Study Lead, Clinical Research Coordinator

Folio Clinical Research; Tustin (CA); On-site; USD 33,000 - 48,000; Full time

Job summary

Folio Clinical Research in Tustin, CA is seeking a Clinical Research Coordinator to support the conduct of clinical trial activities, ensuring regulatory compliance and aiding study operations across multiple trials.

The role requires strong attention to detail, ability to prioritize in a fast-paced environment, and effective collaboration with investigators, site staff, and sponsors to support successful study execution.

Qualifications

• Minimum of one year of Clinical Research Coordinator experience or two years Clinical Research Assistant of pharmaceutical/medical device FDA studies.
• Experience with various Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and electronic Trial Master File (eTMF) systems.
• Knowledge of ICH-GCP, and regulatory requirements, with the ability to implement these effectively throughout the clinical trial.
• Experience with data management processes, ensuring the accuracy and completeness of data collection, entry, and reporting, in line with Good Clinical Data Management Practices (GCDMP).
• Experience ensuring and prioritizing patient safety and data integrity, embodying a commitment to the ethical conduct of clinical trials.
• Experience maintaining the highest quality standards, while focusing on ongoing process improvements that lead to enhanced clinical trial efficiency and compliance.
• Excellent interpersonal communication, both written and verbal. Can easily interface with team members, physicians, and external partners.
• Strong attention to detail, and ability to handle multiple tasks simultaneously in a dynamic research environment.
• Strong computer skills (MS Office, M PowerPoint, etc.) and software experience (CTMS, eTMF, EDC, IXRS, RTSM, etc.)
• Ability to prioritize tasks, effectively manage time, and allocate resources efficiently to meet tight study deadlines.
• Bachelor's degree or equivalent combination of education/experience in science or health-related field.
• Phlebotomy experience preferred.

Responsibilities

• Assist the PI/SI and other CRCs with clinical trial tasks such as lab processing, data entry, and subject pre-screening, recruitment, and scheduling.
• May be assigned as primary resource on several clinical research studies and has the ability, experience, and passion to own those studies from qualification to close-out.
• Assist the Company, Folio, with setting up the site, calibrating equipment, and ordering necessary supplies to be productive and successful.
• Attend SQVs, SIVs, and monitoring visits with the PI/SI with little / no support. Can be assigned as the primary liaison to ensure the studies are prepared for initiation and the site is ready for FPV (first patient visit), FPS (first patient screening), and FPE (first patient enrollment).
• Support the CRCs, Clinical Research Assistants, and Regional Managers with the overall growth of the clinical research program at the site.
• Support unblinded study responsibilities where needed to leverage resources and ensure study success. Use strategies to support clinical operations while ensuring the study blind is not broken.
• Ensure adherence to regulatory guidelines such as Good Clinical Practice (GCP), Good Documentation Standards, ALCOA-C++, and Institutional Review Board (IRB) protocols and other applicable laws and policies which govern the industry.
• Work closely with the PI/SI, CRC and other staff to ensure the smooth conduct of clinical studies in a compliant manner.
• Aid in the adoption and growth of technology throughout the site network. We are a data driven organization. Assist with expansion of our clinical trial management system, electronic source, electronic regulatory and our central clinical services to support on-site research operations.

Skills

Attention to detail

Communication

Team collaboration

Prioritization

Fast-paced environment

Multitasking

Education

Bachelor's degree

Equivalent education/experience in science or health

Tools

EDC

CTMS

eTMF

MS Office

PowerPoint

IXRS

RTSM

Job description

Folio Clinical Research in Tustin, CA is seeking a Clinical Research Coordinator to support the conduct of clinical trial activities, ensuring regulatory compliance and aiding study operations across multiple trials.

The role requires strong attention to detail, ability to prioritize in a fast-paced environment, and effective collaboration with investigators, site staff, and sponsors to support successful study execution.