Research Coordinator

Essential Duties And Responsibilities

• Demonstrate understanding of the protocol elements and requirements.
• Responsible for clinical trial quality source document and adaptation of the protocol schedule events of assigned trial.
• Perform study-specific procedures and tasks under the supervision of the PI, Sub-I, and Clinical Trial Management with high quality.
• Screening, recruit, enroll prospective patients using EMR, EDC, CTMSCreate and maintain enrollment logs for each trial from beginning to end.
• Schedule, and follow up patient visits (clinician, infusion nurse, room, imaging, EKG, and all necessary tests ordered by the PI or Sub-I) and obtain patient results required for assigned trial.
• Collaborates with the cross functional team (RCCA front desk, pre-cert team, practice administrator, pharmacy tech, pharmacist, radiologist, nurse practitioner, registration nurse, phlebotomist, medical assistances, clinicians, PI, Sub-I, clinical management team, HQ) involved in the trial.
• Oversee study kits, study drug accountability records, study kits/IMP drug destruction and maintenance.
• Enter all the data to EDC, and EMR within 24 hours of data collection.
• Communicate and resolve all the data queries within 5-days
• Understand, monitor, and report patient safety, adverse events, serious adverse events, and protocol deviation within 24 hours of occurrence to PI, Sub-I, Clinical Trial Management, and Regulatory Coordinator.
• Avoidance of protocol deviations and reporting of adverse events.
• Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines at all times.
• Provide timely and complete updates to study team members regarding changes to workflow or patient-related specific needs by the protocol or SOP.
• Maintain accurate and complete records of all clinical trial activities.
• Monitor all clinical logistics including infusion chair assignments and EMR workflow is aligned with protocol requirements.
• Interacts with Research Sponsors, site personnel, IRBs (Institutional Review Boards), and other research entities regarding Regulatory and research study-related issues.
• Supports internal and external audits.
• Ability to take initiative to resolve protocol-related concerns and discrepancies.

Requirements

• Minimum 1 year of experience with oncology interventional clinical trials.
• ACRP (CCRC, CCRA) or SoCRA (CCRP) Certified Clinical Research Professional with one year of oncology trial experience.
• High School diploma with four years of oncology clinical trial experience.
• Computer literate with good interpersonal, writing, and verbal communication skills.
• Previous regulatory affairs experience is a plus.
• Must be available to work and travel onsite Monday to Friday from 9 am to 5 pm in all RCCA network.
• Prior experience working with centrifuge and handling biofluid specimens is preferred.
• Ability to multi-task and prioritize in a fast-paced work environment, time management skills, and ability to work well under pressure.

Employment Type

Full Time

Location

Sparta, NJ

Compensation

$27.09 - $36.54 per hour

Benefits

• Health, dental, and vision plans
• Wellness program
• Health savings account - Flexible spending accounts
• 401(k) retirement plan
• Life insurance
• Short-term disability insurance
• Long-term disability insurance
• Employee Assistance Program (EAP)
• Paid Time Off (PTO) and holiday pay
• Tuition discounts with numerous universities