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Clinical Research Associate

Location : Aguora, CA (Hybrid)
Job Type : Direct
Compensation : 110000.00 USD/YEAR
Hours : Full Time
Travel : No
Relocation : No

Job Description :

Successful medical devices in Clinical Trials is seeking a Clinical Research Associate to join their team of professionals.  Mission base company that helps people with heart problems.


Support monitoring manager and monitoring team with operational activities, including preparation and review of reports, metrics, and communications to global team. Assist with other clinical operational activities, consistent with study needs and as assigned by manager.


Duties include but are not limited to: · Support monitoring manager and monitoring team with coordinating and monitoring operational activities. Ability to work independently. · Prepare trending reports for study metrics (e.g., monitoring visits and report timelines, protocol deviations, compliance, query/action item resolution). Escalate identified gaps and risks to monitoring manager. · Assist monitoring manager with coordinating monitor site assignments. · Prepare, communicate, and file monitor meeting minutes. · Prepare and send communications to global monitoring team regarding expectations, project updates, and study milestones. · Assist with coordination of monitor training and training records. · Assist monitoring manager with oversight of Monitoring Plan requirements, appropriately escalate identified risks · Provide input on study protocol, Monitoring Plans, CRFs and other study and clinical operations documents (e.g. forms, SOPs, step guides) · Complete special projects and other monitoring and clinical operations tasks as assigned by manager · Position may be remote (2-3 days a week)


 


Required Qualifications :
Knowledge Required: · Bachelor’s degree (or equivalent) in a related field of study and at least 2 years clinical research experience. Preference for experience with cardiovascular medical device clinical trials. · Working knowledge of medical terminology, FDA regulations, ICH/GCP, Clinical Practice, Good Documentation Practices and 21CFR Part 11. · Excellent communication, organization, and problem-solving skills. · Attention to detail and accuracy. · Experience in responding rapidly to changing priorities and in managing aggressive deadlines. Able to manage multiple tasks. · Ability to work with remote teams. · Working knowledge of Microsoft Office applications, Adobe, DocuSign, etc. · Experienced working with clinical systems (e.g. EDC, CTMS, eTMF, EMR)
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