Senior Clinical Research Coordinator - Providence, RI

The role

You will lead and manage complex industry-sponsored clinical trials from study start-up through closeout. You will also mentor junior coordinators and research staff, and act as a main contact for participants, sponsors, CROs and investigators.

What you will do

• Lead and independently manage complex industry-sponsored clinical trials from start-up through closeout
• Coordinate complex study visit schedules and protocol activities while meeting timelines and regulatory requirements
• Lead patient recruitment and retention initiatives
• Mentor and support junior coordinators and research staff
• Conduct protocol-required patient visits and assessments under GCP and site SOPs
• Perform protocol-required clinical procedures such as vital signs, ECGs, specimen collection and phlebotomy, where permitted
• Process lab specimens and prepare shipments under protocol and IATA rules
• Maintain accurate study documentation, including source records, consent forms, CTMS updates and case report forms
• Prepare for and support sponsor, CRO, regulatory monitoring visits, audits and inspections
• Maintain inventory of study equipment, supplies and investigational products onsite

Required qualifications

• Associate's or Bachelor's degree in a scientific, healthcare or related discipline
• 5+ years of clinical research or healthcare experience
• Able to perform blood draw, medical review (blood pressure, height, weight) and EKGs, as applicable by state law
• Strong understanding of GCP, FDA regulations and clinical research operations
• Demonstrated ability to independently manage complex clinical trials and competing priorities
• Experience mentoring or supporting junior research staff
• Strong written and verbal communication skills
• Strong organizational skills, attention to detail and problem-solving
• Proficiency with CTMS, EDC systems and standard office software
• Able to sit, stand and move for extended periods
• Able to lift and move up to 25 pounds

Nice to have

• CCRC or CCRP certification, or an equivalent clinical research certification

Before you apply

• Blood draw and EKG tasks depend on state law and the applicant's training

About the company

Iterative Health is a healthcare technology and services company that runs a network of 100+ research sites across the US, Europe, India and Australia. It is headquartered in Cambridge, Massachusetts, and New York City, with 250+ employees worldwide.