Clinical Research Coordinator - Per Diem - Fort Collins

Overview

Clinical Research Coordinator - Per Diem - Fort Collins (Onsite), CO. Illingworth Research Group provides patient-focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. We offer mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth operates in over 45 countries, bringing clinical research into the home of the patient to improve their experience and quality of life.

• Coordinate or co-lead assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs) and applicable regulations.
• Clinical Research Project Planning and Preparation
• Review assigned protocols and related documents (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).
• Lead and/or coordinate start-up activities including: clinic logistics planning, schedule of clinic activities, and team training; preparation, review and/or finalization of clinic source documents, time and events tables, and other study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules; establish and/or maintain safety assessment requirements, QC and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other study elements;
  
  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, management of daily tasks, visit calendar development/maintenance, and scheduling/attending monitor visits.
• Advertise, recruit, and screen potential participants for the study.

• Perform all study activities following Good Clinical Practices (GCP).
• Manage multiple clinical trials simultaneously and protect the safety of human subjects.
• Monitor sources for clinical study or federal regulation updates.
• Collect and enter study data into the appropriate system.
• Coordinate and monitor screening activities; provide support as required.
• Assist with informed consent of study subjects.
• Submit data in the required timeframe and complete Case Report Forms.
• Facilitate audits of study data and develop patient rapport to explain research protocols and minimize protocol violations.
• Develop rapport with the study team to educate on procedures and minimize protocol violations.
• Respond to inquiries by auditors for data clarification or additional data within required timeframe.
• Take lead and/or coordinate clinic activities including supervising clinic visits, screening eligibility prior to randomization, overseeing study drug administration, and ensuring activities are conducted 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 of QC, monitor, CRF, or other findings; oversee close-out of study documentation and return of study supplies as applicable.
• Review and update TMF documentation; finalize study and/or volunteer logs; ensure completion of required close-out activities.
• Monitor subjects’ compliance throughout the trial and address day-to-day issues, escalating as appropriate.
• Prepare for sponsor/monitor/QA audits; provide accurate and timely project status updates to Project Managers and sponsor.
• Collaborate within and between teams during process improvement, SOP creation or revision, and other company initiatives; accommodate flexible schedule (including days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.

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

Travel up to 100%

Hourly Rate: $50-$60

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