Clinical Research Monitor

Job Description

Job Description

Job Title: Clinical Research Monitor

Job Description

This fully remote Clinical Research Monitor role focuses on supporting IND‑regulated clinical trials within an academic research environment. The position centers on risk-based monitoring, Trial Master File (TMF) management, and ensuring adherence to FDA regulations, IND/IDE requirements, and Good Clinical Practice (GCP) guidelines. You will work autonomously while collaborating closely with research, regulatory, and compliance leaders to support high-profile breast imaging and interventional breast procedure studies. This newly created role offers significant visibility, strong potential for extension beyond the initial contract term, and the opportunity to gain valuable experience in IND-regulated clinical research.

Responsibilities

• Perform independent clinical research monitoring activities for IND-regulated studies, ensuring compliance with FDA regulations, GCP guidelines, and institutional policies.
• Apply risk-based monitoring methodologies to plan, prioritize, and conduct monitoring activities efficiently and effectively across assigned studies.
• Create, implement, and maintain study-specific monitoring plans that align with protocol requirements, regulatory expectations, and risk-based strategies.
• Manage and oversee Trial Master File (TMF) documentation, ensuring completeness, accuracy, and timely filing of essential documents.
• Conduct detailed chart reviews, data reviews, and source data verification to ensure data integrity, protocol adherence, and accurate data entry.
• Prepare clear, comprehensive monitoring reports and follow-up documentation that summarize findings, identify issues, and recommend corrective actions.
• Maintain regulatory files and study documentation in accordance with applicable regulations, institutional standards, and sponsor requirements.
• Collaborate closely with research, regulatory, and compliance teams to support IND oversight and address monitoring, documentation, and regulatory needs.
• Participate in screening and data management activities as needed to support study conduct and ensure high-quality data collection.
• Support the conduct of high-quality interventional breast procedures research, including studies involving stereotactic, ultrasound-guided, and MRI-guided biopsies.
• Communicate proactively with study teams regarding site performance, protocol deviations, data queries, and required corrective or preventive actions.
• Work with minimal supervision, managing your own workload, timelines, and priorities across multiple concurrent studies.
• Contribute to continuous improvement of monitoring processes, risk-based monitoring approaches, and documentation practices within the research program.
• Engage with key stakeholders during occasional onsite visits for walkthroughs, equipment assessments, or study-specific needs, as required.

Essential Skills

• Bachelor's degree in a scientific discipline or a Registered Nurse (RN) credential combined with clinical research experience.
• 2–4+ years of clinical research monitoring experience, including independent execution of monitoring activities.
• Demonstrated experience with IND-regulated clinical research and a strong understanding of IND/IDE regulations and processes.
• Hands-on experience with risk-based monitoring methodologies in a clinical research setting.
• Proven experience creating and implementing monitoring plans for clinical trials.
• Trial Master File (TMF) management experience, including organization and maintenance of essential documents.
• Strong understanding of FDA regulations and Good Clinical Practice (GCP) guidelines.
• Experience preparing detailed monitoring reports and associated documentation.
• Experience maintaining regulatory files and study documentation in compliance with applicable standards.
• Ability to work with minimal supervision and manage multiple priorities independently.
• Strong organizational skills with attention to detail and accuracy in documentation.
• Effective written and verbal communication skills for interaction with research, regulatory, and compliance stakeholders.
• Clinical research experience in addition to RN credentials for candidates with a nursing background.

Additional Skills & Qualifications

• Experience within an academic medical center or research institution environment.
• background in clinical research data management, including data entry, data review, and query resolution.
• Familiarity with chart review and screening processes in clinical research.
• Knowledge of FDA processes related to IND oversight and monitoring.
• Experience collaborating with multidisciplinary teams, including regulatory specialists, compliance professionals, and clinical imaging or nuclear medicine teams.
• Ability to work autonomously while contributing to high-profile research initiatives.
• Interest in or prior exposure to breast imaging and interventional breast procedure research.
• Motivation to contribute to early and precise detection and diagnosis of breast diseases through high-quality clinical research.

Work Environment

The role is structured as a 100% remote position, primarily due to limited onsite office space. Day-to-day responsibilities are performed remotely, with digital tools and systems used to manage monitoring activities, Trial Master File documentation, and regulatory files. Candidates can expect initial in-person introductions with key stakeholders, followed by occasional, rare onsite visits for walkthroughs, equipment assessments, or study-specific needs. The position operates within an academic medical and research environment focused on advanced breast imaging technologies and high-quality interventional breast procedures, including stereotactic, ultrasound-guided, and MRI-guided biopsies. Collaboration occurs regularly with research, regulatory, compliance, and nuclear medicine teams, and the role offers flexibility, autonomy, and the opportunity to support complex, IND-regulated clinical studies. No specific dress code is prescribed for remote work, while standard professional attire is expected during any in-person meetings or onsite visits.

This is a Contract position based out of Philadelphia, PA.

The pay range for this position is $40.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a hybrid position in Philadelphia,PA.

This position is anticipated to close on Sep 18, 2026.

About Actalent

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The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.