Oncology Clinical Trial Coordinator

Regional Cancer Care Associates; Freehold (NJ); Vor Ort; USD 37.195 - 49.593; Vollzeit

Zusammenfassung

Regional Cancer Care Associates (RCCA) is actively seeking a Research Coordinator to oversee assigned oncology clinical trials from start to finish. You will manage protocol elements, patient recruitment, data entry, and regulatory document collection under the Clinical Trial Management leadership, working with a cross-functional RCCA team.

The role requires experience in oncology trials, SCRP/CCRP or SoCRA certification is preferred, and a commitment to on-site work Monday through Friday in our

Qualifikationen

• 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.
• Must be available to work onsite Monday to Friday from 9 am to 5 pm in RCCA network.

Aufgaben

• 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, CTMS
• Create and maintain enrollment logs for each trial from beginning to end
• Schedule, and follow up patient visits and obtain patient results required for assigned trial.
• Collaborates with the cross functional team 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
• Assist the regulatory coordinator in collecting regulatory documents
• Ensure compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB, FDA, and ICH-GCP guidelines
• Provide updates to study team regarding changes to workflow or patient-related needs
• Monitor all clinical logistics including infusion chair assignments
• Interacts with Research Sponsors, site personnel, IRBs, and other research entities
• Supports internal and external audits
• Ability to take initiative to resolve protocol-related concerns and generate solutions
• Centrifuge, process, ship, and store biological materials per sponsor protocols
• Conduct clinical trial weekly and monthly meetings
• Attend SIV, RMV, IMV, COV meetings
• Track and submit clinical trial patient reimbursement
• Other duties as assigned.

Kenntnisse

Oncology interventional clinical trial

ACRP/SoCRA certified

Ausbildung

High School diploma with four years of oncology clinical trial experience

Jobbeschreibung

Regional Cancer Care Associates (RCCA) is actively seeking a Research Coordinator to oversee assigned oncology clinical trials from start to finish. You will manage protocol elements, patient recruitment, data entry, and regulatory document collection under the Clinical Trial Management leadership, working with a cross-functional RCCA team.

The role requires experience in oncology trials, SCRP/CCRP or SoCRA certification is preferred, and a commitment to on-site work Monday through Friday in our