What are the responsibilities and job description for the Oncology Clinical Research Coordinator position at ClinLab Solutions Group?
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.
Salary : $65,000 - $70,000