Entry Level Document Control / Project Support Coordinator | Clinical Research

Overview
Join our dynamic clinical research team as an Assistant Project Coordinator specializing in Source Documents Building! In this vital role, you will support the management of clinical trial documentation, ensuring accuracy, compliance, and seamless data flow. Your proactive approach will help accelerate research progress, uphold regulatory standards, and contribute to groundbreaking medical advancements. This paid position offers an exciting opportunity to develop your skills in clinical trials management while making a meaningful impact on patient care and scientific discovery.

Duties

• Assist in the collection, review, and organization of source documents for clinical trials, ensuring completeness and adherence to protocol specifications.
• Support the creation and maintenance of source document builder templates aligned with GCP-ICH standards and regulatory requirements.
• Review clinical trial documentation for consistency, accuracy, and regulatory compliance before submission or archiving.
• Contribute to data management efforts by organizing source documents for efficient retrieval and audit readiness.

Qualifications

• Demonstrated ability to coordinate multiple tasks within a clinical research environment.
• Able to communicate fluently in English and Spanish
• Knowledge of basic clinical trials management, including familiarity with FDA regulations, ICH GCP standards, and CDISC data standards.
• Strong understanding of medical terminology, clinical laboratory procedures, blood sampling techniques, and patient monitoring protocols.
• Experience reviewing documentation for accuracy, completeness, and compliance with regulatory standards such as HIPAA and GCP.
• Proficiency in statistical software tools used for data analysis within clinical research settings.
• Background in clinical development or nursing with hands-on experience in clinical trials or laboratory environments preferred.
• Excellent organizational skills with attention to detail; ability to adhere strictly to compliance management protocols. Embark on a rewarding journey where your expertise fuels innovative healthcare solutions! We are committed to fostering an inclusive environment that supports your professional growth while contributing to life-changing medical research.

Pay: $18.00 - $21.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person