Oncology Clinical Research Coordinator

📌Clinical Research Coordinator, Oncology

A leading community oncology practice is seeking a Clinical Research Coordinator to manage oncology clinical trials. This is a full time, onsite role where you will own assigned trials from start to finish and help bring cutting edge cancer treatments to patients close to home.

✅Responsibilities

• ✅Serve as the main point of contact for assigned oncology interventional trials, ensuring protocol requirements are understood and followed.
• ✅Screen, recruit, and enroll patients using EMR, EDC, and CTMS, and maintain enrollment logs for each study.
• ✅Schedule and track patient visits, infusions, imaging, EKGs, and labs required by the protocol.
• ✅Enter study data into EDC and EMR within 24 hours of collection and resolve data queries within 5 days.
• ✅Monitor and report adverse events, serious adverse events, and protocol deviations within 24 hours to the investigator and study leadership.
• ✅Oversee study kits, investigational drug accountability, and drug destruction records.
• ✅Process, ship, and store biological specimens according to sponsor protocols, IATA regulations, and biohazard precautions.
• ✅Assist with collecting and maintaining regulatory documents and support internal and external audits.
• ✅Attend sponsor visits including SIVs, IMVs, and COVs, and lead weekly and monthly trial meetings.
• ✅Collaborate with physicians, nurses, pharmacy, and clinic staff to keep workflows aligned with protocol requirements.
• ✅Track and submit patient reimbursement for clinical trial participation.

🎯Requirements

• 🔹At least 1 year of oncology interventional clinical trial experience.
• 🔹ACRP (CCRC or CCRA) or SoCRA (CCRP) certification preferred; a high school diploma with 4 years of oncology trial experience will also be considered.
• 🔹Working knowledge of ICH GCP, FDA, IRB, and HIPAA requirements.
• 🔹Experience with EDC, CTMS, and EMR systems.
• 🔹Experience with centrifuge operation and biospecimen handling preferred.
• 🔹Regulatory experience is a plus.
• 🔹Strong communication, organization, and time management skills with the ability to thrive in a fast paced clinic environment.