Clinical Research Compliance Specialist

Summary:

The Clinical Research Compliance Specialist supports clinical research studies by monitoring protocol and regulatory compliance, reviewing research data for accuracy, managing documentation and milestones, auditing essential documents, preparing internal monitoring reports, and developing risk monitoring plans and study-related documents.

Essential Duties and Responsibilities:

• Conduct SOP, GCP, and compliance training for coordinators at the site.
• Ensure sites adhere to ACN's policies and procedures.
• Perform on-site and remote quality control (QC) reviews to evaluate compliance and ensure the protection of human subjects and data integrity.
• Ensure valid findings from QC reviews are managed effectively and in accordance with established procedures, and escalate significant findings to ACN leadership as they are identified.
• Coach and support CRCs and PIs on a continuous basis based on QC findings.
• Monitor protocol and regulatory compliance for clinical research studies with low- to high-risk research designs across multiple treatment areas.
• Review research data from source documentation for accuracy, completeness, and timeliness.
• Collaborate with the offshore compliance team and the on-site study team to effectively address critical findings.
• Strictly adhere to confidentiality and compliance standards.
• Collect, review, maintain, and audit essential documents.
• Assist in developing documents and implementing study-specific risk-monitoring plans.
• Support ongoing communication with study teams regarding trial qualification, initiation, monitoring, remote monitoring, and close-out activities.
• Serve as the main point of contact for compliance audits and interim monitoring visits.
• Read and comprehend new and amended research protocols.
• Meet assigned targets, goals, and completion deadlines.
• Utilize analytical, problem-solving, and critical thinking skills.
• Communicate clearly and effectively with various stakeholders, tailoring messages to the appropriate audience and organizational level.
• Collaborate effectively across functions to identify solutions aligned with organizational and functional priorities.
• Perform other duties as assigned.

Qualifications:

• An associate's degree in healthcare or a related field; a bachelor's degree preferred.
• Minimum of 2 years of clinical research experience as a Clinical Research Coordinator (CRC) or 1 year of experience as a Clinical Research Associate (CRA) is required.
• Proficient in Microsoft Office Suite applications and Adobe Acrobat.
• Working knowledge of medical and/or clinical trial terminology.
• Working knowledge of relevant scientific fields.
• Strong attention to detail.
• Ability to prioritize competing demands.
• Excellent verbal and written communication skills.
• A proven ability to multitask in a rapidly changing environment.
• Demonstrates adaptability and sound judgment when priorities shift, using available information to deliver results.

Work Schedule

Monday - Thursday: Regular Business Hours

Friday - Half Day

*Some travel between Rochester & Buffalo sites required.*

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.

Monday - Thursday: Regular Business Hours
Friday - Half Day
*Some travel between Rochester & Buffalo sites required.*