What are the responsibilities and job description for the Clinical Trial Associate position at Iconma LLC?
Clinical Trial Associate
Location: San Bruno, CA / Hybrid
Duration: 6 months with possible extension
Description: -
Responsibilities:
Oversee/collaborate all operational aspects for the implementation of clinical study activities from study start-up through database lock, ensuring relevant practices (e.g. Good Clinical Practices, Good Pharmacoepidemiology Practices, Common Rule) and relevant Standard Operating Procedures (SOPs) are met.
Work closely with cross-functional teams on clinical study delivery for Client sponsored and externally Sponsored research projects.
Drive development of study-related materials, such as Monitoring Plans, Trial Master File Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, informed consent, site instructions/training, and other aspects of study operations.
Review monitoring/data reports, protocol deviations to ensure reliable quality data is delivered; coordinate/manage Contract Research Organizations (CROs) on site selection, Institutional Review Board (IRB) submissions, site initiation and close-out planning.
Communicate directly with study site staff and investigators; track patient recruitment and progress to study timelines; support safety reporting and IRB submissions; maintain and report metrics for clinical site performance.
Qualifications:
Minimum qualifications:
BA/BS/BScN degree in health or biologic science, or equivalent practical experience.
Experience in study project management and prior management of contracted resources/CROs.
5 years of clinical study management experience in registries, observational research, RWD/E, or device research as a clinical study lead/project manager.
Preferred qualifications:
Experience managing decentralized clinical studies (DCTs) and deploying DCT solutions.
Experience with RWD/E generation research (e.g., registries, observational research, RWD collection).
Experience in medical device deployment and study management
Experience in site monitoring, clinical quality compliance and international study management.
In depth knowledge of Good Clinical Practices, Good Pharmacoepidemiology Practice and current knowledge of FDA regulations for human subjects research, and strong understanding of clinical study systems (TMF, EDC, etc).
Experience:
5-10 Years
