Clinical Research Coordinator II

Job Description

Job Summary:

• Study coordinator to support ongoing large clinical study in US.
• Completes all paperwork required to capture all data as specified by a study protocol, and for ensuring subject safety, understanding, and cooperation during the study process.
• Interacts with the research site team and other interdepartmental staff.
• Engages in the entire site operations process, which includes recruitment, enrollment, retention of study participants, data entry and query resolution.

Duties and Responsibilities:

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, always ensuring patient safety comes first.
• Schedules subject visits within protocol windows, ensuring scheduling capacity is maximized.
• Performs all defined study activities (i.e., informed consent, screening, and protocol procedures which include but not limited to vital signs, pregnancy tests, height, weight, ECG’s, etc.).
• Records all patient information and results from tests as per protocol on required forms.
• Where required, may complete IP accountability logs and associated information.
• Reports suspected non-compliance to relevant site staff.
• Ensures that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
• Promotes the company and builds a positive relationship with patients to ensure retention.
• Attends site initiation meetings and all other relevant meetings to receive training on protocol.
• May be required to call patients, do patient bookings and follow-up calls to confirm bookings or provide information or results.
• Logs/completes information on sponsor systems and ensures all information provided is accurate (i.e., case report forms, EDC, etc.) and ensures it is completed within timeframe.
• Gathers and maintains source documents, updates patient files and notes, always ensuring relevant and most up to date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in keeping a general neat appearance of the facility.

Education and Experience:

• Bachelor’s degree or equivalent and relevant formal academic / vocational qualification in the clinical / medical field.
• Must hold a valid nursing license (RN, LVN, LPN) within the country operating.
• Must be registered with local health care authority.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’).

Knowledge, Skills and Abilities:

• Solid understanding of the clinical research process (i.e., GCP, SOPs, informed consent, safety monitoring, etc.).
• Capable of working independently, analyzing and working with attention to detail, processing and prioritizing sensitive complex information and problem solving.
• Demonstrated ability to exercise discretion and sound judgement.
• Good decision-making, negotiation and influencing skills.
• Good communication skills and English fluency will be an advantage.
• Good organizational skills.
• Good proficiency in basic computer applications.
• Good interpersonal skills to work in a team environment.