Clinical Trial Associate

Recordati; Bridgewater Township (NJ); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Recordati Rare Diseases, Inc. (RRD) in North America seeks a Clinical Trial Associate to support clinical studies (Phase I–IV, PAES, Registries) and daily operations within Clinical Operations. You will work with external vendors and trial sites to ensure efficient trial execution and documentation.

The role emphasizes CTMS/TMF record-keeping, regulatory compliance, and cross-functional collaboration to support sponsor and CRO activities.

Qualifications

• Bachelor's degree required in life/physical sciences or related field.
• Minimum 1 year of regulated environment experience in Clinical Development (Phase 1–4).
• Experience with Investigator Initiated Studies or rare diseases desirable but not required.

Responsibilities

• Maintain organized records for clinical trials and data in CTMS/TMF/SharePoint.
• Ensure documentation complies with regulatory guidelines and SOPs.
• Coordinate protocol amendments and communicate changes to teams.
• Coordinate site initiation, monitoring, and close-out visits in CTMS/TMF.
• Keep up-to-date with clinical research regulations and participate in trainings.
• Provide general administrative support to the Clinical Operations team.
• Process invoices and drug shipment forms for ISS studies.
• Collaborate with Regulatory, Finance, QA, and other departments.

Skills

Fluent English

Excellent computer skills

Education

Bachelor's degree in life/physical sciences

Tools

Veeva CTMS

Trial Master File (TMF)

Job description

At Recordati, we are united by a clear purpose: unlocking the full potential of life. With a century of history behind us, we are building the next chapter of our journey, continuing to grow while keeping patients at the centre of all we do.

What drives us is a shared belief that health, and the opportunity to live life to the full, should be within reach for everyone. This brings energy to our work, shaping how we support each other and show up every day. Our values - Better Together, Never Settle and Always Deliver - reflect this mindset, helping us to keep improving and make a meaningful difference.

Above all, these values bring to life our promise to everyone at Recordati, you can unlock your full potential. We know that people thrive when they can be themselves, are trusted and supported, and are given the opportunity to grow and make a meaningful contribution.

Are you ready to unlock your full potential?

This position is with Recordati Rare Diseases, Inc. (RRD), North America, an affiliate of Recordati.

Recordati Rare Diseases, Inc. (RRD) develops high-impact therapies for devastating rare diseases, focusing on providing often overlooked treatments to underserved communities in the U.S. Our mission is to mitigate the impact of rare diseases through increased awareness, improved diagnoses, and enhanced treatment availability, covering endocrinology, metabolic, and oncology franchises. RRD is dedicated to excellence, fostering a dynamic work environment that promotes professional growth and a significant impact on patients' lives.

Reporting Structure

Reports To: Director, Clinical Operations
Direct Reports: N/A
Areas Managed: Day-to-day operational aspects and tracking of Clinical Operations and ClinicalTrial Supply activities

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 relevantdocumentation 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, andstudy plans (monitoring, data review, etc.).
• Helps coordinate protocol amendments and updates, ensuring all team members are informed ofchanges, arranging meetings to discuss amendments, supporting the CTMs with documentation andfollow-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 trainingsessions to enhance understanding of clinical research processes.
• May co-monitor at local site visits for experiential learning of how clinical research sites operate andare 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 andmilestone tracking for ISS studies.
• Interacts with the RRD Regulatory Team as it relates to annual Product Safety Update Reports and DrugSafety Update Reports for marketed products and products in the development lifecycle. Collaborateswith other departments within RRD such as Finance, QA, Compliance, and other cross-functionaldepartments involved in the execution of clinical trials or ISS.
• Act in full compliance with all laws, regulations, and policies including adverse events andpharmacovigilance 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 ClinicalDevelopment activities, such as Pharmaceutical, Medical Device, Biotech or Biopharmaceuticalcompanies. 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