Clinical Research Coordinator - 243747

Are you passionate about clinical research and eager to make a meaningful impact? We are looking for a motivated and dedicated Clinical Research Coordinator (CRC) to join our team. This is an exciting opportunity to take on a pivotal role in the success of clinical trial activities while ensuring compliance with regulations and guidelines. Working with a dynamic and collaborative team, you’ll have the chance to lead and support a range of clinical research studies that shape the future of healthcare.

Key Responsibilities:

• Lead Clinical Trials: Coordinate and manage clinical research studies of medium to high complexity, serving as the primary CRC while also supporting other coordinators as their Back-Up as needed.
• Maintain Trial Integrity: Ensure the quality and integrity of all clinical research trials are upheld throughout the process.
• Patient Recruitment: Develop and implement strategies for patient recruitment, working to meet enrollment targets effectively.
• Team Leadership: Oversee research assistants and provide guidance to junior team members as required.
• Collaboration: Work alongside multidisciplinary teams to ensure all study protocols and procedures are followed.
• Independent Problem Solving: Handle day-to-day responsibilities with autonomy, knowing when to seek additional support when necessary.
• Protocol Training: Complete all required protocol-related training and ensure compliance with study protocols.
• Participant Coordination: Schedule patient visits, collect medical histories, and maintain source documentation.
• Inventory Management: Track and manage study inventory, including investigational products, lab kits, and study supplies.
• Data Management: Enter data, resolve queries, and ensure that essential study documents are collected and reviewed.
• Safety and Compliance: Ensure the safety of participants, report adverse events, and coordinate all study procedures in compliance with IRB protocols.
• Study Visits: Facilitate site qualification, study initiation, monitoring visits, and close-out activities.
• Special Projects: Assist with special projects and, when needed, travel to other locations to support ongoing initiatives.
• Adherence to SOPs: Follow Clinic and Sponsor policies and procedures to maintain high-quality standards across all tasks.

Required Knowledge, Skills, and Abilities:

• CRC Expertise: Demonstrated ability to handle the responsibilities associated at a CRC experienced level
• Regulatory Knowledge: Proficiency in GCP/ICH guidelines and applicable regulatory standards.
• Site Operations Experience: Strong understanding of clinical trial operations and the drug development process.
• Communication Skills: Exceptional verbal and written communication skills, with the ability to engage with a diverse range of study participants.
• Teamwork and Adaptability: Collaborative mindset, open to new ideas, and responsive to challenges.
• Process Improvement: Willingness to contribute to continuous process improvement for efficiency and effectiveness.
• Tech-Savvy: Proficiency in Microsoft Word, Excel, and other relevant tools.

Overview

• Consenting, recruting, inputting data into EDC, regulatory, building relationships with physicians, phlebotomy (can train on this) and processing specimens
• Will be supporting 1-3 studies at a time
• Studies are multi therapeutic, Phase II-IV
• Working with adult and pediatric patient population

3-5 Must Have Skills/Qualifications

• One year of CRC experience
• High School Diploma

Nice to Have Skills

• Bachelors
• Bilingual in English and Spanish