Overview
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the planning, execution, and management of clinical trials to ensure compliance with regulatory standards and scientific rigor. Your expertise will help advance innovative healthcare solutions, improve patient outcomes, and contribute to groundbreaking research initiatives. This position offers an exciting opportunity to work in a collaborative environment dedicated to excellence in clinical research.
About Us:
At NextPhase Research Florida we are dedicated to advancements in medical research. Our team is passionate, collaborative, and committed to upholding the highest ethical standards in all our endeavors. We are located in Hollywood, FL, and are eager to welcome new talent who can contribute to our mission.
Responsibilities
- Coordinate and manage all aspects of clinical trials, including participant recruitment, scheduling, and follow-up procedures.
- Ensure adherence to FDA regulations, ICH Good Clinical Practice (GCP) guidelines, and institutional policies throughout the research process.
- Review and verify documentation such as consent forms, case report forms, and study protocols for accuracy and completeness.
- Monitor patient progress by conducting regular assessments, recording data accurately, and managing adverse event reports.
- Document clinical activities in source charts, enter data in Electronic Data Capture (EDC) systems, and address queries promptly to maintain data integrity.
- Collaborate with investigators, healthcare professionals, and regulatory bodies to ensure compliance with clinical ethical guidelines and healthcare standards.
- Perform essential clinical procedures, including obtaining vital signs, conducting ECGs, and executing basic lab procedures such as blood specimen collection and processing.
- Conduct monitoring visits, resolve issues in a timely manner, file Serious Adverse Event (SAE) and deviation reports with sponsors and IRBs, and document and report adverse events and non-compliance issues as necessary.
- Complete study start-up activities, prepare for site initiation visits and investigator meetings, and train on technology needed for studies.
Qualifications
- Medical Assistant diploma, LPN/LVN, EMT credential, or Associate’s degree with a minimum of 2 years of clinical research or clinical experience; equivalent combinations of education and experience are acceptable.
- Proven supervising experience in a clinical research or healthcare setting.
- Strong knowledge of medical terminology, clinical laboratory procedures, and research methods.
- Experience reviewing documentation for accuracy and compliance with clinical research protocols.
- Proficiency in statistical software, Microsoft Office Suite, and data management tools such as CDISC standards or EMR systems.
- Familiarity with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and healthcare compliance standards.
- Clinical laboratory experience or blood sampling expertise is highly desirable.
- Certification in ICH GCP from a recognized issuer (e.g., CA) is required; additional certifications in clinical development or project management are advantageous.
- Excellent analysis skills coupled with strong organizational abilities to manage multiple projects efficiently.
- Knowledge of clinical quality assurance standards and research project management best practices.
- Bilingual (English/Spanish) proficiency is a plus.
Join us to be part of a forward-thinking organization committed to advancing healthcare through meticulous research practices! We value energetic professionals who thrive in collaborative environments dedicated to scientific integrity and patient safety. .
Pay: From $65,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- What was your role in the clinical trial process from startup to closeout?
- Do you have experience working on Central Nervous System (CNS) clinical research studies, including psychiatry, neurology, or related therapeutic areas?
- If yes, which psychiatry/CNS studies have you worked on? Please list the study indications (MDD, Bipolar Disorder, Schizophrenia, Alzheimer's Disease, ADHD, Anxiety, PTSD, OCD, etc.) Briefly describe your role in those studies.
Experience:
- Clinical research: 2 years (Required)
Language:
Work Location: In person
