Medical Affairs Associate

ACL Digital; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

ACL Digital is seeking a Clinical Operations professional to support Medical Affairs activities across expanded access, single-patient INDs, and related programs. The role focuses on coordinating study and program deliverables, vendor management, and cross-functional communications to ensure regulatory alignment and timely execution.

The successful candidate will contribute to trial startup through closure, review essential documentation, manage timelines, and prepare program metrics, all while

Qualifications

• 3-5 years of related experience in clinical operations.
• Familiarity with clinical systems CTMS, eDC, RDMS.

Responsibilities

• Assists and manages clinical trials from startup to closure.
• Supports site and investigator communications and milestone tracking.
• Manages vendors and external partners to ensure timelines and deliverables are met.
• Ensures adherence to ICH GCP, study protocols, and regulatory requirements.
• Prepares metrics and status updates for management review.

Skills

Clinical operations

Vendor management

Regulatory compliance

Cross-functional teamwork

Education

BS/BA/RN in nursing or health-related field

Tools

CTMS

eDC

RDMS

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

Assists and manages clinical trials from startup to closure. Prior Clinical Operations experience is essential along with familiarity with clinical systems like CTMS, eDC, RDMS, and others.

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.