Summer Internship, Clinical Operations

Mission

The Clinical Operations Summer Intern will be a remote position working on understanding the role of clinical operations in initiating and managing clinical trials within ophthalmology. The intern will be expected to gain operational knowledge regarding current clinical trials at Beacon Therapeutics and apply learnings towards initiating and tracking of clinical site activities and associated clinical documentation.

2025 Internship Program Dates (one of the following options):

• • Tuesday, May 27 - Friday, August 15
  • Monday, June 2 - Friday August 22

Reporting Relationship

• The Clinical Operations Intern will report to the Senior Clinical Operations Manager or designee.

Duties and Responsibilities

• Supports the Clinical Operations team in the review, maintenance, distribution, and archiving of clinical study documents and reports.
• Supports the Clinical Operations team in review, maintenance, distribution, and archiving clinical study documents and reports.
• Assists with the maintenance of the Trial Master File (TMF) in compliance with ICH, GCP and the Company's SOPs. This may include the review and tracking of clinical trial documents in coordination with vendors and the CRO.
• Updates the Essential Document Tracker in a timely manner ensuring study and site documents are filed within the TMF upon receipt.
• Assists in the creation and maintenance of internal tracking tools used to manage assigned studies/sites.
• Reviews clinical study data and generates queries to ensure timely and accurate completion by study sites.
• Attend one site visit to reconcile site documents maintained in the TMF against the Investigator Study Files (ISF) located at study sites.
• Will attend company meetings, clinical operations meetings, and any other meetings as needed.
• Will attend 1:1 weekly meeting with mentors/supervisor.
• Assisting with special projects and/or tasks, as required.
• Intern will be expected to work M-F, 8 am to 5 pm with a 1-hour lunch break, not to exceed 40 hours per week. This is a seasonal position and is not eligible for benefits.
• This job description is subject to change at any time.

Travel Requirements

• 5% of domestic travel required

Educational Qualifications

• A currently enrolled undergraduate or graduate university or college student that has completed at least their third year working towards a Science, Engineering or Business degree.

Additional Qualifications

• Attention to detail; good planning and organizational skills.
• Ability to maintain confidentiality.
• Experience with Microsoft Office Suite and SharePoint (preferred).
• Excellent written and oral communication skills, as well as time management skills.
• Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements.

Physical Requirements

• Working conditions indoors primarily stationary sitting for extended periods of time with repetitive motions.