Senior Clinical Research Coordinator - Dayton, OH
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What you'll do
- 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
What they're looking for
- 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
- 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
Nice to have
- CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification strongly preferred
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 CandidateAccommodations@iterative.health.
Company
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