Clinical Trials Associate

Summary

Join our research team as a detail-oriented and proactive Clinical Trials Associate! This crucial role ensures our clinical trials meet all clinical and GCP standards. You will manage multiple sites and studies, handle regulatory updates, prepare documentation, create electronic source documents, and maintain communication with sponsors and sites. The position involves supporting clinical trial planning, coordination, and execution, ensuring protocol adherence, and providing training to research staff. You will play a key role in regulatory submissions, quality control, and risk mitigation. This position requires strong organizational skills and experience in clinical research.

Requirements

• Bachelor’s degree in a health-related field, life sciences, or a related discipline, or equivalent 4 years of work experience
• 3+ years of formal work experience in clinical research, including 2+ years of experience in regulatory, specifically in clinical trials
• 3+ years of experience with Good Clinical Practice (GCP), FDA, and ICH guidelines
• 3+ years of experience working with electronic document management systems

Responsibilities

• Assist in the preparation, submission, and management of regulatory documents, including IRB submissions and amendments
• Ensure that all records are organized, audit-ready, and available for inspection
• Coordinate and manage study start-up activities, including site selection, initiation visits, and training sessions
• Create electronic source documents
• Assist in the management of electronic regulatory binder
• Support monitoring visits by preparing necessary documents and facilitating communication between study sites and monitors
• Ensure adherence to study protocols, Good Clinical Practice (GCP) guidelines, and regulatory requirements
• Maintain and organize study files, including regulatory binders, source documents, and case report forms (CRFs)
• Enter data into electronic data capture (EDC) systems and ensure timely query resolution
• Conduct routine quality control checks on study data and documents to ensure adherence to ALCOA-C
• Aid in the oversight of patient stipend processing
• Identify and mitigate potential risks associated with clinical trials
• Develop and implement Corrective and Preventive Actions (CAPA) as necessary
• Participate in training sessions and stay updated on industry standards, regulatory requirements, and best practices in clinical research
• Ensure that all aspects of clinical trials adhere to regulatory requirements
• Assist in the preparation and execution of study close-out activities, including final reports and archiving of study documents
• Ensure proper disposition of study supplies and investigational products
• Ensure adherence to study protocols and proactively address any site performance issues
• Contribute to the development and improvement of Standard Operating Procedures (SOPs) for compliance
• Participate in audits and review regulatory documents for accuracy and adherence to standards
• Assist the quality assurance department with ad hoc needs including but not limited to internal QA audits, IC reviews, I/E eligibility confirmation
• Serve as the main point of contact for the central and local IRBs
• Work closely with the CRCs, CTLs, site  managers, and site staff to ensure that regulatory submissions are completed within a timely manner
• Aid the facilities staff in ordering and procuring clinical supplies and equipment as necessary
• Other duties as assigned by manager

Preferred Qualifications

• Certification in clinical research (e.g., CCRC, CCRP) is a plus
• Located in Ann Arbor, Baltimore, DC, or Denver