Clinical Trial Assistant

About Ikena
Ikena Oncology is a clinical-stage biotechnology company that discovers and develops patient-directed, biomarker-driven therapies for cancer patients who need life-saving treatment, by understanding what drives their disease. Ikena is advancing five clinical, preclinical, and discovery programs. Ikena has entered into a global strategic collaboration with Bristol Myers Squibb and raised capital from top tier investors OrbiMed Advisors and Atlas Venture.

Role Description
Ikena Oncology is seeking a highly talented and motivated Clinical Trial Assistant (CTA) to join an innovative, scientifically minded, fast paced clinical team. The CTA will be responsible for supporting development programs for multiple investigational drug products. The CTA provides a key support function to the clinical operations team with study-related operational tasks. The CTA will report to the Director of Clinical Operations.

Responsibilities

  • Supports the clinical team in the overall management of studies, including planning, execution, and closeout of multiple clinical trials
  • Manages the Trial Master File according to Sponsor Oversight plan to ensure accuracy, completeness, and current
  • Creates and maintains study trackers (e.g., contact lists, study status trackers, enrollment) and project files
  • Assists the clinical team with maintenance and tracking of PO requisitions and invoices
  • Tracks metrics related to Sponsor Oversight; works closely with CRO monitoring staff, reviews site/patient activity tracking, reviews monitoring reports and proactively identifies and solves study-related issues
  • Reviews all essential regulatory documents prior to site initiation and Investigational Product release
  • Assists in tracking investigational product supplies at the trial site level, keeping sites informed of trial supplies including drug lots/batches and expiration dates
  • Assists with safety data monitoring such as tracking of SAEs and reporting to collaborators
  • Provides support in reviewing study documents (e.g., site ICFs, IBs, protocols, regulatory documents, SIV slides, etc.) to ensure quality and consistency
  • Assists the clinical team in tracking and distribution of Sponsor study documents (e.g., protocols, administrative letters, and pharmacy manuals) to clinical research organization (CRO) and study sites if applicable
  • Assists with the management of tracking and logistics for biological samples supporting clinical trials from collection to analysis to help ensure that sample inventories are accurate, complete, and up to date
  • Participates in vendor selection and management meetings (e.g., CROs, IVRS, Central Labs, etc)
  • Supports the clinical team with coordination and preparation for investigator meetings, PI calls, conferences as well as internal clinical meetings
  • Supports with other study-related administrative tasks (scanning, emailing, filing, shipping, etc.)


Qualifications

  • BA/ BS degree or equivalent work experience in lieu of a degree
  • 1-3 years of clinical research experience in a pharmaceutical, academic, hospital or CRO setting
  • Excellent computer skills (Microsoft Office Word, Excel, Outlook)
  • Experience working with essential regulatory documents and specifically Trial Master File organization and structure
  • Self-motivated and able to work in a small team environment; able to independently identify tasks/issues that need to be addressed
  • Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines
  • Prior experience working in lab is a plus

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 obstacles.

Application Form

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