Clinical Research Coordinator II

Summarized Purpose: 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. Essential Functions: 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 Pay Rate Range: $20 – $29.08 #J-18808-Ljbffr Planet Pharma