Medical Affairs - II*

The Fountain Group; Lemon Grove, Tampa (CA, FL); Remote; USD 41,000 - 58,000; Part time

Job summary

The Fountain Group is seeking a Medical Affairs Associate for a remote role on a 1-year contract. West Coast preferred. This position supports expanded access programs, OOS processes, and single-patient IND activities, coordinating study activities and external partnerships.

Responsibilities include trial support from start-up to closeout, vendor management, and ensuring ICH-GCP and regulatory compliance. A healthcare or life sciences background and RN options are considered.

Qualifications

• Bachelor's degree in Nursing, Life Sciences, or related healthcare/scientific discipline preferred.
• Associate degree with an active RN license may be considered.
• RN candidates with relevant clinical operations experience are encouraged to apply.

Responsibilities

• Support clinical trials and expanded access programs from study start-up through closeout.
• Coordinate study-related documentation, timelines, milestones, and deliverables for expanded access and single-patient IND requests.
• Review clinical study documents, including protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, and case report forms.
• Manage CROs, vendors, and external partners to ensure timely execution of assigned activities.
• Coordinate site feasibility assessments, investigator communications, and site-specific activities.
• Track screening, enrollment, data flow, protocol deviations, and other clinical program milestones.
• Identify program risks, support issue resolution, and upscale operational challenges.
• Prepare program metrics, status reports, site newsletters, and clinical study communications.
• Support clinical data queries, interim analyses, and final database lock activities.
• Ensure compliance with ICH-GCP, clinical study protocols, and applicable regulatory requirements.

Skills

Clinical operations

Study coordination

Vendor management

Regulatory compliance

ICH-GCP

Education

Bachelor's degree in Nursing/Life Sciences or related

RN license (active)

Associate degree with RN license may be considered

Job description

The Fountain Group iscurrently seeking a Medical Affairs Associate for a prominent client of ours. This position is Remote.Details for the position are as follows: Medical Affairs Associate Location: Remote (West Coast Preferred) Pay Rate: $36/hr Duration: 1-Year Contract (Extension or Conversion Potential) Shift: Normal Business Hours

Job Description

Seeking a Medical Affairs Associate to support expanded access programs, out-of-specification (OOS) programs, and single-patient IND processes. This role supports clinical operations and treatment-use activities through study coordination, vendor management, site communications, and clinical program execution.

• Support clinical trials and expanded access programs from study start-up through closeout.

• Coordinate study-related documentation, timelines, milestones, and deliverables for expanded access and single-patient IND requests.

• Review clinical study documents, including protocols, informed consent forms, investigator brochures, pharmacy manuals, monitoring plans, and case report forms.

• Manage CROs, vendors, and external partners to ensure timely execution of assigned activities.

• Coordinate site feasibility assessments, investigator communications, and site-specific activities.

• Track screening, enrollment, data flow, protocol deviations, and other clinical program milestones.

• Identify program risks, support issue resolution, and upscale operational challenges.

• Prepare program metrics, status reports, site newsletters, and clinical study communications.

• Support clinical data queries, interim analyses, and final database lock activities.

• Ensure compliance with ICH-GCP, clinical study protocols, and applicable regulatory requirements.

Education

• Bachelor's degree in Nursing, Life Sciences, or a related healthcare/scientific discipline preferred.

• Associate degree with an active RN license may be considered.

• RN candidates with relevant clinical operations experience are encouraged to apply.