We are seeking a detail-oriented Clinical Trials Management Associate I (CTMA I) to support the execution and oversight of clinical trials. This role involves providing administrative assistance in site selection, study coordination, and regulatory compliance while ensuring adherence to protocols, Good Clinical Practice (GCP), and regulatory requirements. The CTMA I will work closely with study sites, Contract Research Organizations (CROs), and internal teams to facilitate the successful execution of clinical studies.

Key Responsibilities:

• Fulfill all requirements of the Clinical Project Assistant role with demonstrated proficiency.
• Provide administrative support in site selection, study implementation, and ongoing coordination of study sites, either directly or through CROs.
• Monitor study sites, ensuring accurate data collection, source data verification, and regulatory document review in compliance with protocols, regulatory requirements, SOPs, and the Monitoring Plan.
• Assist in the review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts, and clinical study reports under supervision.
• Contribute to the compilation of investigator brochures with guidance.
• Identify and resolve routine monitoring issues as needed.
• Support the preparation of safety, interim, and final study reports, including resolving data discrepancies.
• Travel as required for site visits and study oversight.

Qualifications & Skills:

• Strong verbal, written, interpersonal, and presentation skills.
• Familiarity with medical and scientific terminology.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Knowledge of FDA and/or EMEA regulations, ICH guidelines, and GCPs governing clinical trials (preferred).
• Ability to participate in departmental or interdepartmental strategic initiatives with general supervision.
• Contribution to Standard Operating Procedure (SOP) development.

This role is ideal for individuals looking to build a career in clinical trials management while working in a collaborative and regulated research environment.