Clinical Research Coordinator: Lead Trial Operations

Atlas Urology LLC; Tustin (CA); On-site; USD 29,000 - 48,000; Full time

Job summary

Folio Clinical Research in Tustin, CA is seeking a Clinical Research Coordinator to support trial conduct, assist with lab processing, data entry, subject screening, recruitment and scheduling under the PI/SI team.

Ideal candidates have 1 year CRC experience (or 2 years as a Clinical Research Assistant on FDA studies), strong ICH-GCP knowledge, and experience with EDC, CTMS and eTMF; phlebotomy is a plus.

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.

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

Clinical Research Coordinator experien

Attention to detail

Regulatory compliance knowledge

Communication skills

Education

Bachelor's degree or equivalent in science/health

Tools

EDC systems

CTMS

eTMF

IXRS

RTSM

Job description

Folio Clinical Research in Tustin, CA is seeking a Clinical Research Coordinator to support trial conduct, assist with lab processing, data entry, subject screening, recruitment and scheduling under the PI/SI team.

Ideal candidates have 1 year CRC experience (or 2 years as a Clinical Research Assistant on FDA studies), strong ICH-GCP knowledge, and experience with EDC, CTMS and eTMF; phlebotomy is a plus.