  • Participates in the set-up of the clinical database (UAT testing)
  • Tracks and distributes study specific documents such as operational, pharmacy, and lab manuals to CRO and study sites if applicable
  • Contributes to the development of department processes and best practices
  • Participates in the training, review, and refinement of Standard Operating Procedures (SOPs) and the development of standard reports, templates, and forms
  • Participates in the selection of vendors including contractors, and CROs, and assists with plan development, and management/oversight of vendor. May serve as the primary project contact for communication and coordination for the third-party vendors
  • Assists with contract and budget preparation, negotiations, and management
  • Performs clinical data listing reviews for completeness and accuracy; identifies issues related to monitoring and/or data entry and escalates as needed


Qualifications

  • B.S. degree or equivalent in a health science field and at least 3 years of on-site clinical research monitoring experience through a clinical research organization (CRO) or pharmaceutical company
  • Strong communication and interpersonal/team skills
  • Experience managing clinical studies using Electronic Data Capture systems
  • Sound working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines and other applicable regulatory guidelines required
  • The candidate will be detail-oriented and can both prioritize and handle multiple tasks effectively in a small company environment
  • Established ability to prioritize and manage multiple tasks simultaneously
  • Demonstrate ability to identify and resolve issues, and effectively manage timelines
  • Strong initiative and a can-do attitude, excellent organizational skills, proven effectiveness in a fast-paced environment

Personal attributes: team oriented, goal-driven, organized, highly collaborative, open-minded, data-driven, creative, persistent in the face of obstacles and uncertainty, flexible, self-aware of strengths and weaknesses, objective in the evaluation of data and strongly optimistic about overcoming challenges.

Application Form

Our supportive work environment fosters creative thinking and freedom of expression.