Clinical Research Coord II - Bowie, MD

About the role

The study coordinator will support an ongoing large clinical study in the US, completing all required paperwork to capture data as specified by the study protocol, and ensuring subject safety, understanding, and cooperation during the study process.

The coordinator will interact with the research site team and other interdepartmental staff, and engage in the entire site operations process, including recruitment, enrollment, retention of study participants, data entry, and query resolution.

Responsibilities

• Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines
• Provide medical care to patients, ensuring patient safety comes first
• Schedule subject visits within protocol windows, maximizing scheduling capacity
• Perform defined study activities, such as informed consent, screening, and protocol procedures
• Record patient information and results from tests as per protocol on required forms
• Report suspected non-compliance to relevant site staff
• Ensure IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study
• Promote the company and build a positive relationship with patients to ensure retention
• Attend site initiation meetings and other relevant meetings to receive training on protocol
• Log and complete information on sponsor systems, ensuring accuracy and timely completion
• Gather and maintain source documents, updating patient files and notes with relevant and up-to-date information
• Adhere to company COP/SCOP and dispose of waste according to standards

Requirements

• Bachelor's degree or equivalent in the clinical/medical field
• Valid nursing license (RN, LVN, LPN) within the country operating
• Registration with local health care authority
• Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 2+ years)

Skills

• Solid understanding of the clinical research process (GCP, SOPs, informed consent, safety monitoring, etc.)
• Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information, and problem-solve
• Demonstrated ability to exercise discretion and sound judgment
• Good decision-making, negotiation, and influencing skills
• Good communication skills and English fluency
• Good organizational skills
• Good proficiency in basic computer applications
• Good interpersonal skills to work in a team environment

Pay

The pay rate range for this position is $20 - $29.08 per hour.