Clinical Research Associate (San Diego)

Benefits

Qualifications

• •Bachelor’s degree, preferably in science or healthcare
• •Demonstrated clinical research experience with a minimum of 2 years monitoring experience in the biotech/medical diagnostics/pharmaceutical industry, CRO, or in a hospital setting with experience in oncology
• •Good knowledge of applicable clinical research regulatory requirements including Good Clinical Practice and International Conference on Harmonization guidelines
• •Excellent written and verbal communication skills
• •Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint
• •Ability to work independently and prioritize multiple projects in a fast-paced environment
• •Physical / Work Environment
• •4 more items(s)

Responsibilities

• •Reports to : Associate Director Clinical Trial Management
• •We are seeking an in-house Clinical Research Associate with oncology experience to independently monitor and manage clinical sites participating in studies with pegargiminase
• •No travel requirements are anticipated as all monitoring visits will be conducted remotely
• •Additional responsibilities will include support for the maintenance of monitoring related documents and trackers
• •The position will report to the Associate Director Clinical Trial Management and will be hybrid position requiring a minimum of one day per week in the San Diego office
• •We operate in a fast-paced, dynamic environment where employees are expected to be adaptable, flexible, and willing to take on additional responsibilities as required
• •Support study monitoring startup tasks including the development of plans and manuals, training, reviewing, and approving essential documents, facilitating completion of clinical study agreements and shipment of investigation product
• •Perform clinical monitoring activities to ensure that the clinical studies are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures, Good Clinical Practice, and applicable regulatory requirements
• •Independently conduct monitoring visits to ensure accuracy of data entry with source documentation and perform study drug accountability or manage outsourced CRA performing these activities
• •Review clinical site regulatory documents to ensure completeness and retrieve documents for the Trial Master File
• •Maintain the internal Trial Master File and periodically review
• •Support the preparation of project and study-related documents, including informed consent forms, monitoring plans, synopses, protocol and protocol amendments, and clinical summaries as required
• •Monitor and track clinical research progress and provide status update reports
• •Liaise with clinical sites and provide guidance on site/study issues
• •This role is mainly a desk role requiring proper ergonomics
• •12 more items(s)