Senior Clinical Research Coordinator New Troy, MI

Iterative Health; Troy (MI); On-site; USD 80,000 - 110,000; Full time

Job summary

Iterative Health is seeking a Senior Clinical Research Coordinator to oversee complex industry-sponsored trials and support staff development. You will manage study start-up through closeout, coordinate visits, and ensure regulatory compliance while driving enrollment performance and data quality.

The role requires 5+ years in clinical research, a clinical degree, and strong GCP knowledge. Mentoring responsibilities and cross-functional collaboration are key components of this position.

Qualifications

• Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline.
• 5+ years of clinical research or healthcare experience required.
• CCRC® or CCRP® certification strongly preferred.
• Strong knowledge of GCP, FDA regulations, and clinical operations.

Responsibilities

• Lead and independently manage complex industry-sponsored trials from start-up to closeout.
• Coordinate study visits and protocol activities ensuring timelines and regulatory compliance.
• Lead patient recruitment and retention to meet enrollment goals.
• Mentor junior coordinators and research staff on processes and sponsor communication.
• Maintain accurate study documentation and data quality, including CTMS and CRFs.
• Prepare for sponsor/CRO monitoring visits and audits.

Skills

GCP knowledge

CTMS proficiency

EDC systems

Study coordination

Mentoring

Communication

Organization

Education

Bachelor's degree in science/healthcare

Associate's degree acceptable

Tools

CTMS software

EDC software

Job description

Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes.

We built a leading performance-driven network of 100+ sites across the US, Europe, India, and Australia, conducting research directly in the communities where care is delivered across gastrointestinal, hepatology, obesity, and cardiology. By combining deep clinical trial expertise with cutting-edge AI, we connect sponsors' scientific ambitions with high-performing research teams that expedite and expand access to novel therapeutics for patients in need. Today, Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.

As a Senior Clinical Research Coordinator (Sr. CRC) at Iterative Health you will serve as a key team member within the clinical research site, overseeing complex studies while supporting staff development, operational performance, and high-quality patient experiences.

This role combines hands-on study coordination with mentorship, process improvement, and cross-functional collaboration to help drive successful study execution, enrollment performance, and regulatory compliance.

Where You’ll Drive Impact

• Lead and independently manage complex industry-sponsored clinical trials from study start-up through closeout
• Coordinate complex study visit schedules and protocol-related activities while ensuring compliance with study timelines and regulatory requirements
• Lead patient recruitment and retention initiatives to support enrollment performance and patient engagement goals
• Mentor and support junior coordinators and research staff on clinical trial processes, patient interactions, sponsor communication, and operational best practices
• Conduct protocol-required patient visits and assessments in accordance with study protocols, GCP guidelines, and site SOPs
• Perform protocol-required clinical procedures including vital signs, ECGs, specimen collection, investigational product accountability, and phlebotomy, as permitted by applicable regulations, training, and organizational policy
• Process laboratory specimens and prepare shipments in accordance with protocol requirements and applicable IATA regulations
• Maintain accurate and timely study documentation including source records, informed consent forms, CTMS updates, and case report forms
• Ensure high-quality data entry and timely resolution of sponsor and CRO data queries
• Serve as a primary point of contact for study participants, sponsors, CROs, investigators, and site leadership
• Build strong relationships with investigators, referring physicians, sponsors, and CRO partners to support study success and patient engagement
• Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections
• Review safety reports and ensure timely investigator review and documentation
• Maintain inventory and oversight of study equipment, supplies, and investigational products onsite
• Assess operational challenges, identify solutions, and recommend process improvements to enhance site performance and protocol adherence
• Support site performance initiatives related to enrollment, screen failures, protocol compliance, and patient retention
• Contribute to onboarding, training, and mentorship activities for new research staff
• Support the protection of human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies
• Maintain compliance with all site SOPs, privacy standards, and research protocols
• Perform job related duties as requested

What You Bring to the Team

• Associate’s or Bachelor’s degree in a scientific, healthcare, or related discipline required
• 5+ years of clinical research or healthcare experience required
• Must be able to perform blood draw, medical review (blood pressure, height, weight etc.) & EKGs, as applicable by state law
• CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification strongly preferred
• 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 capabilities
• Proficiency with CTMS, EDC systems, and standard office software applications

Physical Requirements

• Ability to sit, stand, and move throughout clinical and office environments for extended periods of time
• Ability to lift and move up to 25 pounds as needed

At Iterative Health, we’re actively working towards creating an environment that is representative of the diversity of patients our technology serves. We are focused on building an equitable and inclusive culture, and by extension, hiring process. If you require any accommodations to make the application process or interviewing experience more accessible to you, please contact [e-mail].

Equal Employment Opportunity Statement

Iterative Health (the “Company”) is proud to be an equal opportunity employer, and is committed to providing equal employment opportunities to all employees and applicants without regard to actual and/or perceived: race; color; national origin; religion; age; sex (including pregnancy, childbirth, breastfeeding, and related medical conditions); gender identity or expression (including transgender status); affectional or sexual orientation; disability (mental and physical); atypical hereditary cellular or blood trait or genetic information (including family medical history); uniform service member and veteran status; participation in legally protected conduct or making a complaint relating to unlawful conduct; and any other characteristic or conduct protected by applicable federal, state, or local law.