Per Diem Clin Research Coordinator II - Onsite in West Monroe, Louisiana

Job Responsibilities

• Review and prepare assigned protocols and other protocol documentation (ICF, IB)
• Create and review timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings)
• Lead and coordinate start-up activities including clinic logistics planning, schedule of clinic activities, and team training
• Prepare and finalize clinic source documents, time and events tables, and other required study materials
• Collaborate with teams to establish and maintain safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study
• Confirm all required regulatory and contractual documentation is present prior to study start
• Support the Principal Investigator with study-related tasks such as delegation of authority log, visit calendar development and maintenance, scheduling and attending monitor visits, and advertising, recruiting, and screening potential participants
• Perform all study activities following Good Clinical Practices (GCP)
• Manage multiple clinical trials simultaneously, protect the safety of human subjects, and monitor appropriate sources for updates
• Collect and enter study data into the appropriate system, coordinate and monitor screening activities, and assist with informed consent
• Coordinate and monitor study drug administration, and other activities as delegated and required
• Monitor study-related activities according to protocol, SOP, and applicable regulations
• Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings
• Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings
• Finalize study and/or volunteer logs, ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.)
• Ensure subjects’ compliance throughout the trial and address day-to-day subject or study issues and escalate as appropriate
• Prepare for and participate in sponsor/monitor/QA audits
• Provide accurate and timely project status updates to Project Managers and sponsors
• Collaborate within and between teams during process improvement exercises, SOP creation, and other company-related initiatives and goals
• Accommodate flexible schedule (available days, afternoons, nights, and weekends)
• Perform other work-related duties as assigned

Regulatory Activities

• Maintain proper protocol, consent, amendment, and yearly renewal submissions if requested
• Report adverse events relating to the trial
• Maintain study files

Qualifications

• Registered Nurse and/or University Degree such as Bachelor of Science Degree required
• Clinical Research certification preferred
• A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred
• Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines
• Required skills: problem solving, planning, and evaluation
• Possess good time management, detail-oriented, and able to multi-task
• Good interpersonal and communication skills with a team focus
• Knowledge of SOP writing
• Ability to anticipate problems and provide solutions in a timely manner
• Ability to coordinate multiple clinical research projects with competing deadlines
• Proficiency in computer software programs (e.g. Word, Excel, Power Point)
• Proficiency in use of various clinical trial EDC software preferred