Medical Affairs

LanceSoft Inc

Santa Monica, CA

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JOB DETAILS

SALARY

$36.72 Per Hour

SKILLS

Apheresis, Best Practices, Brochures, Case Report Form (CRF), Clinical Practices/Protocols, Clinical Support, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Cross-Functional, Database Analysis, Detail Oriented, Documentation, Electronic Data Capture (EDC), Establish Priorities, Feasibility Analysis, GCP (Good Clinical Practices), Hematology, ICH Regulations, Informed Consent, Interpersonal Skills, Medical Affairs, Metrics, Multitasking, Newsletter, Oncology, Operational Communications, Organizational Skills, Patient Care, Pharmacy, Presentation/Verbal Skills, Problem Solving Skills, Program Planning, Query Analysis, Registered Nurse (RN), Regulations, Research Protocols, Site Evaluation, Site Initiation, Small Company, Specification Programming Languages, Startup, Support Documentation, Team Player, Teleconferencing, Training/Teaching, Vendor/Supplier Management, Writing Skills

LOCATION

Santa Monica, CA

POSTED

20 days ago

Official Job Title: : Medical Affairs Associate
Location: Santa Monica or El Segundo (Onsite/ Hybrid)
Contract Duration: 12 Months
Pay Range: $30.00 - $36.72 USD hourly on W2

Job Description:
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
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.

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

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