Clinical Operations Coordinator

Company Description: Clinical Research Philadelphia (CRP) is a leading clinical research site that has served the Philadelphia community for over 25 years, with a strong focus on advancing patient care through high-quality clinical trials. The organization has successfully completed more than 300 studies across a wide range of therapeutic areas, providing diverse opportunities for research professionals. The organization operates research sites in both Philadelphia and Pennington. CRP’s dedicated research team brings over 80 years of combined experience, ensuring robust protocol adherence and participant safety. The site operates a fully electronic Clinical Trial Management System with remote monitoring capabilities, supporting efficient and compliant trial operations. Its state-of-the-art facility includes multiple exam rooms, secure drug storage, and dedicated monitor offices, enabling a professional and organized research environment.

Role Description: The Clinical Operations Coordinator supports the planning, execution, and oversight of clinical research studies to ensure compliance with protocol requirements, Good Clinical Practice (GCP), regulatory guidelines, and sponsor expectations. This role serves as a key liaison between investigators, study teams, sponsors, CROs, vendors, and regulatory agencies while coordinating operational, regulatory, and administrative activities throughout the study lifecycle.

Essential Responsibilities

• Coordinate clinical trial activities from study start-up through close-out.
• Support site initiation, activation, enrollment, maintenance, and study completion activities.
• Maintain essential study documentation, regulatory files, and trial master records.
• Assist with preparation and submission of regulatory documents to Institutional Review Boards (IRBs), Ethics Committees (ECs), sponsors, and regulatory authorities.
• Track study milestones, timelines, deliverables, and action items.
• Review study documentation for completeness, accuracy, and compliance.
• Support subject recruitment, screening, enrollment, retention, and follow-up activities.
• Coordinate study visits and ensure protocol-required procedures are completed according to study requirements.
• Assist with review and reconciliation of source documentation, study records, laboratory data, and electronic data capture systems.
• Monitor study progress and identify operational risks, protocol deviations, and compliance concerns.
• Collaborate with investigators and study staff to ensure timely resolution of data queries and outstanding issues.
• Maintain communication with sponsors, CROs, vendors, and internal stakeholders.
• Support study training activities and ensure personnel maintain required certifications and training records.
• Assist with investigational product accountability, laboratory logistics, and vendor coordination as applicable.
• Prepare study reports, trackers, metrics, and operational updates.
• Participate in monitoring visits, audits, inspections, and follow-up activities.
• Ensure adherence to applicable regulations, ICH-GCP guidelines, SOPs, and study protocols.

Additional Responsibilities

• Review and reconcile medical records against protocol inclusion/exclusion criteria and identify potential eligibility concerns prior to participant visits.
• Conduct pre-screening and eligibility assessments using source documentation, laboratory data, medical history, and sponsor requirements.
• Build and maintain electronic source (eSource) documents, study visit templates, workflows, and protocol-specific forms within clinical research platforms.
• Configure and maintain study databases and clinical trial management systems, including visit schedules, procedures, questionnaires, portal links, and study-specific workflows.
• Review laboratory results, imaging reports, and external medical records for protocol-required data collection and documentation.
• Develop study-specific screening tools, eligibility trackers, flowcharts, process maps, and operational guides.
• Support remote study management activities, including document review, visit preparation, post-visit quality review, and compliance oversight.
• Review subject records to ensure required documentation, signatures, annotations, and investigator oversight are completed.
• Provide protocol-specific operational support and guidance to site personnel.

Qualifications

Required Qualifications

• Minimum 3 years of Clinical Research Coordinator (CRC) experience in a clinical research site, academic research center, CRO, or related healthcare research environment.
• Demonstrated experience supporting multiple clinical trials across various phases and therapeutic areas.
• Strong understanding of clinical research regulations, ICH-GCP guidelines, informed consent requirements, protocol compliance, source documentation, and participant safety.
• Experience reviewing medical records, laboratory reports, and source documentation for study eligibility, protocol compliance, and data quality.
• Experience with study start-up activities, regulatory documentation, IRB submissions, essential document maintenance, and investigator site files.
• Experience performing quality control (QC) reviews and identifying documentation, data, and compliance issues.
• Experience working with Electronic Data Capture (EDC), eSource, CTMS, CRIO, or similar clinical research systems.
• Strong communication skills, including clear written and verbal interaction with patients, investigators, sponsors, CROs, vendors, and internal teams.
• Excellent organizational, project coordination, and time management skills with the ability to manage multiple studies, priorities, and deadlines simultaneously.
• Strong attention to detail and problem-solving abilities with a focus on data accuracy, compliance, and operational efficiency.
• Ability to work independently and collaboratively in a remote or hybrid environment while maintaining accountability and professionalism.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint) and clinical research technology platforms.

Preferred Qualifications

• Bachelor's degree in Life Sciences, Healthcare Administration, Nursing, Public Health, Clinical Research, or a related field.
• Experience with study start-up, site activation, and regulatory submissions.
• Experience building or maintaining eSource templates, study workflows, visit guides, screening tools, or study databases.
• Experience reviewing eligibility criteria and performing participant pre-screening activities.
• Experience supporting dermatology, rheumatology, gastroenterology, endocrinology, cardiology, or other specialty clinical research programs.
• Experience working directly with sponsors and CROs during monitoring visits, audits, inspections, and query resolution activities.
• Experience supporting remote clinical operations and centralized study management functions.