Clinical Research Coordinator - Open Rank
About The Position
The Clinical Research Coordinator works under the direction of a Principal Investigator (PI) or designee and independently performs delegated tasks and procedures involving human-subject research. The role coordinates regulatory activities and supports the collection and management of data for research protocols related to treatment, ancillary services, and prevention practices. This is an open-rank posting with four levels; candidates are hired at a level commensurate with their experience. The position supports a portfolio of lupus studies in 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. Work includes identifying, screening, and recruiting eligible patients; obtaining informed consent; coordinating protocol visits and follow-up; collecting and processing biospecimens; administering questionnaires; abstracting clinical information; and entering data into electronic data capture and registry systems. The coordinator maintains regulatory files and supports IRB submissions and related activities, adverse event reporting, monitoring visits, and audits. The role tracks enrollment and study milestones, communicates study status, collaborates with investigators and research staff, and contributes to data quality, study documentation, reports, presentations, manuscripts, and grant work. Higher-level positions may direct or supervise research support staff and assume greater responsibility for quality assurance, study operations, and independent contributions to research activities.
Requirements
- Bachelor’s degree in a scientific or health-related field, or equivalent experience.
- Clinical Research Coordinator I: 0–1 year of related experience.
- Clinical Research Coordinator II: 1–3 years of related experience.
- Clinical Research Coordinator III: 3–5 years of related experience.
- Senior Clinical Research Coordinator: 5–7 years of related experience.
- Ability to travel to off-site locations.
- Senior Clinical Research Coordinator: demonstrated knowledge of quality management principles in a scientific or hospital setting.
- Adherence to Good Clinical Practice (GCP), human-subject protection practices, applicable regulations, and study protocols.
Nice To Haves
- Prior clinical research experience.
- Familiarity with Good Clinical Practice (GCP) and human-subject protections.
- Phlebotomy or specimen-handling experience.
Responsibilities
- Obtain and document informed consent in accordance with IRB-approved protocols, HIPAA, applicable regulations, and human-subject protection practices.
- Identify, screen, recruit, schedule, and maintain study participants; conduct study visits, tests, interviews, and follow-up calls in accordance with protocol schedules.
- Coordinate participant remuneration and compensation as specified by study protocols.
- Collect, document, process, and ship biospecimens, including blood and urine, according to protocols and laboratory manuals; maintain sample logs and chain of custody.
- Administer questionnaires, collect patient-reported outcomes, and abstract clinical data from medical records.
- Enter and maintain study information in data management, electronic data capture, and registry systems within required timeframes, and resolve data queries promptly.
- Maintain regulatory documentation and files, including local or central IRB materials; support submissions, amendments, continuing reviews, and adverse event reporting.
- Provide study data and support to investigators, sponsors, external monitors, and auditors; prepare for and participate in monitoring visits and audits.
- Track study enrollment, completion of milestones, visit metrics, and study status; communicate relevant updates to investigators and sponsors.
- Identify protocol-compliance issues, resolve them as appropriate to the role, and keep the PI and manager informed.
- Ensure clinicians and investigators accurately document study activities according to protocol.
- Conduct preliminary and, at higher levels, accountable internal quality assurance reviews of study data; report findings as applicable.
- Coordinate day-to-day operation of assigned studies and collaborate with investigators, clinicians, sponsors, laboratory staff, and research team members to meet timelines and goals.
- Monitor research-related supply inventory.
- Assist with financial and operational aspects of grants and contracts, including clinical research billing review within required timeframes where applicable.
- Participate in grant preparation, protocol feasibility assessment, manuscript writing, data presentations, literature searches, and IRB processes; prepare summaries and reports and collaborate on data interpretation and publication.
- Participate in the design, development, and documentation of study data collection tools; higher-level coordinators may develop preliminary designs and contribute independently.
- At higher levels, direct or supervise research support staff and assist with staff selection, training, and supervision.
- Follow study protocols, Good Clinical Practice guidelines, federal, local, and institutional requirements, safety and infection-control standards, applicable policies, and confidentiality requirements.
- Perform other duties as required.
- Travel to off-site locations.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
