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Clinical Operations

• Develop and maintain project plans, timelines, budgets, and risk management strategies for assigned clinical trials
• Manage day-to-day trial operations across start-up, enrollment, monitoring, and close-out
• Serve as liaison between sponsors, CROs, investigators, IRBs/ECs, and internal stakeholders
• Oversee site selection, activation, and performance
• Monitor trial budgets, forecast expenditures, and manage vendor/CRO contracts and deliverables
• Ensure compliance with ICH-GCP, FDA/EMA regulations, and applicable local laws
• Track and report enrollment, data quality, and milestone progress
• Identify, assess, and mitigate risks and issues affecting timelines, budget, or quality
• Coordinate with Data Management, Biostatistics, Regulatory Affairs, and Pharmacovigilance teams
• Manage clinical trial documentation, including the Trial Master File, and ensure inspection readiness
• Lead internal team meetings, sponsor calls, and investigator meetings
• Support audits and regulatory inspections as needed
• Uphold the organization’s mission, values, and commitment to ethical research
• Work with patients, research participants, clinical staff, investigators, sponsors, monitors, and community partners

Project Manager – Clinical Trials

Clinical Research

• Conduct site selection, initiation, routine monitoring, and close-out visits according to the monitoring plan
• Verify informed consent procedures and protection of patient rights and safety
• Perform source data verification (SDV) and source data review (SDR)
• Review and reconcile clinical trial data against source documents
• Query and resolve data discrepancies with site staff
• Monitor investigational product accountability, storage, and dispensing
• Assess site compliance with the protocol, ICH-GCP, and applicable regulations
• Identify, document, and escalate protocol deviations, adverse events, and serious adverse events
• Maintain and review the Trial Master File (TMF) and site regulatory files
• Build and maintain relationships with investigators, site coordinators, and study staff
• Track site performance metrics, including enrollment, query resolution, and data entry timelines
• Prepare monitoring visit reports and follow-up letters
• Support site staff training on protocols, study procedures, and data entry systems
• Assist with audit and regulatory inspection preparation and follow-up
• Act as the primary point of contact between the sponsor/CRO and investigative sites
• Safeguard data integrity and patient safety throughout the trial lifecycle
• Uphold the organization’s mission, values, and commitment to ethical research
• Participate in training, team meetings, quality improvement, accountability, collaboration, and continuous learning activities

Clinical Research Associate

Data Specialist

• Enter study, participant, clinical, operational, and program data into approved databases, spreadsheets, electronic data capture systems, or sponsor platforms
• Review source documents, forms, surveys, electronic health record data, and other data sources for completeness and consistency
• Maintain logs, trackers, and databases for enrollment, visits, outcomes, follow-up, deliverables, and reporting requirements
• Identify missing, incomplete, or inconsistent data and follow up with appropriate team members
• Conduct routine data quality checks for errors, duplicates, missing fields, outliers, and inconsistencies
• Assist with data cleaning, reconciliation, validation, and resolution of data queries
• Maintain documentation of data corrections, updates, and quality checks
• Assist in developing and updating data dictionaries, codebooks, and naming conventions
• Prepare routine and ad hoc reports for research leadership, investigators, sponsors, funders, and internal teams
• Support dashboards, performance trackers, and visual summaries of study or program progress
• Track enrollment, retention, visit completion, screening outcomes, data completeness, and reporting deadlines
• Assist with grant reporting, study progress reports, quality improvement updates, and leadership summaries
• Maintain electronic files, data repositories, and study-specific data systems
• Support setup and maintenance of data collection tools, forms, surveys, and tracking systems
• Assist with user access, data security, and role-based permissions
• Support integration of data from electronic health records, survey tools, REDCap, Excel, sponsor portals, and shared drives
• Ensure data files are stored, named, and maintained according to organizational and study-specific procedures
• Support audit readiness and maintain data-related study files
• Notify supervisors of data concerns, confidentiality issues, or significant inconsistencies
• Collaborate with Clinical Research Coordinators, research staff, investigators, supervisors, clinical teams, grant staff, and leadership
• Participate in research, grant, evaluation, and quality improvement meetings
• Provide basic technical assistance with data collection tools and reporting templates
• Support accuracy, accountability, compliance, and continuous improvement

Compliance

• Manage and maintain regulatory documentation and compliance requirements for clinical research studies, clinical trials, and human subjects research projects
• Support study start-up, including protocol and sponsor-material review, feasibility, start-up checklists, document collection, and study readiness
• Prepare, coordinate, submit, and track IRB applications, amendments, continuing reviews, reportable events, and study closures
• Maintain current IRB approvals, consent forms, recruitment materials, protocol documents, and version-controlled participant-facing materials
• Develop and maintain regulatory binders or electronic regulatory files
• Maintain complete, accurate, and inspection-ready essential regulatory files
• Support internal quality checks, sponsor monitoring visits, IRB audits, FDA inspections, and internal compliance reviews
• Assist with monitor findings, audit observations, corrective action requests, protocol deviations, noncompliance issues, reportable events, and regulatory follow-up
• Track research staff training, delegation of authority logs, certifications, licenses, and onboarding requirements
• Assist with research regulatory SOPs, templates, trackers, and workflows
• Communicate regulatory requirements and serve as liaison among investigators, research coordinators, sponsors, IRBs, monitors, and organizational leadership
• Participate in study team meetings and provide updates on regulatory status, outstanding documents, and upcoming deadlines
• Support compliance, research integrity, and participant protection

Project Manager – Clinical Trials

Clinical Research Associate

Data Specialist

Regulatory Specialist