Job Type Full-time Description Clinical research study point of contact and accountable for coordination of each assigned trial from beginning to the end under the direction of the Principal Investigator, Sub-investigator, and Clinical Trial Management in adherence to the FDA, ICH-GCP, IRB, HIPAA, RCCA SOPs, US Oncology Compliance Program, RCCA Code of Ethics and Business Standards. 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, CTMS
- Create 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.
- Assist the regulatory coordinator in collecting all necessary regulatory documents to the such as CVs, 1572, Investigational Brochure Signature, Protocol Signature Page, GCP certificates, medical license, IATA, training records, DOA logs, CLIA certificates, radiology agreements, calibration records, EKG, -20 refrigerator, -80 drug ice storage for the specimens, temperature logs and other required essential documents
- 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
- 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. Generate solutions to barriers and opportunities for improvements.
- Centrifuge, process, prepare, ship, and store biological materials by the sponsor protocols, RCCA SOP, IATA, and universal biohazard precautions.
- Conduct clinical trial weekly and monthly meetings within the division.
- Require attending SIV, RMV, IMV, COV, and assigned trial ad-hoc meetings.
- Track and submit clinical trial patient reimbursement.
- Other duties as assigned.
Requirements
- 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.