Clinical Research Coordinator II - Birmingham, AL

About the role

Clinical Research Coordinator II - Birmingham, AL at Iterative Health. At Iterative Health, we are at the forefront of healthcare technology and services, focusing on enhancing clinical research to improve patient outcomes. As a Clinical Research Coordinator II, you will play a vital role in overseeing clinical trials, ensuring that all protocols are followed meticulously while prioritizing patient safety. This position requires a high degree of independence in managing complex studies and collaborating with various stakeholders to ensure the successful execution of trials and effective participant enrollment.

Key facts Location: Birmingham, Alabama Engagement: Full-time Team: Clinical Research

What you'll do

• Lead and coordinate industry-sponsored clinical trials from start to finish with minimal oversight, ensuring all phases are executed efficiently.
• Develop and manage complex study visit schedules, ensuring strict adherence to study protocols and timelines.
• Spearhead patient recruitment and retention strategies, which include conducting chart reviews, outreach efforts, facilitating informed consent discussions, and monitoring enrollment metrics.
• Perform necessary patient visits and assessments in accordance with study protocols and Good Clinical Practice (GCP) standards.
• Carry out clinical procedures such as checking vital signs, conducting ECGs, collecting specimens, managing investigational products, and performing phlebotomy, as permitted by training and regulations.
• Process and ship laboratory specimens according to protocol requirements and IATA regulations to ensure compliance.
• Maintain comprehensive and accurate study documentation, including source records, consent forms, updates to the Clinical Trial Management System (CTMS), and case report forms.
• Ensure accurate data entry and promptly address any data inquiries to meet sponsor expectations.
• Serve as the primary point of contact for study participants throughout their trial involvement, providing support and information as needed.
• Regularly communicate with sponsors, Contract Research Organizations (CROs), investigators, and internal teams to proactively resolve study-related issues.
• Prepare for and assist during monitoring visits, audits, and inspections conducted by sponsors and regulatory authorities.
• Review safety reports and ensure timely investigator review and documentation to maintain participant safety.
• Organize and manage study equipment, supplies, and investigational products on-site to ensure operational readiness.
• Contribute to initiatives aimed at enhancing site performance and operational efficiency while improving the overall patient experience.
• Uphold the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies.
• Follow all site standard operating procedures (SOPs), privacy standards, and research protocols diligently.
• Potentially assist in onboarding and mentoring junior research staff and coordinators to foster team development.
• Undertake additional related duties as assigned to support the research team and project goals.

Requirements

• An Associate's or Bachelor's degree in a scientific, healthcare, or a related discipline is required.
• A minimum of 3-5 years of experience in clinical research or a healthcare setting is essential.
• Previous experience in therapeutic areas such as gastroenterology, hepatology, or cardiology is preferred.
• Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Associate (CCRP) or an equivalent credential is advantageous.
• Strong organizational abilities and meticulous attention to detail are crucial for success in this role.
• Ability to prioritize tasks and manage multiple responsibilities in a dynamic environment is necessary.
• Proficiency in reading, interpreting, and applying research protocols and clinical policies is required.
• Familiarity with CTMS, Electronic Data Capture (EDC) systems, and standard office software is essential.
• Experience with CTMS or EDC systems is a plus.

Physical Requirements

• Must be capable of sitting, standing, and moving throughout clinical and office environments for extended periods.
• Ability to lift and carry up to 25 pounds as needed for various tasks.

Practical notes

Iterative Health is dedicated to creating a diverse and inclusive workplace that mirrors the communities we serve. If you require any accommodations to assist with your application or interview process, please contact CandidateAccommodations@iterative.health.