Job Title: Clinical Trials Coordinator
Details: Full-Time, On-Site
Location: Ellicott City, Maryland and Washington, DC
Evon 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.
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
- Identify potential problems or inconsistencies in documentation and execute data cleaningwith precision in accordance with GCP mandates.
- Audit research records, source documentation and practices to monitor compliance with applicable regulations. Identify areas of potential risk through audit processes, as well as assist with presentation of audit findings and design and monitoring of necessary corrective action.
- Ensure clinical notes adhere to protocol requirements, accurate input of clinical data and records information, aligning database cross-communications to secure data integrity.
- Verify consistency of trial data with participant clinical notes and other source documentation (source data verification/review).
- Identify training opportunities based on audits, design and present such education to prevent repeated compliance risks.
- Assist in providing monitoring support for all facets of clinical trials and research.
- Perform internal QC monitoring visits to ensure accuracy of the research data, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documents.
- Enter information and communications in REDCap database to secure data integrity.
- Respond and follow up to initial inquires through email and calls.
- Participate in regular team group meetings and provide data control and clinical recruitment insight and recommendations to improve performance.
- Assist with writing and editing NIH grants, scientific publications, research manuscripts, and IRB and IBC protocols for approval by medical school committees.
- Assist with the day-to-day clinical administrative tasks, such as copying, filing, and clinical data entry; maintain tools and supplies to ensure proper recruitment for research studies. Maintains effective and ongoing communication with sponsor, research participants, Director
and PI during the course of the study.
- Assist in preparation of any modifications to the protocol in accordance with Federal regulations and sponsoring agency policies and procedures. Assist in submission of accurate and timely closeout documents to applicable Federal agencies and the sponsoring agency in accordance with Federal regulations and sponsoring agency policies and procedures.
- Arrange secure storage of study documents that will be maintained according to Good Clinical Practice (GCP) guidelines or for the contracted length of time, whichever is longer
Required Skills and Experience:
- Bachelor’s degree in clinical field or health sciences
- Experience working in a Phase I/phase II / phase III sponsored clinical trial (min. 2 years)
- Clinical research experience and experience working in a medical center or private practice (Opioid Use Disorder or Alzheimer’s study experience is a plus)
- Experience working with REDCap and VivaVault
- Excellent communication and problem-solving skills
- Must be able to interact effectively with study participants from diverse backgrounds
- Student mentality, strong listening, organizational, multi-tasking, and interpersonal skills
- Travel – up to 10% regional
If you believe you have a strong candidacy for this role, kindly send your resume and cover letter to email@example.com with the subject line “Clinical Trials Coordinator.” Also indicate your earliest start date, if considered for the role.
View the company website https://www.evonmedics.com and our LinkedIn page
https://www.linkedin.com/company/evon-medics-llc for more information about Evon Medics.