A Clinical Research Associate is responsible for running clinical trials, usually for an organization undertaking pharmacological drug testing. Will ensure that trials adhere to good clinical practice guidelines for monitoring clinical trials.
ASAP Position Overview We are seeking an experienced Clinical Research Monitor to independently conduct onsite and remote monitoring activities for early-phase clinical research studies, including Phase 0 and Phase I trials . The ideal candidate will have strong knowledge of clinical trial monitoring, ICH-GCP, regulatory compliance, source data review, and study documentation. Approximately 8-10 monitoring visits per quarter are expected, with flexible scheduling and advance notice provided for monitoring activities. Experience in Neuroscience/Neurology and imaging research is highly preferred. Key Responsibilities Conduct independent onsite and remote monitoring visits for Phase 0, Phase I, and other assigned clinical studies. Coordinate and schedule monitoring visits directly with research sites. Perform Source Data Verification (SDV) and Source Data Review (SDR) to ensure data accuracy and protocol compliance. Review informed consent forms, source documents, regulatory files, study records, and essential documents. Monitor study conduct for compliance with protocols, sponsor requirements, ICH-GCP , and applicable regulations. Identify, document, communicate, and follow up on protocol deviations, compliance concerns, data discrepancies, and study risks. Prepare accurate and timely monitoring visit reports, confirmation letters, and follow-up correspondence. Follow up with sites to ensure findings and corrective actions are appropriately addressed and closed. Review and resolve EDC queries in collaboration with study teams. Support participant safety, data integrity, quality assurance, and regulatory compliance throughout the study lifecycle. Collaborate with investigators, Clinical Research Coordinators, sponsors, and research teams. Escalate significant findings, risks, and compliance concerns as appropriate. Required Qualifications Bachelor's degree in Life Sciences, Healthcare, Nursing, Public Health, or a related field . Minimum 3 years of clinical research monitoring experience . Proven experience independently conducting onsite and remote monitoring . Hands-on experience monitoring Phase 0 and/or Phase I clinical trials . Experience with source documentation, regulatory documentation, informed consent forms, and essential study records. Experience working with sponsors, investigators, Clinical Research Coordinators, and research sites. Strong ability to identify and follow through on protocol deviations, compliance issues, and monitoring findings. Strong understanding of clinical trial regulations and ICH-GCP . Ability to independently manage monitoring activities with minimal supervision. Preferred Qualifications Additional Phase II clinical trial monitoring experience. Experience in Neuroscience, Neurology, neurodegenerative diseases, and/or imaging research .
ACRP, CCRP, SOCRA
, or equivalent certification. Current GCP certification . Technical Skills Electronic Data Capture ( EDC ) systems Trial Master File ( TMF/eTMF ) Clinical trial monitoring SDV/SDR Regulatory compliance and ICH-GCP Clinical trial documentation and monitoring reports
Microsoft Office Suite Pay:
$75.00 - $80.00 per hour Expected hours: 8.0 per week
