CLINICAL RESEARCH COORD II – BOWIE, MD

Essential Functions

• Conducts clinical studies according to FDA/GCP and ICH regulations and guidelines.
• Provides medical care to patients, ensuring patient safety comes first.
• Schedules subject visits within protocol windows, maximizing scheduling capacity.
• Performs all defined study activities, including informed consent, screening, and protocol procedures such as 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, completes IP accountability logs and associated information.
• 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 a positive relationship with patients to ensure retention.
• Attends site initiation meetings and other relevant meetings to receive training on protocol.
• Makes phone calls to patients, schedules bookings, and follows up to confirm bookings or provide information/results.
• Logs/completes information on sponsor systems and ensures accuracy (e.g., case report forms, EDC, etc.), completing within the required timeframe.
• Gathers and maintains source documents, updates patient files and notes, ensuring relevant and up-to-date information is recorded.
• Adheres to company COP/SCOP.
• May be required to dispose of waste according to standards and assist in maintaining a 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 comparable to 2+ years’.

Knowledge, Skills And Abilities

• Solid understanding of the clinical research process (e.g., 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 judgment.
• Good decision-making, negotiation, and influencing skills.
• Good communication skills and English fluency (an advantage).
• Good organizational skills.
• Good proficiency in basic computer applications.
• Good interpersonal skills to work in a team environment.