Boston, MA

Position: Clinical Document (Associate-Specialist)

Position Summary

This critical position reports to the Director/Sr. Director Clinical Operations. This is a key role in providing support and oversight of the Trial Master File (TMF).

Responsibilities

• Ensures all documents are accurately processed in the eTMF in a timely manner.
• Responsible for deliverables related to the eTMF as outlined in the study specific TMF Plan.
• Internal document processing activities for upload to the CRO Master TMF as well as internally held TMF Documents.
• Assists with expected document list (EDL) management.
• Identifies process and quality improvement needs, supports and/or facilitates the implementation of necessary changes, including system enhancements, as required.
• Supports and drives the continuous improvement and inspection readiness initiatives for assigned studies.
• Reviews essential documentation upon submission to the TMF for legibility, completeness and appropriate identifiers for studies assigned.
• Responsible for coordinating with project teams to ensure all eTMF are set-up and maintained according Karuna’s SOPs and WGs.
• Assists study teams in filing and maintaining TMF.

Required Qualifications

• Associate’s/Bachelor’s Degree with at least 1+ year of TMF / eTMF experience and document management or a minimum of 4 years of experience in clinical research, TMF / eTMF experience, and document management.
• Knowledge of ALCOA document standards.
• Experience with ICH GCP e6 (R2) / GCP regulations, and DIA Reference module.

• Previous TMF/eTMF Oversight Responsibilities, preferred.
• Experience in Veeva Vault Clinical preferred.
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others.
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required.
• Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company.
• Forward thinking mindset with the ability to manage multiple projects, and identify and resolve issues.
• Broad experience in an emerging, publicly traded company environment is a plus.

The successful candidate will also embody our values:

Our purpose is to create value for those we have the privilege to serve:

• We take pride in our work
• We keep our promises and deliver
• We are driven to meaningfully innovate
• We succeed through inclusion and teamwork

Karuna Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Karuna Therapeutics requires all employees be fully vaccinated by an approved vaccine against COVID-19, including a booster dose if it has been more than eight months since the employee’s original vaccination, unless you need an exemption due to disability, pregnancy or conditions related to pregnancy or religion or unless otherwise provided by law; in the case of exemption, weekly testing will be required.