Remote Medical Affairs Associate — Clinical Trials

Lancesoft; Santa Monica (CA); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Lancesoft is seeking a Medical Affairs Associate to support expanded access programs, trial operations, and regulatory compliance. The role emphasizes coordination of study deliverables, vendor management, and cross-functional communications with investigators and sites.

Remote role (West Coast preferred) with emphasis on supporting clinical trials from startup through closeout, ensuring adherence to ICH GCP, SOPs, and program requirements while tracking milestones and risks.

Qualifications

• BS/BA/RN in nursing, science, or a health-related field.
• 3–5 years of related Medical Affairs or Clinical Operations experience.
• Experience with regulatory compliance and ICH GCP.
• Familiarity with CTMS, eDC, RDMS.

Responsibilities

• Assists and manages clinical trials from startup to closure.
• Supports study regulatory documents and site communications.
• Manages vendors and external partners to meet timelines.
• Tracks milestones, risks, and program deliverables.
• Ensures activities align with regulations and SOPs.
• Supports expanded access and single-patient IND processes.
• Prepares metrics and status updates for management.
• Delivers training at investigator meetings as needed.

Skills

Clinical operations

Vendor management

Study start-up

Regulatory compliance

ICH GCP

CTMS

eDC

RDMS

Communication skills

Education

BS/BA/RN in nursing, science, or a health-related field

Tools

iMedidata/RAVE EDC

Job description

Lancesoft is seeking a Medical Affairs Associate to support expanded access programs, trial operations, and regulatory compliance. The role emphasizes coordination of study deliverables, vendor management, and cross-functional communications with investigators and sites.

Remote role (West Coast preferred) with emphasis on supporting clinical trials from startup through closeout, ensuring adherence to ICH GCP, SOPs, and program requirements while tracking milestones and risks.