Clinical Research Assistant

Job Title:

Clinical Research Assistant

Job Description

The Clinical Research Assistant provides comprehensive administrative and operational support to a centralized research services team, ensuring smooth coordination of clinical trials, accurate financial and regulatory documentation, and timely communication across internal and external stakeholders. This role plays a key part in managing study intake, supporting contract execution, monitoring training and compliance, and preparing performance metrics that help optimize the overall research program.

Responsibilities

+ Track messages and schedule appointments using the shared RSS inbox and calendar in Outlook, ensuring that communications are routed or escalated promptly to the appropriate team members.

+ Assist in the management and preparation of Confidentiality Disclosure Agreements between the site and Sponsors or CROs, and organize and coordinate other related administrative agreements.

+ Support the RSS team and leadership by scheduling meetings and conference rooms, recording meeting notes and action items, and providing regular updates on the status of those items.

+ Support new study intake from initial study award through contract execution, including facilitating internal study review meetings.

+ Apply critical thinking skills to evaluate pre-award and post-award communications, determine whether actions are required, and identify potential impacts on studies and processes.

+ Demonstrate understanding of the relationship between study essential documents such as Clinical Trial Agreements (CTA), protocols, informed consent forms (ICF), and budgets, and assist with reconciliation needed for CTA execution.

+ Maintain familiarity with the sites Clinical Trials Management System (CTMS) and provide support for administrative updates and data integrity.

+ Coordinate routine reminders to track and manage central staff training and curriculum vitae (CV) expiration dates, ensuring timely renewals.

+ Partner with leadership to prepare and execute onboarding tasks for new RSS staff, helping to ensure a smooth transition into the research program.

+ Review protocol amendments to determine whether changes affect coverage analyses, Clinical Trial Agreements, budgets, and ERDs, and communicate findings to relevant stakeholders.

+ Collaborate with the Director for Research to collect Key Performance Indicators (KPIs) for all research sites and teams.

+ Prepare data and metrics related to department turnaround times, and compile and analyze monthly, quarterly, and annual reports and metrics for the department.

+ Identify issues and opportunities for process improvement and present well-considered resolution ideas to the team or leadership.

+ Serve as a liaison between internal and external partners and the RSS team, responding to questions and coordinating requests.

+ Work with relevant departments to obtain current Certificates of Insurance, W-9 forms, Fair Market Value physician rates, and other required documents, ensuring they are properly filed and shared with appropriate team members.

+ Review patient visits and procedures across platforms such as CTMS, EPIC, and Outlook to ensure compliance, accuracy, and consistency.

+ Complete a comprehensive review of 100% of charges that drop in EPIC for research participants to ensure proper billing and compliance.

+ Reconcile EPIC transaction reports and work queues to maintain accurate financial records for research activities.

+ Complete assigned tasks efficiently and on time while maintaining high standards of quality and attention to detail.

+ Embrace stretch projects and new tasks as opportunities for learning, skill development, and personal growth.

+ Participate in ongoing efforts to centralize and optimize the research programs processes and infrastructure.

Essential Skills

+ Prior clinical research administrative experience is required.

+ Prior clinical research experience, with 2 or more years strongly preferred.

+

Experience with research finance and regulatory documents is strongly preferred.

+ Up to 2 years of experience related to insurance billing, administrative support of clinical trials, EPIC use, regulatory work, or basic accounting; a combination of these experiences will be considered.

+ Proficiency in using Outlook for shared inbox and calendar management.

+ Ability to work with Clinical Trials Management Systems (CTMS).

+ Experience reviewing and reconciling patient visits, procedures, and charges across systems such as CTMS and…