Pre-Screen Coordinator II

ALLIANCE CLINICAL LLC; Lewisville (TX); On-site; USD 42,000 - 60,000; Full time

Job summary

Alliance Clinical Network in Lewisville, TX is seeking a Pre-Screen Coordinator II to coordinate and oversee site screening schedules, manage pre-screening operations, and assess participant eligibility for multiple clinical studies.

You will review protocols and consent documents, conduct pre-screen visits, maintain records, and ensure compliance with FDA regulations and GCP. Strong organizational and communication skills are essential.

Qualifications

• 2 years of experience running research protocols.
• 2 years of experience with FDA regulations and GCP.
• Strong organizational and interpersonal skills.
• Excellent verbal and written communication skills.

Responsibilities

• Review and break down protocols and informed consent documents for patient eligibility and recruitment.
• Conduct pre-screen visits and assessments.
• Explain the study procedures and risks, benefits, and follow-up to participants.
• Create and maintain detailed records of candidate information.
• Oversee site screening schedules and ensure compliance and audit readiness.

Skills

FDA regulations

GCP

Analytical reasoning

Attention to detail

Communication skills

Multitasking

Education

Associate’s degree in healthcare or related field

Bachelor’s degree in biology/life sciences/public health

Master’s degree (plus)

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Pre-Screen Coordinator II

FullTime Alliance Clinical Lewisville, Lewisville, TX, US

7 days ago Requisition ID: 1340

Summary:

The Pre-Screen Coordinator II is responsible for coordinating and overseeing site screening schedules, managing pre-screening operations, and overseeing patient eligibility assessments.

Essential Duties and Responsibilities:

• Review and break down protocols and informed consent documents for patient eligibility and recruitment.
• Conduct pre-screen visits and assessments.
• Maintain a thorough understanding of research study guidelines, including both inclusion and exclusion criteria.
• Demonstrate comprehensive knowledge of clinical trial protocols.
• Explain the study procedures and answers questions to ensure potential participants understand the study requirements and processes.
• Explain the study’s purpose, procedures, risks, benefits, compensation, and follow-up care to potential participants prior to their entry into the study.
• Perform screening exams to determine participants’ health status prior to their participation in studies involving new medications or procedures.
• Create and maintain detailed records of call logs and study candidates, including names, addresses, phone numbers, birth dates, and other identifying information.
• Collect blood samples and analyze test results from candidates to determine study eligibility and identify any physical impairments that could interfere with their participation in the study.
• Oversee site screening schedules, ensuring all activities adhere to compliance requirements.
• Coordinate workflow efficiency and performance during pre-screen visits.
• Track and follow up on pending items (e.g., medical records, labs, eligibility confirmations) to support screening decisions.
• Actively manage and prioritize site activities to attempt to meet assigned pre-screening, screening, and randomization goals in alignment with established targets.
• Proactively communicate risks, barriers, or delays that may impact goal achievement, and collaborate with leadership to resolve them.
• Follow standardized pre-screening processes and workflows to ensure consistency, quality, and compliance across all visits.
• Resolve QA findings promptly and maintain continuous compliance and audit readiness.
• Alert the site’s Investigator to any clinically significant patient findings and coordinates investigator assessment during the pre-screen visit.
• Support development of the HCP (Healthcare Provider) network by identifying and building relationships with appropriate providers to drive referrals, conduct chart reviews, and maintain partnerships.
• Perform other duties as assigned.

Qualifications:

• Associate’s degree in healthcare or a related field is preferred.
• Bachelor’s degree in biology, life sciences, public health, or a related field is preferred. A master’s degree is a plus.
• 2 years of experience in running research protocols is preferred.
• 2 years of experience with FDA regulations and GCP is preferred.
• Proven track record of analytic reasoning and problem-solving skills.
• Strong attention to detail with excellent organizational and interpersonal skills.
• Excellent verbal and written communication skills are required.
• A proven ability to multitask in a rapidly changing environment.

ACN does not provide visa sponsorship for this role. Candidates who will require immigration or visa sponsorship at any time now or in the future (including, but not limited to, H‑1B, TN, or STEM OPT training plans) are not eligible for this role.

About the Company:

At Alliance Clinical Network, our mission is to advance medical research by enrolling diverse populations in high-quality clinical trials. We are committed to maintaining the highest standards of integrity and excellence, and to ensuring that every participant receives respectful and compassionate care. We strive to build a tightly knit, supportive and collaborative environment where our team members can thrive and make meaningful contributions to human health.