We are looking for a strong Clinical Research Coordinator with at least 2 years experience preferred and early phase and late phase experience is highly desirable. The ideal candidate will have polished communication and organizational skills, comfortable with a teamwork approach, have project management experience, and knowledge of clinical research is strongly desired. The Clinical Research Coordinator will have first line contact with our study participants and sponsor’s, as well as staff working the study. Well-developed communication skills are necessary for the positon. Advanced leadership skills, gained through experience, are essential to be successful. Applicants must have a strong work ethic. The candidate should be well versed with Microsoft Office and comfortable learning new computer applications.
The clinical research coordinator is responsible for all aspects of conducting clinical trials. He/she is responsible for ensuring strict protocol adherence. Responsible for ensuring that Food and Drug Administration regulations are met, as well as study budgets and time lines. Position performs duties associated with the coordination and implementation of research study/projects, participant recruitment, data collection, and the management of study-generated data.
PRIMARY DUTIES AND RESPONSIBILITIES:
Responsible for all aspects of conducting clinical trials to ensure strict protocol and Food and Drug Administration (FDA) guidelines are met as well as study budgets and timelines
Responsible for coordinating and conducting procedures to ensure study participants meet inclusion and exclusion criteria
Develop and maintain schedules for participant visits
Ensure all procedures and techniques used follow internal standard operating procedures (SOPs) and external regulations and guidelines for participant safety
Attendance at sponsor training sessions
Training study staff prior to start of clinical conduct
Source document creation and management
Dose study participants with study drug(s) per protocol and randomization
Ensure participant safety is priority through observation and collection of adverse events
Organize and author clinical summaries
Author informed consent forms (ICFs) per the Code of Federal Regulations (CFR) guidelines
Discuss and explain pertinent aspects of the ICF with potential participants
Report progress of studies to sponsors
Assist with protocol procedures in clinic as required
Receipt of study drug(s), dispensation of study drug(s), and complete drug accountability, including final disposition of the study drug(s)
QPS Bio-Kinetic is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status
About QPS Bio-Kinetic
QPS is a clinical research organization supporting the discovery and clinical development of drugs. Headquartered in Newark, Delaware, QPS has laboratories in three states and five countries. The local laboratory is one of just over 1,000 clinical research organizations and is centrally located in Springfield, Missouri. Since opening its doors in 1994, QPS has conducted over 1000 FDA-regulated studies and paid out over $35 Million to local participants.