What are the responsibilities and job description for the Research Coordinator (Prescreen) position at Actalent?
Description:
This position will be responsible for Quality Control (QC) GCP activities. The primary responsibilities will be to ensure quality and compliance of Clinics clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country specific, and current industry standards and practices) as well as support the non-clinical team on ensuring Covenant Research and Clinics studies are conducted in a compliant manner. This position reports to the Chief Financial Officer/Chief Strategy & Growth Officer.
• Perform routine and non-routine quality control reviews to include but not limited to: in screening; prior to randomization subjects; post randomization subjects; screen fail subjects; completed trial subjects
• Ensure the timely and effective follow up of all identified or assigned quality issues
• Lead in preparing investigational sites for Sponsor and regulatory inspections
• Conduct 100% QC review of all ICFs, Protocol Deviations, SAE’s and other clinical trial specified documents
• Conducts 100% Source Data Verification of all Clinic Visits with the corresponding electronic Case Report Forms (eCRFs) for each trial
• Reports trends from QC findings to assure compliance and contiguous improvement
• Schedules and/or delivers monthly QC educational sessions
• Detailed Quality Control Associate Protocol and QC Workflows attached
Skills:
Clinical trial
Top Skills Details:
Clinical trial
Additional Skills & Qualifications:
Must have strong chart review exp
This person has to have good attention to detail.
They will be checking over all electronic charts to make sure the patient qualifies to randomize, qualifies for the biopsy
Experience Level:
Intermediate Level
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Salary : $33
