Clinical Affairs Associate

Integrated Resources, Inc ( IRI ); United States; Remote; USD 42,000 - 59,000; Full time

Job summary

Integrated Resources, Inc ( IRI ) is seeking a Clinical Operations professional to support medical affairs activities, including expanded access and single-patient IND processes. The role focuses on coordinating study deliverables, managing vendors, and communicating with sites and investigators to ensure regulatory alignment and timely milestones.

The candidate will assist in startup-to-closure in clinical trials, review essential documents, and help execute program plans with strong attention

Qualifications

• BS/BA/RN in nursing, science or a health-related field with 3-5 years of related experience.
• Experience in oncology/hematology and cellular therapy is a plus.
• Familiarity with clinical systems like CTMS, eDC, RDMS.

Responsibilities

• Assist and manage clinical trials from startup to closure.
• Coordinate study- and program-related deliverables and vendor communications.
• Support site communications, track milestones and risks, ensure regulatory alignment.
• Prepare site newsletters and trial-related correspondence with the study team.
• Provide training at investigator meetings and site initiation visits.

Skills

Clinical operations

CTMS

eDC

RDMS

Vendor management

Cross-functional communication

Study start-up

ICH GCP knowledge

Education

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

Tools

iMedidata/RAVE EDC

CTMS

EDC systems

Job description

Job Duration: 12 months (Possibilities for extension)

Pay rate: $36.71/hour on W2.

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.