Clinical Operations Associate

Integrated Resources, Inc ( IRI ); California; Remote; USD 90,000 - 130,000; Full time

Job summary

Integrated Resources, Inc. is seeking a Medical Affairs Associate to support activities related to expanded access programs, single-patient INDs, and trial execution. Remote role with West Coast preference.

The role involves coordinating study- and program-related deliverables, managing vendors and external partners, and ensuring alignment with regulatory requirements and internal procedures.

Qualifications

• BS/BA/RN in nursing, science, or a health-related field with 3–5 years of related experience.
• Ability to manage competing time demands and adapt to changing priorities.
• Excellent interpersonal, verbal, and written communication skills.

Responsibilities

• Supports Medical Affairs activities related to expanded access programs and single-patient IND processes.
• Coordinates study- and program-related deliverables and tracks milestones and risks.
• Manages vendors and external partners to ensure timelines and performance expectations are met.
• Assists in preparing materials for investigator meetings and site communications.
• Ensures activities comply with ICH GCP, protocols and applicable requirements.

Skills

Clinical operations

Regulatory compliance

Analytical skills

Attention to detail

Project coordination

Communication skills

Education

BS/BA or RN in nursing/science/health field

Tools

CTMS

iMedidata RAVE EDC

Job description

Official Job Title: Medical Affairs Associate

Location: Remote (West Coast preferred)

This role supports Medical Affairs activities related to expanded access programs, out-of-specification case support, and single-patient IND processes. The individual contributes to the operational execution of treatment-use and clinical support activities by coordinating study- and program-related deliverables, managing vendors and external partners, supporting site and investigator communications, tracking key milestones and risks, and helping ensure activities are conducted in alignment with applicable regulations, internal procedures, and program requirements.

Key Responsibilities

• Assists and manages clinical trials from startup to closure. Prior Clinical Operations experience is essential along with familiarity with clinical systems like CTMS, eDC, RDMS, and others.
• May assist in the review of study-related and essential start-up documents, as delegated by the study manager, including clinical protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, case report forms, CRF completion guidelines, and other relevant study plans and charters.
• With guidance, plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study team.
• Supports activities associated with out-of-specification programs, expanded access programs, and single-patient IND requests, including coordination of timelines, documentation, communications, and cross-functional follow-up.
• Manages vendors and works with multiple contract research organizations and external partners to communicate detailed timelines, oversee transferred obligations, and ensure performance expectations are met; provides corrective instruction as needed when expectations are not met.
• Attends internal team meetings and other required meetings to support program planning, issue resolution, and execution.
• Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconferences.
• Creates and reviews site feasibility assessments required for participation, where applicable.
• Manages and tracks key deliverables such as screening, enrollment, data flow, protocol deviations, and other program milestones.
• Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior management.
• Prepares metrics and status updates on key deliverables for management review.
• Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicable.
• Prepares site newsletters and other correspondence related to clinical trial or program conduct, including best practices, lessons learned, and frequently asked questions, in collaboration with the study team.
• Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to ICH GCP, study protocols, and applicable treatment-use requirements.
• May participate in special projects and other duties as assigned.
• Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational execution.

Basic Qualifications

• BS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experience.

Preferred Qualifications

• Oncology/hematology experience preferred; cellular therapy experience is a plus.
• Experience with iMedidata/RAVE EDC is a plus.
• Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role is a plus.
• Ability to manage competing time demands, incomplete information, and unexpected events.
• Strong analytical and problem-solving skills.
• High attention to detail.
• Outstanding organizational skills with the ability to multitask and prioritize effectively.
• Excellent interpersonal, verbal, and written communication skills in a collaborative work environment.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
• Working knowledge of transplant patient care and apheresis collection is a plus.