Summer , Clinical Operations - Remote

ZipRecruiter; Cambridge; Remote; GBP 20,000 - 30,000; Full time

Job summary

An innovative firm is seeking a Clinical Operations Intern for a remote summer program focused on understanding clinical trials in ophthalmology. This role offers a unique opportunity to gain operational knowledge while supporting the Clinical Operations team in managing clinical study documents and compliance. Interns will engage in various tasks, from maintaining essential tracking tools to attending site visits, providing a comprehensive insight into the clinical trial process. Ideal candidates are detail-oriented students in their third year or beyond, eager to learn and contribute to impactful projects within a dynamic environment.

Qualifications

• Currently enrolled in a relevant undergraduate or graduate program.
• Strong attention to detail and organizational skills are essential.

Responsibilities

• Support the Clinical Operations team with clinical study documents.
• Assist in maintaining the Trial Master File and compliance with regulations.

Skills

Attention to detail

Organizational skills

Communication skills

Time management

Proficiency in Microsoft Office Suite

Proficiency in SharePoint

Education

Undergraduate or graduate degree in Science, Engineering, or Business

Tools

Microsoft Office Suite

SharePoint

Job description

Mission

The Clinical Operations Summer internship is a remote position focused on understanding the role of clinical operations in initiating and managing clinical trials within ophthalmology. Interns will gain operational knowledge of current clinical trials at Beacon Therapeutics and apply this knowledge to initiate and track clinical site activities and related documentation.

2025 Program Dates (choose one):

• 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

• Support the Clinical Operations team in reviewing, maintaining, distributing, and archiving clinical study documents and reports.
• Assist with maintaining the Trial Master File (TMF) in compliance with ICH, GCP, and company SOPs, including review and tracking of documents with vendors and CRO.
• Update the Essential Document Tracker promptly, ensuring study and site documents are filed within the TMF upon receipt.
• Create and maintain internal tracking tools for managing studies and sites.
• Review clinical study data and generate queries to ensure timely and accurate completion by study sites.
• Attend at least one site visit to reconcile site documents in the TMF against Investigator Study Files (ISF).
• Participate in company meetings, clinical operations meetings, and other relevant meetings.
• Hold weekly 1:1 meetings with mentors or supervisors.
• Assist with special projects or tasks as needed.
• Work Monday through Friday, 8 am to 5 pm, with a 1-hour lunch, not exceeding 40 hours per week. This is a seasonal, unpaid internship.
• Note: Job responsibilities may change over time.

Travel Requirements

• Up to 5% domestic travel may be required.

Educational Qualifications

• Currently enrolled undergraduate or graduate student, at least in their third year, pursuing a degree in Science, Engineering, or Business.

Additional Qualifications

• Attention to detail, good planning and organizational skills.
• Ability to maintain confidentiality.
• Proficiency with Microsoft Office Suite and SharePoint.
• Excellent written and oral communication skills, along with effective time management.
• Ability to multitask under tight deadlines across multiple projects.

Physical Requirements

• Primarily indoor work, sitting for extended periods with repetitive motions.