Medical Affairs - II*

Position Overview

We are seeking a Medical Affairs Associate to support expanded access programs, single-patient IND activities, and clinical operations. This role will coordinate program execution, manage vendors and study deliverables, and support investigator and site communications.

Key Responsibilities

  • Support clinical studies, expanded access programs, and single-patient IND activities.
  • Coordinate timelines, documentation, communications, and program milestones.
  • Manage vendors, CROs, and external partners.
  • Track enrollment, study metrics, protocol deviations, and key deliverables.
  • Support study start-up, site feasibility, and investigator interactions.
  • Identify risks, support issue resolution, and provide program status updates.
  • Ensure compliance with ICH-GCP and study requirements.

Required Qualifications

  • BS/BA/RN in Nursing, Life Sciences, or a related healthcare field.
  • 3-5 years of experience in Clinical Operations, Medical Affairs, or clinical research.
  • Experience supporting clinical trials, expanded access programs, or treatment-use programs.
  • Familiarity with CTMS, EDC, and clinical trial systems.
  • Knowledge of ICH-GCP and clinical trial operations.
  • Strong organizational, communication, and project coordination skills.

Preferred Qualifications

  • Experience in oncology, hematology, or cellular therapy.
  • Experience with study start-up, site management, or regulatory activities.
  • Experience with Medidata Rave or similar EDC platforms.

#MSPTalent
#LI-VB1

 

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].