Job Description

The Enrollment Specialist serves as the initial point of contact for prospective clinical trial participants. This role is responsible for initiating timely outreach, conducting protocol-driven medical pre-screening, and coordinating next steps in the enrollment process. Success in this role directly impacts study enrollment through accurate eligibility assessment, efficient lead follow-up, and high-quality participant engagement.

Core Responsibilities

• Participant Engagement & Pre-Screening
• Documentation & Regulatory Compliance
• Scheduling & Cross-Functional Coordination
• Risk Identification & Escalation
• Performance Management

Functional Tracks

Enrollment Specialists may be assigned to one of two primary functional tracks based on operational needs:

Track 1: Participant Engagement & Pre-Screening Focus
Responsible for medical pre-screening, eligibility determination, and enrollment conversion.

Track 2: Scheduling & Coordination Focus
Responsible for visit scheduling, participant reminders, and cross-functional coordination.

All Enrollment Specialists are cross-trained and may support both tracks as business needs evolve.

Duties and Responsibilities

1. Participant Engagement & Pre-Screening

• Initiate timely outreach to new leads in accordance with SOPs and Work Instructions.
• Conduct protocol-driven medical pre-screening using approved scripts while maintaining compliance.
• Apply strong protocol knowledge to ensure accurate eligibility determination and appropriate referrals.
• Maintain high screening accuracy by minimizing both false positives and missed qualified candidates.
• Perform multiple, well-documented contact attempts across varied times of day.
• Clearly communicate study details, eligibility criteria, and next steps in a professional and empathetic manner.

2. Documentation & Regulatory Compliance

• Accurately document all participant interactions, screening responses, eligibility outcomes, and next steps.
• Ensure full compliance with PII/PHI handling in accordance with HIPAA, GCP, company SOPs, and study requirements.
• Stay current with protocol updates, informed consent requirements, and regulatory standards.

3. Scheduling & Cross-Functional Coordination

• Schedule eligible participants for study visits in alignment with protocol requirements and site availability.
• Coordinate with site staff and internal teams to confirm logistics and prevent delays.
• Provide complete and accurate handoffs to Clinical Success Specialists and site teams.
• Send appointment reminders via approved communication channels when assigned.

4. Risk Identification & Escalation

• Identify and escalate participant safety concerns (e.g., uncontrolled medical conditions, suicidal ideation) per SOPs.
• Ensure timely notification of appropriate clinical personnel for urgent issues.
• Identify recurring eligibility or screening trends and share insights to improve processes and reduce screen failures.

5. Performance Expectations

• Adhere to defined outreach timelines and operational standards.
• Maintain productivity levels aligned with workload demands and role assignment.
• Balance call volume with screening quality and accuracy.
• Ensure complete and accurate documentation for all interactions.
• Meet enrollment and productivity targets based on study and departmental KPIs.
• Adapt performance based on assigned functional track and operational needs.

Qualifications

1. Education & Experience

• Minimum 2–3 years of experience in clinical research recruitment, patient pre-screening, study coordination, or high-volume healthcare call center environments.
• Experience conducting structured medical pre-screenings or reviewing health histories against defined eligibility criteria.
• Proven ability to manage productivity metrics in a performance-driven environment (e.g., call volume, conversion rates, enrollment targets).

2. Clinical Research Knowledge

• Working knowledge of clinical trial processes, including protocol adherence, informed consent workflows, and IRB-regulated activities.
• Understanding of Good Clinical Practice (GCP) principles.
• Ability to interpret eligibility criteria and accurately apply inclusion/exclusion requirements.

3. Communication & Interpersonal Skills

• Strong verbal communication skills with the ability to explain complex medical information in clear, participant-friendly language.
• Ability to build rapport quickly while maintaining structured screening flow.
• Professional and composed when handling sensitive health discussions and objections.

4. Work Style & Performance Orientation

• Highly detail-oriented with strong documentation accuracy in regulated environments.
• Able to work within strict timelines while maintaining quality and productivity standards.
• Strong time management skills, balancing outreach, screening, and scheduling tasks.
• Capable of working independently while adhering to SOPs and Work Instructions.
• Thrives in fast-paced, evolving environments with shifting priorities and processes.
• Demonstrates adaptability, sound judgment, and initiative when workflows are unclear or evolving.
• Proactively contributes to process improvement while maintaining performance expectations.
• Maintains professionalism, accountability, and composure in ambiguous or changing conditions.

Other Duties as Assigned

The responsibilities listed above represent the primary functions of the role; additional duties may be assigned based on operational or study needs.

All Enrollment Specialists are expected to:

• Adapt to changing priorities, lead volume fluctuations, and operational demands.
• Support cross-functional initiatives that improve enrollment efficiency and participant experience.
• Maintain professionalism in all interactions with participants, site staff, and internal teams.
• Contribute to ongoing workflow and process improvements.
• Uphold company values, regulatory standards, and performance expectations.

Note: Duties and responsibilities may evolve based on business and study requirements.

Shift: Night Shift - 8PM - 5AM