Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening disease. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins of proteins as drug targets.

Position Summary

This 10-week summer intern program will provide the intern (undergraduate student) an opportunity to participate in a highly interactive industry-based internship within the Clinical Operations Department. The Clinical Operations intern will provide general study management support to the Clinical Operations team.

Key Responsibilities

• Assists with the development of Standard Operating Procedures (SOPs)
• Creates business process workflows and study management job aids
• Maintains an SOP Glossary of Terms
• Assists with the preparation and review of trial-related documents, tools, templates, and trackers
• Maintains study trackers and logs, i.e., study site start-up status and regulatory submission documents
• Performs study start-up activities, i.e., site feasibility, document collection and review, follow-up with Contract Research Organizations (CROs)
• Reviews study documents, i.e., site-specific informed consent forms (ICFs) and monitoring trip reports
• Generates reports and dashboards, i.e., training completion reports from the Quality Management System (QMS), trial master file maintenance reports from the electronic Trial Master File (eTMF), dashboard of actual vs expected TMF document counts
• Following-up on overdue items
• Prepares system-related workflows and User Acceptance Test (UAT) test scripts
• Participating in system related UATs
• Provides support for project-related meetings, i.e., scheduling, room set-up, generating and distributing meeting materials
• Understands and adheres to regulatory requirements, ICH Guidelines, and Standard Operating Procedures
• At the conclusion of the internship, presents a summary of experiences gained during the tenure with Eikon Therapeutics

Qualifications & Experience

• Currently enrolled in university, pursuing a Bachelor's in Biology, Chemistry, Pharmaceutical Sciences, Immunology, or another science-related field.
• Have completed 2 years of study in the above listed fields.
• Must be enrolled in university during the internship program.
• Deadline-driven with a high level of organizational and planning skills.
• Strong problem-solving, oral, and written communication skills.
• Ability to work well in teams, effectively manage projects, and present ideas clearly and concisely.
• Strong computer skills (MS Office).

The expected salary range for this role is $30/hour to $40/hour depending on skills, competency, and the market demand for your expertise.