Clinical Research Study Coordinator

Clinical Research Study Coordinator

About This Job

Join our dedicated team as a Clinical Research Study Coordinator, where you play a pivotal role in advancing medical science. This position manages the daily operations of clinical trials, ensuring participant safety and data integrity. You directly contribute to groundbreaking research, transforming patient care and bringing new treatments to light. Your expertise and meticulous work are essential to the success of our studies and the well-being of our participants.

Job Duties and Responsibilities

As a Clinical Research Study Coordinator, you drive the successful execution of clinical trials by:

• Manages all aspects of study coordination, overseeing trial progress from start-up to close-out.
• Ensures strict protocol adherence for all research activities, maintaining study integrity.
• Obtains and documents informed consent from study participants, explaining trial details clearly and ethically.
• Protects patient privacy by upholding rigorous HIPAA compliance standards.
• Applies ICH-GCP guidelines consistently across all trial procedures and documentation.
• Executes all tasks with exceptional attention to detail, ensuring accuracy in data and records.
• Identifies, documents, and reports adverse events promptly and accurately to ensure participant safety.
• Utilizes medical terminology effectively in all communications and documentation related to the study.
• Performs precise data collection, entering information into electronic systems or case report forms.
• Maintains comprehensive and accurate source documentation, ensuring all study records are complete and verifiable.
• Schedules participant visits, manages study calendars, and coordinates with internal and external stakeholders.
• Communicates effectively with participants, investigators, sponsors, and institutional review boards (IRBs).

Required Qualifications

Education

• Holds a Bachelor's degree in a health-related field, life sciences, or a relevant discipline.

Experience

• Possesses at least two years of experience in clinical research or a related healthcare setting.
• Demonstrates proven experience in study coordination and trial management.

Knowledge/Skills

• Applies a strong understanding of ICH-GCP principles and regulatory requirements.
• Exhibits proficiency in ensuring protocol adherence throughout clinical trials.
• Masters the process of obtaining and documenting informed consent.
• Maintains expert knowledge of HIPAA compliance and patient privacy regulations.
• Demonstrates exceptional attention to detail in all tasks and documentation.
• Performs accurate adverse event reporting and follow-up.
• Understands and applies medical terminology effectively.
• Excels in data collection and data entry accuracy.
• Manages comprehensive and verifiable source documentation.
• Communicates clearly and effectively, both verbally and in writing.
• Organizes work efficiently and manages multiple priorities in a fast-paced environment.

Preferred Qualifications

• Obtains certification as a Clinical Research Coordinator (e.g., CCRP, CCRC).
• Possesses experience in a specific therapeutic area relevant to our current research.

Physical Requirements/Work Conditions

• Works primarily in an office or clinical research environment.
• Sits for extended periods while performing computer-based tasks.
• Utilizes standard office equipment such as computers, phones, and photocopiers.
• May require occasional travel to other research sites or conferences.