Job description Clinical Research Coordinator Between Morristown & Hackensack, NJ Offices •Prior Clinical Coordinator experience preferred•Northeast Regional Epilepsy Group is a private practice group treating patients with epilepsy. In addition to providing antiseizure medications and surgery as treatment options for patients with medically refractory epilepsy, we are also providing clinical trials. We are looking for an experienced clinical coordinator to grow this aspect of our research department. Qualified candidates will be able to review the clinical trial, study procedures, and schedule with patients, perform informed consent, coordinate and perform subject visits, perform study procedures, identify/record adverse events, perform drug accountability, dispense study medication, document all information necessary in paper or electronic source documents in a timely and accurate manner. Ability to maintain the investigator site file and other essential regulatory documents/procedures is a great addition. Ability to perform EKGs, and obtaining labs is also a good skill to have, but not required. The Clinical Research Coordinator will be responsible for the day-to-day coordination and conduct of assigned clinical trials in accordance with the study protocol, ICH-GCP guidelines, applicable regulatory requirements, and institutional policies and procedures. The coordinator will serve as a primary point of contact for study participants and caregivers and will work closely with the Principal Investigator and study team to ensure participant safety, protocol compliance, data quality, and timely completion of study activities.

Essential Duties:

Serve as a primary point of contact for study participants and caregivers throughout their participation in clinical trials. Discuss the clinical trial, study procedures and schedule with patients. Perform informed consent and keep track of final informed consent forms and amendments through the IRB portal. Provide study-related education and training to participants and caregivers, including training on seizure diaries, medication administration, study procedures, and other protocol requirements as applicable. Coordinate study visits, including scheduling within protocol-required visit windows and communicating study requirements and procedures to participants and caregivers. Perform study procedures including vital signs, EKGs, questionnaires, training patients in keeping study diaries, performing other study end points, obtaining and processing labs, shipping/storing specimen. Document accurate information including medical history, current and past anti-seizure medications, study procedures as above in source documents and EDC. Record/identify all adverse events and report if necessary.

Drug Accountability Drug Dispensing Maintenance of Investigator Site File:

maintaining essential documents as per FDA, keeping track of protocol deviations, waivers, violations. Assist investigators in self-monitoring, preparing corrective action plans, ensuring implementation and adherence to stated plan. Assist investigators by providing updates regarding protocols, obtaining signatures on labs, EKGs, adverse events, and other documents. Ensure adherence to the clinical trial protocol and identify and report instances of noncompliance or deviations. Facilitate monitoring visits, internal audits, and complete action items from monitor follow up letters. Ensure accurate and timely data collection and entry into electronic data capture (EDC) systems; respond to queries and reconcile discrepancies as needed. Assist with regulatory tasks such as maintaining essential documents in study binders and assisting with IRB submissions and correspondence. Other duties as assigned by research director/manager.

Pay:

$65,000.00 - $75,000.00 per year

Benefits:

401(k) Dental insurance Health insurance Paid time off

Work Location:

In person