Clinical Research Coord II - Bowie, MD

Summarized Purpose: Study coordinator to support an ongoing large clinical study in the US. The coordinator completes all required paperwork to capture data as specified by the study protocol and ensures subject safety, understanding, and cooperation throughout the study process. They interact with the research site team and other interdepartmental staff, engaging in recruitment, enrollment, retention of study participants, data entry, and query resolution. Essential Functions Conduct clinical studies according to FDA/GCP and ICH regulations and guidelines. Provide medical care to patients, always ensuring patient safety comes first. Schedule subject visits within protocol windows, ensuring scheduling capacity is maximized. Perform all defined study activities (e.g., informed consent, screening, and protocol procedures including but not limited to vital signs, pregnancy tests, height, weight, ECG, etc.). Record all patient information and results from tests as per protocol on required forms. Where required, complete IP accountability logs and associated information. Report suspected non‑compliance to relevant site staff. Ensure that IRB approval is obtained before study initiation and that 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 all other relevant meetings to receive protocol training. Call patients, make bookings, and follow‑up calls to confirm bookings or provide information or results as required. Log/complete information on sponsor systems, ensuring data is accurate and completed within the required timeframe. Gather and maintain source documents, update patient files and notes, ensuring data is up to date. Adhere to company COP/SCOP. Dispose of waste according to standards and assist in keeping the facility neat. Education and Experience Bachelor’s degree or equivalent in a clinical or medical field. Must hold a valid nursing license (RN, LVN, LPN) in the operating country, registered with the local health care authority. Previous experience equivalent to at least 2 years in a related role. Knowledge, Skills and Abilities Solid understanding of the clinical research process (GCP, SOPs, informed consent, safety monitoring, etc.). Capable of working independently, analyzing, prioritizing sensitive complex information, and solving problems. Demonstrated ability to exercise discretion and sound judgment. Good decision‑making, negotiation, and influencing skills. Good communication skills and English fluency will be an advantage. Good organizational skills. Proficiency in basic computer applications. Interpersonal skills to work in a team environment. Pay Rate Range: $20 – $29.08 #J-18808-Ljbffr Planet Pharma