Medical Affairs Associate

Job Title: : Medical Affairs Associate

Location: Santa Monica or El Segundo, CA (Onsite/ Hybrid)

Duration: 12 Months

Pay rate: 37/hr on w2

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

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Key Responsibiliti

esMay 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 charter

s.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 tea

m.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-u

p.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 me

t.Attends internal team meetings and other required meetings to support program planning, issue resolution, and executio

n.Provides training, as needed, at investigator meetings and other trial- or program-specific meetings, such as site initiation visits and monthly teleconference

s.Creates and reviews site feasibility assessments required for participation, where applicabl

e.Manages and tracks key deliverables such as screening, enrollment, data flow, protocol deviations, and other program milestone

s.Proactively identifies potential study or program issues and risks, recommends and implements solutions, and escalates issues appropriately to senior managemen

t.Prepares metrics and status updates on key deliverables for management revie

w.Assists in the resolution of clinical trial queries for interim analyses, primary analyses, and final database locks, as applicabl

e.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 tea

m.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 requirement

s.May participate in special projects and other duties as assigne

d.Applies standard medical and scientific terminology appropriately in support of documentation, communication, and operational executio

n.
Basic Qualificati

onsBS/BA/RN in nursing, science, or a health-related field with 3-5 years of related experien

ce.
Preferred Qualificat

ionsOncology/hematology experience preferred; cellular therapy experience is a p

lus.Experience with iMedidata/RAVE EDC is a p

lus.Study start-up experience from a prior site-based regulatory role, CRO role, or sponsor role is a p

lus.Ability to manage competing time demands, incomplete information, and unexpected eve

nts.Strong analytical and problem-solving ski

lls.High attention to det

ail.Outstanding organizational skills with the ability to multitask and prioritize effectiv

ely.Excellent interpersonal, verbal, and written communication skills in a collaborative work environm

ent.Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorit

ies.Working knowledge of transplant patient care and apheresis collection is a p