Clinical Trial Associate

Overview

The Clinical Trial Associate will be a core member of the Clinical Operations team providing support for activities related to clinical studies (Phase I-IV, PASS, PAES, Registries, ISS) and day-to-day organizational activities within RRD including Clinical Operations, outside vendors, and clinical trial sites, where applicable.

Essential Duties and Responsibilities

The Clinical Trial Associate leads the day-to-day activities associated with the operational and tracking aspects of running studies, freeing up the Clinical Study Managers and other Clinical Operations team members to focus on study execution and oversight. More specifically:

• Maintains accurate and organized records of clinical trials, participant data, and other relevant documentation within the Veeva Clinical Trial Management System (CTMS), Trial Master Files (TMF), SharePoint/ShareFile sites, and other utilized systems.
• Ensures that all documentation complies with regulatory guidelines, internal protocols, RRD SOPs, and study plans (monitoring, data review, etc.).
• Helps coordinate protocol amendments and updates, ensuring all team members are informed of changes, arranging meetings to discuss amendments, supporting the CTMs with documentation and follow-up while interacting with Global teams related to protocol activities or questions.
• Coordinates the logistics of clinical trial activities and documentation pertaining to site initiation visits, monitoring visits, and site closure visits within VEEVA CTMS and TMF.
• Stays updated on relevant regulations and guidelines in clinical research and participates in training sessions to enhance understanding of clinical research processes.
• May co-monitor at local site visits for experiential learning of how clinical research sites operate and are overseen by the sponsor and/or CRO.
• Provide general administrative support to the Clinical Operations team, including scheduling meetings, coordinating travel arrangements, and managing documents.
• Processes and facilitates invoices, financial payments, preparation of Drug Shipment forms and milestone tracking for ISS studies.
• Interacts with the RRD Regulatory Team as it relates to annual Product Safety Update Reports and Drug Safety Update Reports for marketed products and products in the development lifecycle. Collaborates with other departments within RRD such as Finance, QA, Compliance, and other cross-functional departments involved in the execution of clinical trials or ISS.
• Act in full compliance with all laws, regulations, and policies including adverse events and pharmacovigilance responsibilities.

Education and Experience

• Bachelor's degree, preferably in the life/physical sciences, required.
• Minimum 1 year of relevant experience working in a regulated environment related to Clinical Development activities, such as Pharmaceutical, Medical Device, Biotech or Biopharmaceutical companies. Must have experience working on Phase 1-4 clinical development studies.
• Experience working with Investigator Initiated Studies, or within rare diseases, desirable but not required.

Knowledge, Skills, and Professional Attributes

• Fluent in English (oral and written communication).
• Excellent computer skills, with strong proficiency in Veeva Vaults, Microsoft Office, and other systems related to the execution of clinical studies.
• Organized, adaptable, excellent time management, and shows initiative.
• Knowledge and awareness of Good Clinical Practice, 21CFR, parts 312 and 56, ICH Guidelines, and Data Privacy guidelines.
• Quality mindset related to execution of clinical studies and ALCOA+ principles.

Location/Travel

The location for this position is the Bridgewater, New Jersey office. Candidate is generally required to be on-site Tuesday through Thursday each week, with Mondays and Fridays working remotely. The position may require domestic travel (approximately 0-5%). Based upon job requirements, employee may be required at times to attend meetings including travel out of state over weekends and nights. Employee must be able to freely operate and travel by car and train/plane modes of transportation. Employee is required to have a valid driver's license and means of transportation.