Summary

Experienced clinical research coordinator to be an active team member in a research center specializing in infectious diseases treatments, prophylaxis, and epidemiologic research.

Job Duties

• Understands assigned research trials with complete familiarity of the protocol, manual of procedures, FDA regulations, Good Clinical Practice guidelines, standard operating procedures, and other established guidelines.
• Recruits, screens, enrolls, and evaluates study participants for focused research trials.
• Educates study participants to the objectives and requirements for IRB-approved research protocols.
• Coordinates clinic schedules including participant visit appointments, laboratory, and pharmacy involvement.
• Explains study processes and procedures to study participants including informed consent and eligibility requirements, which are of utmost importance.
• Tracks compliance of participants with study requirements and implements resolution measures when non-compliance is observed.
• Conducts all study visits according to protocol requirements.
• Collects, documents, and reconciles data according to protocol, manual of procedures, Sponsor, and federal requirements and guidelines.
• Assesses safety parameters by collecting adverse event and serious adverse event data, determines the significance of each event, and engages the physician investigator when necessary and appropriate.
• Is primary contact for assigned research trials for Sponsors, Sponsor agents, research team members, data coordinating center, federal agencies, and study participants. • Prepared to answer questions, organize personnel, coordinate schedules, and manage data queries related to the research trial.
• Maintains research records in a secure and confidential manner.
• Participates in quality management reviews and determines appropriate resolution of findings including initiating a corrective action plan when needed.
• Collects vital signs, blood and other biological samples according to established procedures.
• Enters data into study-specific database systems and conducts quality control reviews to ensure accuracy.
• Collaborates with regulatory, laboratory, pharmacy, and quality management personnel to ensure that processes and procedures are compliant with established guidelines and to rectify discrepancies, as needed.
• Facilitates monitoring visits by collaborating with Clinical Research Associates and by responding to queries when needed.
• Obtains and reviews clinical laboratory results and submits the results to a physician investigator. Repeats abnormal laboratory tests, as needed, until test results return to normal (or as required in the protocol).
• Inventories, orders, and stocks clinic supplies and equipment when needed.
• Calibrates clinic equipment as assigned.
• Administers study products according to protocol guidelines.
• Maintains a clean and safe work environment.
•  Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree in a related field. Four years of related experience may substitute for degree requirement.
• Two years of relevant experience.