Pre-Screening Manager

ALLIANCE CLINICAL LLC•Las Vegas, NV

2d•Onsite

About The Position

The Pre-Screening Manager is responsible for coordinating and overseeing site screening schedules, managing pre-screening operations, and overseeing patient eligibility assessments. The role involves reviewing protocols, training staff, maintaining knowledge of research study guidelines and clinical trial protocols, explaining study procedures to potential participants, performing screening exams, and maintaining detailed records. The manager will also oversee site screening schedules, coordinate workflow efficiency, track pending items, manage and prioritize site activities to meet goals, communicate risks and barriers, follow standardized processes, resolve QA findings, and support the development of the HCP network.

Requirements

Associate’s degree in healthcare or related field is required.
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.

Nice To Haves

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.
Certified Phlebotomy Technician (CPT) certification is preferred.
Certified Medical Assistant or related certification is preferred.

Responsibilities

Review and break down protocols and informed consents for patient eligibility and recruitment.
Train and support staff managing prescreen 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 answer 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 any 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 coordinate 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.