Clinical Research Coordinator II - Miami, FL (Future Opportunities)

Syneos Health; Miami (FL); On-site; USD 55,000 - 85,000; Full time

Job summary

Illingworth Research Group in Miami seeks a Clinical Research Coordinator II to support multiple clinical trials, from site preparation to patient enrollment and data entry.

You will coordinate start-up activities, monitor patient safety, ensure regulatory compliance, and collaborate with investigators and sponsor teams to keep trials on track. The role requires strong organizational skills and the ability to manage schedules including evenings or weekends.

Qualifications

• Review protocols and documentation for accuracy and feasibility.
• Prepare and maintain TMF and site files.
• Coordinate regulatory and start-up activities.
• Support informed consent and data entry.

Responsibilities

• 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: Clinic logistics planning, schedule of clinic activities, and team training.

Job description

Description

Clinical Research Coordinator II - Miami, FL (Future Opportunities)

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.

Job Responsibilities

Job Description

Clinical 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:
• 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 required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules.
• 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.
• 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:
• Delegation of Authority Log.
• Management of daily tasks.
• Visit calendar development and maintenance.
• Scheduling and attending monitor visits.
• Advertise, recruit, and screen potential participants for the study.

Clinical Conduct

• Perform 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:
• Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable.
• Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required.
• In collaboration with the responsible teams, monitors that all study-related 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.

Post-Clinic/Close-Out Activities

• Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings.
• Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation.
• Review and update TMF documentation.
• Finalize study and/or volunteer logs.
• Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.).
• Responsible for monitoring subjects’ compliance throughout the trial and address day-to-day. subject or study issues and elevate as appropriate.
• Prepare for and participates in sponsor/monitor/QA audits.
• Provide accurate and timely project status updates to Project Managers and sponsor.
• Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals.
• Accommodate flexible schedule (available days, afternoons, nights, and weekends).
• Perform other work-related duties as assigned.

Coordinate and Perform Regulatory Activities

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