Open Roles

At Beacon Therapeutics (USA) Inc, we are excited to offer a fully remote Clinical Documentation Specialist position that invites experienced professionals to elevate their careers in a forward-thinking biotech environment. Imagine being part of a collaborative team that values transparency and accountability while making remarkable advancements in the healthcare sector. This role allows you to work from your home located on the East Coast.

The compensation for this position is commensurate with your experience and education, ensuring that your skills are recognized and rewarded. Join us in a diverse workforce that champions continuous improvement and integrity. This is an opportunity to contribute meaningfully to innovative projects that truly make a difference.

As a team member you’ll be able to enjoy benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, Paid Time Off, Employee Discounts, and Employer paid STD and LTD. We look forward to your application and the chance to grow together in this exciting role.

If you are passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We are a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.

As a Clinical Documentation Specialist at Beacon Therapeutics (USA) Inc, you will play a crucial role in managing the electronic Trial Master File (eTMF) documents essential for clinical trials. Your responsibilities will include uploading, organizing, and indexing these critical documents within the eTMF system, ensuring compliance and quality through meticulous document reviews for regulatory adherence and accuracy. You will perform quality checks to confirm completeness and resolve any discrepancies that may arise. By collaborating closely with cross-functional teams, you will ensure timely and accurate document submissions, while also providing support and training to team members as needed.

This position is vital for maintaining the integrity of our clinical trial processes and fostering a culture of excellence within our organization.

To excel as a Clinical Documentation Specialist at Beacon Therapeutics (USA) Inc, candidates must possess a robust understanding of regulatory requirements, such as ICH-GCP and 21 CFR Part 11. Proficiency with eTMF systems for managing clinical trial documents is essential, as is a deep familiarity with eTMF standards, the CDISC TMF Reference Model, and Good Document Practices (GDP). A keen attention to detail is necessary for ensuring accurate documentation and conducting thorough quality control audits to verify completeness and accuracy.

Strong communication skills will facilitate effective collaboration with cross-functional teams, while problem-solving and time management abilities will help you thrive in a dynamic work environment. Together, these skills will empower you to contribute significantly to our mission of advancing healthcare through innovative clinical practices.

Knowledge and skills required for the position are:

• Knowlege of regulatory requirements e.g. ICH-GCP 21 CFR Part 11
• Experience with eTMF systems for managing documents
• Strong attention to detail for accurate documentation
• eTMF Standards CDISC TMF Reference Model
• GDP and document management
• Quality control auditing documents for accuracy and completeness
• Strong attention to detail
• Excellent communication skills
• Problem solving and time management skills

So, what do you think? If you feel this is the right job for you, go ahead and apply! We look forward to meeting you!

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.