Role: Clinical Research Associate
Location: Alameda, CA - 94502
Duration: 06+ Months
Description:
Clinical Research Associate:
This position will include monitoring and oversight of clinical sites to ensure timely and successful execution of clinical studies, resolving study-related discrepancies.
This position will ensure compliance with protocol and all regulatory policies, procedures, and/or guidelines during clinical studies by training/guidance of investigators/study coordinators, and follow-up of corrective actions.
Also, will ensure validity of study by identifying/resolving discrepancies and obtaining missing data and may track more routine aspects of a study. of clinical documents, which may include protocols, case report forms (CRFs), memos, correspondence, reports, and other required documents. Also, conduct new CRA orientation, onboarding, and training activities.
Candidate will proactively identify, and address issues related to study monitoring and clinical site management.
Track and communicate monitoring and site management updates and issues; escalate monitoring-related study timeline and quality risks to the Clinical leadership.
Maintain clinical operations processes, new employee onboarding, internal protocol training, monitoring tracking tools and study tools/templates for CRAs and site personnel.
Manage CROs/vendors for outsourced activities as applicable, including sponsor oversight of relevant functional activities (e.g., study management, monitoring, site management, project master files, and data management).
Ensure adherence to Good Clinical Practices, Industry standards, standard operating procedures and to all other regulatory and quality standards in conducting Lingo Clinical research and development.
Education:
Bachelor's degree-Major/Field of Study- Biology, Health Sciences, Mathematics, Computer Science, or equivalent
Licenses and Certifications: None required; Certified Clinical Data Manager (CCDM) or equivalent nice to have but not required