Clin Research Coordinator Ii- Barcelona (Spain)

.Clin Research Coordinator II- Barcelona (Spain) DescriptionJOB SUMMARYCoordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulations.Frequency of onsite support: 2days a weekJOB RESPONSIBILITIESClinical Research Project Planning and Preparation- Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources.- Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study.- Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings).- Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following:O Clinic logistics planning, schedule of clinic activities, and team training.O Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules.O In collaboration with the responsible teams, establishes and/or maintains 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.O Confirms all required regulatory and contractual documentation is present prior to study start.- Support the Principal Investigator as needed with study related tasks such as, but not limited to:O Delegation of Authority Log.O Management of daily tasks.O Visit calendar development and maintenance.O Scheduling and attending monitor visits.Advertise, recruit, and screen potential participants for the study.Clinical ConductPerform all study activities following Good Clinical Practices (GCP).Manage multiple clinical trials simultaneously.Protect the safety of human subjects.Monitor appropriate sources for specific clinical study or federal regulation updates.Collect and enter study data into the appropriate system.- Coordinate and monitor screening activities; provides support as required.- Assist with informed consent of study subjects.Submit data in required timeframe.Monitor appropriate sources for specific clinical study or federal regulation updates.Complete Case Report Forms.Facilitate audits of study data.Develop patient rapport to explain research protocols and minimize protocol violations.Develop rapport with study team to educate team on study procedures and minimize protocol violations.- 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, but not limited to:O Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable