What are the responsibilities and job description for the Pre-Screen Operations & Compliance Manager position at ALLIANCE CLINICAL LLC?
Location: This position is remote
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.
Summary:
The Pre-Screen Operations & Compliance Manager (POCM), under the direction and ongoing supervision of the Director of Pre-Screen Operations (DPO), supports in the daily functions of clinical research prescreen operations and quality. Responsibilities include overseeing all prescreen visit data and procedural compliance according to standard operating procedures (SOPs). Maintains all eligibility data for reporting and compliance purposes. Configures and designs all prescreen visits across the organization within CRIO, cross-referencing all clinical trial protocols to ensure conformity with eligibility requirements. Conducts site audits to ensure all PSMs adhere to prescreen operational requirements. Facilitates departmental training procedures and directs all quality assurance and compliance activities, supporting the DPO.
Essential Duties and Responsibilities:
- Support the DPO as requested to facilitate business and research prescreen needs.
- Communicate effectively and courteously with employees regarding prescreen visit objectives and ongoing visit instructions.
- Manage patient prequalification questionnaires and configuration designs in CRIO.
- Demonstrate comprehensive knowledge of clinical trial protocols.
- Analyze key factors of inclusion and exclusion of study protocols for eligibility compliance.
- Facilitate prescreen operations quality and compliance training as requested.
- Manage all start-up activities and designs contributing to prescreen operations.
- Meet all deadlines required by the DPO relating to prescreen operations.
- Evaluate all prohibited and allowed concomitant medications per study criteria for eligibility compliance for all study visits and conversions.
- Verify the accuracy of data collected by the prescreen department.
- Perform administrative tasks, including automating and generating data, as required.
- Manage all upcoming study protocol questionnaires and ensure all required deadlines are met.
- Report all prescreen data and eligibility quality metrics.
- Manage all prescreen CRIO visit configurations, amendments, and prequalification questionnaires.
- Perform other duties as assigned.
Qualifications:
- Minimum of 1 year of experience in healthcare preferred but not required.
- Minimum of 1 year of experience in quality assurance required.
- Exceptional attention to detail and organization.
- Must possess excellent verbal and written communication skills.
- Excellent customer service skills when working with internal and external stakeholders.
- A proven ability to multitask in a rapidly changing environment.
Certificates, Licenses, and Registrations:
- Maintain GCP certification and other job-specific certifications as required.
Travel Required:
This position requires up to 50% travel to clinical sites and partner locations to support prescreen managers, conduct audits, maintain quality and compliance, launch new programs, and maintain strong on-site relationships.
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.
Benefits: Medical, Dental, Vision, 401k, PTO and more!