Clinical Trial Assistant

Job Description

Job Description

Clinical Trial Visit Flow Manager

Internal Title: Visit Expediter / Agilizador de Visitas

Position Summary

The Clinical Trial Visit Flow Manager is responsible for ensuring that every clinical-trial participant moves efficiently and safely from arrival through completion of all required visit procedures and discharge.

This person acts as the operational control tower for patient visits. The role does not replace the CRC, investigator, laboratory staff or clinical team. Its purpose is to coordinate them, identify delays immediately and prevent participants from waiting unnecessarily.

Special priority must be given to fasting participants so that required fasting laboratory specimens, pharmacokinetic samples and other time-sensitive procedures are completed as early as permitted by the protocol.

Primary Objective

Reduce the total time between:

Patient arrival → check-in → protocol verification → laboratory procedures → clinical assessments → completion of documentation → patient compensation and discharge.

Key Responsibilities

Before the Visit

• Review the next day’s schedule in Salesforce.
• Confirm the visit type and protocol-required procedures.
• Identify fasting visits, timed laboratory collections, PK visits, infusions and other time-sensitive procedures.
• Confirm that laboratory kits, requisitions, supplies, examination rooms and assigned staff are available.
• Identify missing orders, records, questionnaires or authorizations before the participant arrives.
• Coordinate transportation status, including Uber arrangements when applicable.
• Flag scheduling conflicts, excessive patient volume or insufficient staffing.

Upon Patient Arrival

• Record or confirm the participant’s arrival time in Salesforce.
• Verify that the correct study team has been notified.
• Prioritize fasting and time-sensitive participants.
• Confirm that the participant is directed to the correct study area.
• Monitor how long the participant waits before the first required procedure begins.

During the Visit

• Follow the participant’s progress through each required visit stage.
• Confirm completion of required operational steps without making clinical decisions.
• Notify the responsible CRC when a visit stops progressing.
• Escalate laboratory, pharmacy, investigator, room, equipment or documentation delays.
• Coordinate communication among reception, CRCs, laboratory personnel, NPs, Sub-Investigators, investigators, data-entry staff and the compensation team.
• Ensure that fasting participants are offered food and beverages as soon as fasting procedures are completed and the protocol permits.
• Keep participants informed when unavoidable delays occur.
• Prevent participants from being forgotten between departments.

Before Discharge

• Confirm with the assigned CRC that all scheduled procedures have been completed or appropriately documented as pending.
• Confirm that required follow-up appointments have been scheduled.
• Ensure transportation and participant compensation are addressed.
• Record the participant’s departure time.
• Document the reason for significant delays, incomplete visits or early departures.

Priority Workflow for Fasting Visits

1. Patient arrival and identity confirmation.
2. Immediate notification to the assigned CRC and laboratory team.
3. Confirmation that fasting requirements were followed.
4. Rapid completion of protocol-required fasting laboratory collections.
5. Completion of other fasting-dependent procedures.
6. Release from fasting by authorized clinical personnel.
7. Provision of breakfast, coffee, water or an appropriate meal.
8. Completion of remaining assessments.
9. Compensation, transportation coordination and discharge.

Escalation Standards

The Visit Flow Manager must escalate:

• Any fasting participant waiting more than 15 minutes for laboratory processing.
• Any participant waiting more than 20 minutes without an active visit step.
• Missing laboratory kits, supplies, staff, rooms or protocol materials.
• Delayed timed or PK specimens.
• A participant who wants to leave before completing the visit.
• Any medical complaint immediately to qualified clinical personnel.
• Potential protocol deviations to the assigned CRC and investigator.
• Any visit predicted to exceed its planned completion time.

Decision Boundaries

Salesforce Responsibilities

• Maintain a real-time patient-flow dashboard.
• Track each participant’s current visit stage.
• Record arrival, laboratory start, laboratory completion, investigator assessment, visit completion and departure times.
• Generate alerts when a participant exceeds the expected time at any stage.
• Maintain a visible fasting-priority queue.
• Document operational delay reasons.
• Produce daily and weekly performance reports.
• Identify recurring bottlenecks by study, department, employee and visit type.

Performance Indicators

The position will be evaluated using:

• Arrival-to-first-procedure time.
• Arrival-to-fasting-laboratory-collection time.
• Total visit duration by protocol and visit type.
• Percentage of visits completed within the planned time.
• Number of participants waiting more than 20 minutes without an active visit step.
• Number of participants leaving before visit completion.
• Percentage of visits with complete timestamps.
• Frequency and causes of delayed or missed procedures.
• Participant satisfaction.
• Reduction in overtime, duplicated work and preventable protocol deviations.

Qualifications

• Experience in clinical research, medical-office operations, patient coordination or healthcare scheduling.
• Strong understanding of clinical-trial visit workflows.
• Ability to coordinate several participants and departments simultaneously.
• Excellent communication, organization and problem-solving skills.
• Comfortable using Salesforce, dashboards and electronic scheduling systems.
• Bilingual English and Spanish strongly preferred.
• GCP and HIPAA training required before independently performing the role.
• Medical license is not required because the position does not make clinical decisions.

Work Arrangement

This position may include onsite and remote personnel:

• Onsite Visit Flow Manager: Directly coordinates patient movement, staff readiness, laboratory priority and physical bottlenecks.
• Remote Flow Coordinator: Monitors Salesforce, communicates with departments, identifies missing steps, tracks time thresholds and prepares performance reports.

At high patient volume, one onsite Visit Flow Manager should not control the entire center alone. Each operating area or group of approximately 40–60 daily visits should have a designated Flow Coordinator reporting to a central Patient Flow Operations Manager.

Reporting Structure

The Clinical Trial Visit Flow Manager reports to the Director of Clinical Operations and works closely with:

• Principal Investigators
• NPs and Sub-Investigators
• Lead CRCs and CRCs
• Laboratory personnel
• Recruitment and scheduling teams
• Transportation coordinators
• Participant compensation team
• Food-service team
• Remote data-entry and quality teams
• Salesforce administrators

Definition of Success

The position is successful when participants move through required procedures safely, fasting time is minimized, staff know what must happen next, delays are visible in real time, and patients leave as quickly as the protocol and appropriate clinical care allow.