Clinical Research Coordinator II

Iterative Health•San Marcos, TX

About The Position

As a Clinical Research Coordinator II at Iterative Health, you will independently coordinate daily clinical trial activities and ensure compliance with protocol requirements, regulatory standards, and patient safety guidelines. You will manage complex studies with minimal oversight and partner with patients, investigators, sponsors, CROs, and internal teams to support high-quality study execution and enrollment success. The role covers clinical trials from start-up through closeout, including patient recruitment and retention, study visits and assessments, clinical procedures, specimen handling, study documentation, data entry, safety reporting, and preparation for monitoring visits, audits, and inspections. You will also help maintain site equipment and supplies, support process improvements, and may assist with onboarding and mentoring junior research staff.

Requirements

Associate’s or bachelor’s degree in a scientific, healthcare, or related discipline.
3–5 years of clinical research or healthcare experience.
Strong organizational skills and attention to detail.
Ability to manage competing priorities in a fast-paced environment.
Ability to read, interpret, and apply research protocols and clinic policies.
Proficiency with CTMS, EDC systems, and standard office software applications.

Nice To Haves

Experience in gastroenterology, hepatology, or cardiology therapeutic areas.
CCRC® (Certified Clinical Research Coordinator), CCRP® (Certified Clinical Research Professional), or equivalent clinical research certification.
Familiarity with CTMS or EDC systems.

Responsibilities

Independently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervision.
Manage complex study visit schedules and protocol-related activities while adhering to study timelines and requirements.
Lead patient recruitment and retention, including chart review, patient outreach, informed consent discussions, and enrollment tracking.
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, complete, 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 data queries in accordance with sponsor expectations and established timelines.
Serve as a primary point of contact for study participants throughout their participation.
Communicate with sponsors, CROs, investigators, site leadership, and internal teams to proactively resolve study-related issues.
Prepare for and support sponsor, CRO, and regulatory monitoring visits, audits, and inspections.
Review safety reports and ensure appropriate investigator review and documentation in a timely manner.
Maintain inventory and organization of onsite study equipment, supplies, and investigational products.
Contribute to process improvement initiatives to enhance site performance, operational efficiency, and patient experience.
Protect human research participants in compliance with federal regulations, GCP, HIPAA, and institutional policies.
Maintain compliance with site SOPs, privacy standards, and research protocols.
May support onboarding and mentorship of junior research staff and coordinators.
Perform job-related duties as requested.