Remote - Clinical Trial Associate

A highly reputable pharmaceutical corporation is currently looking for a dedicated and qualified Remote - Clinical Trial Associate - Level I to work remotely in the United States with a strong preference for professional to live in eastern time zone.

Job Summary:

We are seeking a dedicated Clinical Trial Associate with a focus on rare diseases to join our team. The incumbent will play a pivotal role in the planning, coordination, and execution of clinical trials related to rare diseases.

The ideal candidate will possess a strong understanding of regulatory requirements, exceptional organizational skills, and the ability to collaborate effectively with cross-functional teams.

This role offers an exciting opportunity to contribute to the advancement of therapies for individuals affected by rare diseases.

Responsibilities:

• Support the development and implementation of clinical trial protocols specific to rare diseases, ensuring compliance with regulatory standards and guidelines.
• Coordinate trial activities in collaboration with clinical investigators, study sites, and vendors to facilitate efficient trial execution.
• Assist in the preparation and submission of regulatory documents, including but not limited to, Investigational New Drug (IND) applications, Institutional Review Board (IRB) submissions, and Clinical Trial Applications (CTAs).
• Collaborate with internal teams to ensure accurate and timely data collection, monitoring, and reporting throughout the trial lifecycle.
• Facilitate site initiation, training, and ongoing support to ensure adherence to protocol requirements and regulatory standards.
• Perform regular site visits to monitor trial progress, assess site compliance, and address any issues or concerns as they arise.
• Maintain trial-related documentation and files in accordance with regulatory requirements and company procedures.
• Contribute to the development and review of study-related documents, including informed consent forms, case report forms, and study manuals.
• Support the resolution of queries, discrepancies, and data issues in collaboration with study sites and data management teams.
• Assist in the preparation and coordination of investigator meetings, study team meetings, and other trial-related activities.
• Stay current with developments in the field of rare diseases and clinical trial management, applying relevant knowledge to enhance trial operations and outcomes.

Qualifications:

• Bachelor's Degree in life sciences, nursing, or a related field; advanced degree preferred.
• Minimum of 2+ years of experience in clinical trial management, with specific experience in rare diseases strongly preferred.
• Solid understanding of clinical trial processes, regulatory requirements, and Good Clinical Practice (GCP) guidelines.
• Excellent organizational, communication, and interpersonal skills with the ability to work effectively in a cross-functional team environment.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office Suite and familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
• Willingness to travel domestically and internationally, as needed, for site monitoring and trial-related activities.
• Certification in clinical research (e.g., ACRP or SOCRA) is a plus.
• This job description outlines the essential responsibilities and qualifications for the Clinical Trial Associate role with a focus on rare diseases. Candidates who possess the requisite skills and experience are encouraged to apply and contribute to our mission of advancing therapies for individuals affected by rare diseases.