Clinical Research Compliance Specialist

Alliance Clinical Network advances medical research through high-quality clinical trials and a commitment to research integrity and participant care. The Clinical Research Compliance Specialist supports clinical studies by monitoring protocol and regulatory compliance, reviewing data and essential documents, conducting quality control activities, and developing risk-monitoring plans.

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

Preferred

a bachelor's degree preferred

Bachelor's Degree

Company

Clinical research site network for clinical trials

Southlake, Texas, USA

https://excelresearchclinic.com/

201-500 employees

Qualifications

An associate's degree in healthcare or a related field

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

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

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.

Required skills

Clinical Research, Clinical Research Compliance, Clinical Practice (GCP), Standard Operating Procedures (SOPs), Microsoft Office Suite, Adobe Acrobat, Clinical Trial Terminology, Risk Monitoring Plans

Preferred skills

a bachelor's degree preferred, Southlake, Texas, USA, https://excelresearchclinic.com, Growth Stage, Leadership Team, Jason Cunio, Chief Financial Officer, Janice Shock, MBA, PHR, Chief Human Resources Officer, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

2+ years