Clinical Research Coordinator-Full-time-Onsite

Description

Welcome to Holy Name, a medical center where innovation is not just a goal — it's a commitment. Here, medical excellence thrives, allowing hope to reign supreme and leaving no room for fear. At our hospital, every patient is cared for with undivided attention — because healing every soul is our sole focus.

Holy Name is New Jersey's only independent Catholic health system, comprising a 361-bed acute care hospital, a renowned cancer center, a state-of-the-art fitness center, a residential hospice, a prestigious nursing school, and an extensive physician network. Healing at Holy Name goes beyond medicine and technology – it is infused with faith, conviction, compassion, and a commitment to educating the next generation of healthcare professionals through a variety of residency and educational programs. Our mission to provide care for the body, mind, and soul spans education, prevention, diagnosis, treatment, rehabilitation, and overall wellness. This is at the core of who we are and what we do, and we've done it this way across generations, every single day, for nearly 100 years. Every innovation, medical breakthrough, and groundbreaking treatment is powered by some of the best minds in medicine, ensuring nothing is left on the table or the road to recovery.


A Brief Overview

Working under the direction of the Institute for Clinical Research (ICR) and the Principal Investigator (PI), the Clinical Research Coordinator is responsible for the end-to-end coordination and execution of clinical research studies conducted through the ICR. This role serves as the primary operational lead for assigned trials, ensuring studies are conducted in compliance with protocol requirements, Good Clinical Practice (GCP), and institutional and regulatory standards. The Coordinator oversees study activities from start-up through close-out, including regulatory submissions, participant screening and enrollment, study visit coordination, data and document management, and ongoing communication with investigators, sponsors, IRBs, and internal clinical teams. The role requires independent judgment, strong organizational skills, and the ability to manage multiple studies while maintaining data integrity, participant safety, and study timelines.


What you will do

• Human Subjects Protection & Regulatory Compliance:
• Protect the rights, safety, and welfare of human research participants in accordance with ethical principles, regulatory requirements, and institutional policies.
• Maintain working knowledge of regulatory, institutional, sponsor, and protocol requirements applicable to assigned studies.
• Understanding the regulatory, institutional, sponsor and protocol requirements for the study
• Completing IRB required human subjects protection training (in addition to any other sponsor required training)
• Complying with all IRB decisions, conditions and requirements
• Capturing and reporting adverse events and protocol violations to the study PI, the IRB and the study sponsor
• Ensuring that PHI will not be reused or disclosed to any parties other than those described in the IRB-approved protocol, except as required by law
• Making sure that all studies have current IRB approvals before any study is initiated, continued beyond the period of current approval (usually 1 or 3 years) or modified in any way
• Study Feasibility & Start-Up:
• Evaluate new protocols for feasibility in collaboration with the Principal Investigator, including assessment of patient population, enrollment potential, and operational requirements.
• Review study protocols and supporting materials (e.g., Investigator’s Brochure, consent forms, data collection tools) to identify safety concerns, workflow challenges, and practical considerations.
• Assess logistical needs and resource availability, including staffing, space, ancillary services, and departmental support.
• Prepare and submit regulatory documents to the IRB and manage all start-up-related approvals.
• Organize and maintain regulatory and study files, ensuring readiness for study initiation and ongoing oversight.
• Prepare the site for study conduct, including participation in investigator meetings and coordination of sponsor site initiation visits.
• Create, adapt, or review study-specific source documents as needed.
• Study Operations & Oversight:
• Train and support all individuals involved in study conduct, including investigators, study staff, and ancillary departments.
• Collaborate with internal departments (e.g., laboratory, pharmacy, radiology) to ensure protocol-required procedures are executed correctly.
• Participate in sponsor, institutional, and regulatory audits, including for-cause and routine monitoring activities.
• Maintain audit-ready study documentation and respond to audit findings as needed.
• Informed Consent Process:
• Participate in and support the informed consent process in accordance with the IRB-approved protocol.
• Work with the sponsor and/or IRB on consent language revisions, including coordination of translated consent forms when required.
• Conduct the informed consent discussion with potential participants or their legally authorized representatives when delegated
• Implement amended consent forms promptly and ensure re-consent occurs when required.
• Ensure informed consent is an ongoing process throughout the duration of the study.

Education Qualifications

• Bachelor's Degree or equivalent clinical research experience required and

Experience Qualifications

• Minimum of 2 years of clinical research experience required
• 5+ years of experience preferred

Knowledge, Skills, and Abilities

• Analytical and problem-solving skills – Ability to interpret clinical trial protocols, eligibility criteria, and study data; identify discrepancies, trends, or risks; and escalate issues appropriately.
• High attention to detail and data accuracy – Demonstrated precision in regulatory documentation, source documentation, and data entry, with the ability to maintain audit-ready study files.
• Strong organizational and time-management skills – Proven ability to manage multiple studies, competing deadlines, and study visits while maintaining protocol compliance and data integrity.
• Effective collaboration and teamwork – Ability to work productively with investigators, research nurses, sponsors, monitors, IRBs, and ancillary clinical departments to support study execution.
• Professional communication skills (verbal and written) – Clear, accurate, and timely communication with patients, physicians, sponsors, and regulatory bodies, including preparation of study correspondence and documentation.
• Patient-facing skills – Comfort interacting with research participants to explain study procedures, support informed consent, and ensure a positive, ethical participant experience.
• Clinical and healthcare environment fluency – Ability to work effectively within a hospital or clinical research setting and communicate appropriately with physicians and multidisciplinary healthcare teams.
• Computer and systems proficiency – Experience using clinical research systems and tools (e.g., EDC, CTMS, eRegulatory platforms, Microsoft Office) and ability to learn new systems quickly.
• Judgment and professionalism – Ability to exercise sound judgment, maintain confidentiality, and uphold ethical and regulatory standards in all aspects of research conduct.

Licenses and Certifications

• GRP certification upon hire preferred
• CCRP - Certified Clinical Research Professional preferred or
• CCRC - Certified Clinical Research Coordinator preferred

At Holy Name, we believe in rewarding every team member with more than a paycheck—we invest in your future and well-being. Full-time and part-time employees have access to a comprehensive benefits package designed to support your health, financial security, and quality of life. We offer low-cost medical coverage with generous employer contributions, dental and vision plans, discounted prescriptions, and access to on-site child care. Additional benefits include 401(k) matching, tuition reimbursement, paid time off, flexible spending accounts, legal and voluntary coverage options, life insurance, and free on-site parking. If you are hired at Holy Name, your final base compensation will be determined based on factors such as employment status (Full/Part-Time or Per Diem) skills, education, and/or experience. In addition to those factors – we believe in the importance of pay equity and consider any internal equity of our current team members as a part of any final offer. Pay Range: $50,003.20 - $67,496.00



Holy Name is a mission-driven facility whose quality standards and philosophy are rooted in the principles of its founders, the Sisters of St. Joseph of Peace. Those principles are exercised daily by the Medical Center's dedicated and talented staff members. Holy Name is an Equal Opportunity Employer.