Clinical Research Coordinator II

About the Role

A study coordinator supporting an ongoing large clinical study in the US. Responsibilities include completing all required paperwork to capture study data, ensuring subject safety, understanding, and cooperation, and interacting with the research site team and other interdepartmental staff. The role encompasses the entire site operations process, including recruitment, enrollment, retention of study participants, data entry, and query resolution.

Responsibilities

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, prioritizing patient safety.
• Schedules subject visits within protocol windows, maximizing scheduling capacity.
• Performs study activities such as informed consent, screening, and protocol procedures (e.g., vital signs, pregnancy tests, height, weight, ECGs).
• Records all patient information and test results as per protocol on required forms.
• Completes investigational product (IP) accountability logs where required.
• Reports suspected non-compliance to relevant site staff.
• Ensures IRB approval is obtained prior to study initiation and meets IRB requirements throughout the study.
• Promotes the company and builds positive relationships with patients to ensure retention.
• Attends site initiation meetings and other relevant meetings for protocol training.
• May call patients, manage bookings, and conduct follow-up calls to confirm appointments or provide information.
• Logs and completes information on sponsor systems (e.g., case report forms, EDC) accurately and within timeframes.
• Gathers and maintains source documents, updates patient files, and ensures up-to-date information is recorded.
• Adheres to company COP/SCOP.
• May dispose of waste according to standards and assist in maintaining facility neatness.

Requirements

• Bachelor’s degree or equivalent and relevant formal academic/vocational qualification in the clinical/medical field.
• Valid nursing license (RN, LVN, LPN) within the operating country.
• Registered with the local healthcare authority.
• Previous experience (comparable to 2+ years) in a relevant role.

Skills

• Solid understanding of the clinical research process (e.g., GCP, SOPs, informed consent, safety monitoring).
• Ability to work independently, analyze details, and prioritize sensitive, complex information.
• Strong problem-solving, decision-making, negotiation, and influencing skills.
• Good communication skills; English fluency is an advantage.
• Strong organizational and interpersonal skills for teamwork.
• Proficiency in basic computer applications.

Pay

Pay rate range: $20 - $29.08 per hour.