ClinLab Staffing
Clinical Research Coordinator (CRC) Job Functions & Responsibilities
Provide administrative support to the Clinical Research Department and assist Project Managers and Principal Investigators.
Support the research team with the ongoing conduct of studies, ensuring compliance with ICH GCP, regulatory requirements, SOPs, and internal tracking systems.
Assist project teams with study-specific documentation and guidelines as appropriate.
Set up, organize, and maintain clinical study documentation (e.g., study files, CRFs), including preparation for audits, reconciliation, and archival.
Process data collection forms (log in, tracking, quality control) and assist with quality control audits of study documentation.
Coordinate ordering, distribution, and tracking of trial and office materials (CRFs, lab supplies, investigational products, etc.).
Update Clinical Trial Management Systems (CTMS) to track trial progress.
Assist in coordination of site payments and reimbursements and track pending payments.
Serve as the primary coordinator for assigned studies, collaborating closely with the PI and Project Manager.
Travel between clinical sites as needed to support enrollment updates, documentation, meetings, and staff training.
Track and distribute safety reports, assist with monitoring visit follow-up, and help resolve audit findings.
Participate in weekly project team meetings and communicate updates to the broader team.
Create source documents, assist with patient visits, and support in reporting adverse events as required.
Contribute to presentations and training materials for internal and sponsor use.
Perform other duties as assigned.
Required Skills & Attributes
Strong interpersonal and communication skills.
Proficient in Microsoft Office Suite.
Excellent organizational and time management skills.
Bachelor’s degree in applied or life science with at least 2 years of clinical research experience (or equivalent training/experience).
Willingness to travel between clinical sites as needed.
Experience with ophthalmology clinical trials preferred.
Fully bilingual in English and Spanish (read, write, and speak) preferred.
Provide administrative support to the Clinical Research Department and assist Project Managers and Principal Investigators.
Support the research team with the ongoing conduct of studies, ensuring compliance with ICH GCP, regulatory requirements, SOPs, and internal tracking systems.
Assist project teams with study-specific documentation and guidelines as appropriate.
Set up, organize, and maintain clinical study documentation (e.g., study files, CRFs), including preparation for audits, reconciliation, and archival.
Process data collection forms (log in, tracking, quality control) and assist with quality control audits of study documentation.
Coordinate ordering, distribution, and tracking of trial and office materials (CRFs, lab supplies, investigational products, etc.).
Update Clinical Trial Management Systems (CTMS) to track trial progress.
Assist in coordination of site payments and reimbursements and track pending payments.
Serve as the primary coordinator for assigned studies, collaborating closely with the PI and Project Manager.
Travel between clinical sites as needed to support enrollment updates, documentation, meetings, and staff training.
Track and distribute safety reports, assist with monitoring visit follow-up, and help resolve audit findings.
Participate in weekly project team meetings and communicate updates to the broader team.
Create source documents, assist with patient visits, and support in reporting adverse events as required.
Contribute to presentations and training materials for internal and sponsor use.
Perform other duties as assigned.
Required Skills & Attributes
Strong interpersonal and communication skills.
Proficient in Microsoft Office Suite.
Excellent organizational and time management skills.
Bachelor’s degree in applied or life science with at least 2 years of clinical research experience (or equivalent training/experience).
Willingness to travel between clinical sites as needed.
Experience with ophthalmology clinical trials preferred.
Fully bilingual in English and Spanish (read, write, and speak) preferred.