Clinical Trials Site Operations Lead

Iterative Health; Webster (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Iterative Health is seeking a Research Site Manager to run day-to-day trials across multiple sites, lead staff, and drive enrollment performance. You will ensure quality, compliance, and efficiency while solving operational challenges and filling in as a backup CRC when needed.

You will manage employee lifecycle, training, and performance, coordinate with CROs and sponsors, and work with Principal Investigators to promote opportunities for patients. Travel to sites and meetings is expected.

Qualifications

• Bachelor's degree in science preferred or equivalent.
• Minimum 3 years as senior Clinical Research Coordinator; some management experience preferred.
• Strong written and verbal communication skills.
• Ability to read, interpret, and apply clinic policies and research protocols.
• Proficiency in EMR and CTMS platforms.

Responsibilities

• Manage day-to-day activities across research site(s), including staff management, problem-solving, and operational planning.
• Create and implement standardized, well-documented clinic workflows that drive operational excellence and support site goal achievement.
• Attend all site selection visits and site initiation visits (SIVs).
• Oversee inventory of study supplies and ensure adequate stock levels at all times.
• Manage site-level purchasing and expenses in line with cost guidelines and profitability goals.
• Act as assigned or backup CRC as needed to manage team workloads while prioritizing site leadership responsibilities.
• Own the full employee lifecycle for site staff (CRCs and RAs), including hiring, onboarding, assignments, development, performance reviews, and offboarding.
• Ensure timely completion of tasks in EMR and CTMS by CRCs and RAs.
• Lead onsite training of clinical operations staff, including onboarding and study initiation visits.
• Monitor timelines and address issues when performance standards are not met.
• Review, approve, and submit timesheets.
• Work closely with Iterative Health management to develop strategies to meet performance targets around study enrollment, timeliness, and overall site health.
• Meet assigned productivity and quality metrics; meet regularly with coordinators to ensure they meet goals and elevate systemic barriers to the Iterative Health central team.
• Follow up on all monitoring visit action items in a timely manner.
• Maintain effective and ongoing communication with CROs and sponsors.
• Work closely with Principal Investigators and referring physicians to build understanding and enthusiasm for research opportunities for patients.
• Maintain effective communication between site staff, Principal Investigators, and Iterative Health management, including conducting regular site research meetings to discuss study progress and enrollment.
• Identify and manage appropriate third-party vendors; partner with the central Iterative Health team to ensure contracts are fully executed prior to study activation.
• Protect the rights and welfare of all human research participants involved in research.
• Cooperate with Iterative Health research compliance and monitoring efforts regarding the access, use, and disclosure of PHI; report instances of noncompliance to the appropriate compliance office.
• Assess problem situations to identify causes, gather and process relevant information, generate possible solutions, and make recommendations to management.
• Performs related duties as requested

Skills

Clinical Research

Team Leadership

Communication

EMR/CTMS

Problem Solving

Education

Bachelor's degree in science

Tools

EMR

CTMS

Salesforce

Job description

Iterative Health is seeking a Research Site Manager to run day-to-day trials across multiple sites, lead staff, and drive enrollment performance. You will ensure quality, compliance, and efficiency while solving operational challenges and filling in as a backup CRC when needed.

You will manage employee lifecycle, training, and performance, coordinate with CROs and sponsors, and work with Principal Investigators to promote opportunities for patients. Travel to sites and meetings is expected.