Responsibilities
Performs necessary functions as approved by the Investigator and after the completion of required training, for the conduct of clinical research; Adheres to GCP, ICH, HIPAA, FDA Regulations and SOPs. Participant enrollment: Assists the CRC and/or Manager with study recruitment; Assists the CRC with patient enrollment and tracking; Assists with the basic screening of patients for study enrollment; Schedules subjects for study visits and conducts appointment reminders; Assists with patient follow-up visits; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines. Participant chart maintenance: Responsible for scanning, filing, and completing tasks within Clinical Trial Management Software (CTMS) and electronic Investigator Site File (e-ISF). Documents in source clinic charts; Assists the CRC with updating and maintaining logs and filing in e-charts. Completes data entry into case forms ensuring accuracy of data and ing of adverse events to sponsor; Ensures study related s and patient results are reviewed by the Clinical Research Coordinator and/or Investigator in a timely manner; Organizes work area. Perform basic lab procedures, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; and Accurately processes and sends lab specimens per protocol specifications; Utilizes universal precautions when in contact with possible contaminants, obtains and maintains certification for the handling of potential infectious fluids and maintains safety for self, patient and others around them. May obtain vital signs and ECGs, then provide those to the Investigator for review. Site organization and upkeep. Manage study supplies, inventory, prepping, and ordering. May perform other duties not specifically listed in this job description as assigned by their immediate supervisor.
Requirements
High School Diploma/GED Equivalency
Work Schedule: 8-hours, Days, Monday through Friday
Physical Requirements and working conditions for this position will be provided to you upon interview.
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