Per Diem Clin Research Coordinator II - Onsite Lafayette, 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 all required 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, managing daily tasks, visit calendar development and maintenance, scheduling and attending monitor visits, 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, monitor study updates, and submit data in required timeframe
• Facilitate audits of study data, develop patient rapport, and respond to inquiries by auditors for data clarification or additional data in required timeframe
• Take the lead and/or overall coordination of clinic activities including supervision of clinic visits, screening eligibility, overseeing study drug administration, and coordinating and monitoring screening activities
• Monitor appropriate sources for specific clinical study or federal regulation updates, collect and enter study data into the appropriate system, and coordinate and monitor screening activities
• Develop rapport with study team to educate team on study procedures and minimize protocol violations, and address day-to-day subject or study issues and escalate as appropriate
• Coordinate and perform regulatory activities including maintaining proper protocol, consent, amendment, and yearly renewal submissions if requested, reporting adverse events, and maintaining 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