Clinical Trials Operations Consultant (Clinical Research Coordinator)

Job Summary

Department-Specific Responsibilities

• Leads operational feasibility reviews with principal investigators (PI).
• Coordinates with contracting, budgeting, and regulatory teams for process alignment.
• Builds predictable activation timelines based on study type/complexity.
• Tracks bottlenecks and proposes operational fixes (e.g., template language, standard budget grids).
• Supports standardization by upskilling Clinical Research Centers (CRC) and improving team readiness.
• Helps to establish and implement Department of Medicine (DoM) study start up procedures.
• Assists with Institutional Review Board (IRB) submissions (initial, continuing review, amendments).
• Prepares regulatory binders and essential documents.
• Coordinates contract/budget logistics with sponsors and research administration.
• Develops study workflows within clinic operations.
• Sets up study materials (CRFs, REDCap, source templates).
• Prepares for sponsor site initiation visits.
• Maintains training curriculum aligned to good clinical practice (GCP), standard operating procedures (SOP), and process improvements.
• Develops onboarding pathways for CRCs and new hires.
• Conducts periodic quality assurance (QA) reviews and feedback loops for teams (mirroring Clinical Research Leader QA expectations).
• Supports certification readiness (Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP)).
• Assists in building subject identification workflows.
• Develops recruitment tracking dashboards, materials and strategies.
• Tracks enrollment barriers and implements process fixes (e.g., automated screening tools, pre-screening criteria).
• Creates "enrollment rescue plans" for underperforming trials.
• Oversees documentation standards across CRC teams.
• Runs periodic audits (regulatory binders, consent processes, deviation tracking).
• Liaises with IRB office to ensure process alignment.
• Creates risk mitigation frameworks for common protocol deviations.
• Leads special initiatives tied to upcoming strategic plans or trial expansion.
• Supports the Director of Research Administration.
• Builds business cases for resource allocation (CRC staffing, FTE leveling).
• Conducts performance analytics and forecasting for trial volume, staffing, and activation timelines.
• Supports partnerships (industry, academic collaborations).

General Responsibilities

• Oversees day-to-day activities of the projects.
• Manages project staff's interaction with participants and data collection; assesses and ensures that staff follow protocols and standard operating procedures.
• Manages the recruitment of study participants according to approved methodologies; ensures that study staff correctly assess eligibility and carry out the informed consent process with participants.
• Measures projects' progression toward successful completion of project goals; plans and ensures all corrective action and implementation.
• Maintains fiscal oversight; prepares budget modification requests to sponsor as needed; reconciles study budget accounts with business manager.
• Oversees proper project closure including finalizing all qualitative and quantitative data and handing off any project deliverables such as study created decision aids, educational materials, and result summaries to the sponsor, stakeholders, and external partners.
• Coordinates the design and development of all databases that will ensure the accurate tracking of all individuals approached for studies and the safety and security of all data.
• Determines the activities, sequence and time allotted for each activity, and the resources required to achieve the projects' goals.
• Develops project plans including risk management plans; continuously assesses and updates the plans throughout the projects' life cycle.
• Works with project teams to develop all required material including but not limited to advertising, recruitment brochures and letters, surveys, and educational materials for research participants and stakeholders.
• Coordinates activities of the project team including staff, operations support, consultants, vendors, patient, and community advisory boards, and co-investigators; fosters accountability and ensures that all project team members feel supported in their roles.
• Develops schedules for project staff.
• Assists in developing, writing, and submitting research proposals. Coordinates meetings and compiles proposal documents. Writes sections of the proposal especially the methods and human subjects' sections. Prepares the proposal budget and justification in conjunction with other stakeholders.
• Responsible for accurate preparation and timely submission of all regulatory documents.
• Maintains current knowledge of regulatory affairs and/or issues; maintains a high level of expertise through familiarity of clinical literature and attending continuing education classes.