Clinical Trials Coordinator

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Job Title:
Clinical Trials Coordinator

Details:
Full-Time, On-Site

Location:
Ellicott City, Maryland and Washington, DCEvon Medics, LLC is a medical device and neuroscience research company that develops innovative devices and therapeutics set to disrupt the healthcare industry. We are leading the development of Disease Modifying Therapies (DMT) for Alzheimer’s Disease, Opioid Use Disorder, Traumatic Brain Injury, Chronic Pain, and other neurological diseases that have remained elusive to treatment. Our breakthrough products have the potential to reap first-to-market benefits for a DMT in the markets we compete, and we are laser-focused on the commercialization and distribution of our products to help alleviate the sufferings of billions of patients all over the world.

Evon Medics, LLC is actively seeking a Clinical Trials Coordinator to join our innovative organization. The ideal candidate will participate in design, execution, analysis, and evaluation of research projects related to neuroscience grants awarded to Evon Medics, LLC. Projects will be developed in conjunction with the Translational Neuroscience Laboratory Director at Howard University – the collaborating institution. The candidate will perform tasks related to research projects independently, but within specific guidelines and subject to review by line manager or other senior research staff.Job

Summary:The Clinical Trials Coordinator (CTC) will be primarily responsible for facilitating, coordinating, and supporting daily clinical trial research activities and plays a critical role in the conduct of the study. CTC will also provide support in quality control review & clinical operations outreach to ensure compliance within protocol/research standards specific to clinical trial development, recruitment/outreach, research data collection, and general clinical operations.

CTC will actively contribute to the accurate retention of complex clinical data/records, by acting as Quality Control and Clinic Outreach Liaison maintaining organizational Standard Operating Procedures (SOPs) and Federal regulations as required. The Clinical Trials Coordinator will report to the Clinical Trials Program Manager.

Essential Duties and Responsibilities :

• Recruit, pre-screen and enroll study participants in accordance with individual protocols, in person or by telephone.
• Collect initial pre-screening health and demographic information by interviewing prospective participants to determine protocol eligibility.
• Screen prospective participants for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Coordinate participant tests and procedures
• Conduct informed consent process including discussions with research participants, and answering any questions related to the study. Obtain appropriate signatures and dates on forms in appropriate places. Ensure amended consent forms are appropriately implemented and signed. Perform Quality Control (QC) checks on all trials as needed.
• Collect data as required by the protocol. Ensure timely completion of Case Report Forms. Maintains study timelines. Report all adverse and serious adverse events to Director, PI and sponsor within 24 hours of learning of the occurrence.
• Maintain adequate inventory of study supplies including investigational devices, follow sponsor protocol and/or Research Policy on Investigational Device Accountability.
• Complete study documentation and maintain study files in accordance with sponsor requirements and Research policies and procedures including, but not limited to, consent forms, source documentation, notes, case report forms, and investigational material accountability forms.
• Identify potential problems or inconsistencies in documentation and execute data cleaning with precision in accordance with GCP mandates.
• Audit research records, source documentation and practices to monitor…