Clinical Research Coordinator

Core Responsibilities

• Manage essential regulatory documents, including Institutional Review Board (IRB) submissions and safety reports, ensuring compliance with all regulatory authorities and guidelines.
• Complete and maintain accurate source documentation and data entry.
• Address queries and action items promptly to ensure the integrity and timeliness of trial data.
• Perform E-source data entry and maintain real-time data accuracy, as applicable.
• Submit necessary documents to regulatory authorities and/or review/monitoring boards, including DSMB and independent safety officers, in a timely and compliant manner.
• Facilitate pre-study, site qualification, study initiation, and monitoring visits, as well as study close-out activities.
• Career coordination and communication, ensuring effective communication and collaboration among team members.
• Collect, process, and ship laboratory specimens following study protocols and regulatory requirements.
• Schedule subject visits and procedures, ensuring participants' compliance with the study schedule.
• Conduct recruitment, pre-screening, screening, baseline enrollment, and follow-up visits, maintaining a participant-centered approach.
• Manage inventory and maintain accountability logs for investigational products, devices, and study-related supplies.
• Retain records and archive documents after study close out, following regulatory guidelines and best practices.
• Requires Phlebotomy certification, indicating the ability to perform blood draws and other specimen collection as part of the study procedures.

Required Skills And Abilities

• Effective Writing and Communication: Capable of clear and concise documentation, and excellent interpersonal communication skills for interactions with study participants, team members, and regulatory bodies.
• Teamwork: Ability to work collaboratively within a research team, contributing positively to team dynamics and supporting team members.
• Multitasking: Proficiency in managing multiple tasks and priorities efficiently, adapting to changing demands with attention to detail and accuracy.
• Regulatory Knowledge: In-depth understanding of clinical trial regulations, ethical guidelines, and compliance standards, with the ability to apply these in practical settings.
• Organizational Skills: Strong organizational and project management skills to oversee study activities, manage documentation, and ensure compliance with study protocols.

Preferred Qualifications

• Educational Background: Bachelor's Degree in life sciences, nursing, public health, or a related field, or Master's Degree in a relevant field (such as clinical research, biostatistics, epidemiology, or healthcare management).
• Professional Experience: 1-2 years of relevant experience in clinical research or a closely related field for Bachelor's Degree holders, or no practical experience necessary for Master's Degree holders, but internships, training, or exposure to clinical research during academic studies will be advantageous.
• Skills: Regulatory Knowledge, Data Management Skills, Communication Skills, Organizational and Multitasking Abilities, Attention to Detail, Problem-Solving Skills, Adaptability, Teamwork.
• Personal Attributes: Experience with Specific Populations or Therapeutic Areas, Technology Proficiency.