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 2-3 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.
Seniority level
Entry level
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Staffing and Recruiting
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