Clinical Research Coordinator, Open Rank

About the Role

The Clinical Research Coordinator (CRC) supports a portfolio of lupus studies within the Division of Rheumatology, including the Lupus Nexus registry and biorepository, the CurLi translational study, and industry-sponsored and investigator-initiated clinical trials in systemic lupus erythematosus. This is an open-rank posting; candidates will be hired into a level commensurate with their experience.

Key Responsibilities

• Independently perform delegated tasks and procedures involving human subject research.
• Coordinate regulatory activities and data collection/management for research protocols related to treatment, ancillary services, and prevention practices.
• Obtain informed consent from research participants.
• Identify, schedule, and/or conduct participant study visits, tests, and/or interviews/telephone follow-up calls.
• Coordinate participant remuneration/compensation per protocol.
• Maintain all regulatory documentation, including local or central IRB and study data.
• Provide data/support to study Investigators, sponsors, and/or external monitors/auditors.
• Identify issues with protocol compliance and keep the principal investigator and manager informed.
• Document and collect data and/or samples for research-related procedures performed during participant study visits.
• Ensure clinicians and/or PI accurately document their study activities according to protocol.
• Track and maintain study enrollment and completion of milestones.
• Assist with financial/operational aspects of grants and contracts.
• Track and maintain study-related information in the data management system within the required timeframe.
• Monitor the inventory of research-related supplies.
• Participate in grant preparation, manuscript writing, data presentations, and Institutional Review Board (IRB) processes.
• Provide detailed written summaries from literature searches and related sources.
• Present study status reports related to assigned research projects.
• Participate in the design, development, and documentation of study-related data and collection tools (e.g., questionnaires, treatment data, therapeutic checklists).
• Maintain strict adherence to all study protocols, including regulatory requirements.
• Comply with all safety and infection control standards.
• Adhere to established policies, health and safety regulations, procedures, and department objectives.
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices.
• Practice discretion and adhere to school and hospital confidentiality at all times.
• Identify, screen, and recruit eligible patients.
• Collect, process, and ship biospecimens per protocol and laboratory manuals; maintain sample logs and chain of custody.
• Administer questionnaires and collect patient-reported outcomes; abstract clinical data from the medical record.
• Enter data into electronic data capture systems and registry platforms with timely query resolution.
• Maintain regulatory files and support IRB submissions, amendments, continuing reviews, and adverse event reporting.
• Prepare for and participate in sponsor monitoring visits and audits.
• Track enrollment and visit metrics; communicate study status to investigators and sponsors.
• Collaborate with investigators, research laboratory staff, and the study team.
• Direct/Supervise the activities of research support staff and assist with training, selection, and supervision.
• Prepare ongoing summary reports from various data sources.
• Collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals.
• Accountable for quality assurance reviews of study data.
• Responsible for clinical research billing review within the required timeframe.
• Assess protocol feasibility.

Requirements & Tech Stack

• HIPAA
• IRB
• GCP
• Electronic data capture systems
• Registry platforms
• Data management systems

Qualifications

• Clinical Research Coord I:
• Bachelor's degree in a scientific or health-related field, or equivalent experience.
• 0-1 year of related experience.
• Ability to travel to off-site locations.
• Clinical Research Coord II:
• Requirements noted for CRC I plus:
• 1-3 years of related experience.
• Clinical Research Coord III:
• Requirements noted for CRC I plus:
• 3-5 years of related experience.
• Sr Clinical Research Coord:
• Requirements noted for CRC I plus:
• 5-7 years of related experience.
• Demonstrated knowledge of quality management principles in a scientific or hospital setting.

Preferred: Prior clinical research experience, familiarity with GCP and human subjects protections, phlebotomy or specimen handling experience.