CRC II; Onsite - Euless, TX

Overview

Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives.

Locations & Job IDs

• Morrisville, NC, United States (Job : )
• Euless, TX (CRC II Onsite) – additional posting

• Clinical Research Project Planning and Preparation: review 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 related meetings). Take the lead and/or overall coordination of start-up activities, including clinic logistics, schedule of clinic activities, and team training.
• Prepare, review and finalize clinic source documents, time and events tables, and other required study materials; review CRFs, laboratory workbooks, staff requirements, and schedules.
• Collaborate with responsible teams to establish/maintain safety assessment requirements, QC and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other applicable elements;
• Ensure all regulatory and contractual documentation is present prior to study start. Support the Principal Investigator with study tasks (e.g., Delegation of Authority Log, daily task management, visit calendar development, monitor visits).
• Advertise, recruit, and screen potential participants for the study.
• Clinical Conduct: perform all study activities following Good Clinical Practices (GCP); manage multiple trials; protect the safety of human subjects; collect and enter study data; monitor screening activities and assist with informed consent; complete Case Report Forms; facilitate audits; develop patient rapport and educate the team on procedures to minimize protocol violations.
• Coordinate clinic activities (supervise visits, oversee drug administration as delegated, ensure activities are conducted per protocol, SOPs and regulations).
• Manage and review clinic updates, AE/SAE reporting, study logs, QC, and monitor findings; coordinate post-clinic/close-out activities and TMF updates; finalize study and volunteer logs.
• Travel up to 100% as required; accommodate flexible schedules (days, afternoons, nights, weekends).
• Regulatory
  
  Activities:
  
  maintain protocol, consent, amendments, and renewals; report adverse events; maintain study files.

• Registered Nurse and/or University Degree (Bachelor of Science) required;
  Clinical Research certification preferred.
• Minimum 1 year experience in clinical research required (2+ years preferred), preferably coordinating clinical research projects.
• Knowledge of regulations, ICH GCP, privacy, and applicable guidelines; strong problem solving, planning, evaluation, and time management skills; ability to multi-task and work in a team.
• Proficiency with MS Office (Word, Excel, PowerPoint); experience with EDC software preferred; prior on-site patient visit experience preferred.
• Excellent interpersonal and communication skills; ability to anticipate problems and provide timely solutions; SOP writing knowledge; ability to coordinate multiple projects with deadlines.

• Benefits may include health benefits (medical, dental, vision), company 401k match, stock purchase plan eligibility, commissions/bonus eligibility, and flexible PTO/sick time. Paid sick time eligibility varies by location;
  Syneos complies with applicable laws.
• Salary Range: $67,700.00 – $. The base salary range represents the anticipated range; actual salary varies by qualifications, skills, and role proficiency.

Tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks at its discretion. Equivalent experience, skills, and/or education will be considered. The company complies with applicable laws and is committed to an inclusive workplace. Reasonable accommodations may be provided under the Americans with Disabilities Act where appropriate.