Clinical Research Associate II - Oncology

Responsibilities

Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits

Prepare the study reference manual, including liaising with the Contract Research Organization (CRO) team (i.e., central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites

Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug

Assist in the development of study/program plans (i.e., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan, etc.)

Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)

Monitor recruitment, data quality and patient safety while on site and remotely through EDC systems and direct site communication

Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries

Maintain project files including ethics committee approvals, curricula vitae of investigators and study personnel, clinical investigators brochure, protocols, case report forms instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, lab reference ranges, and all investigator and site correspondence

Identify and complete follow- up of SAEs at study sites

Assist with data listing, data coding, patient profile reviews, database lock, and site close-out activities

Ensure appropriate and timely submission of documents to the Trial Master File

Perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP

Benefits

100% paid employee premiums for medical/dental/vision

STD

LTD

A 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years

15 PTO days per year

Sick leave

11 paid holidays

An opportunity for you to learn and grow while making significant contributions to the company’s success

SystImmune is a biotechnology company.

Redmond, Washington, USA

https://www.systimmune.com

Growth Stage

Recent News

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Anti-human ror1 antibody-drug conjugate and uses thereof

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Qualifications

high quality, ambitious and experienced

self-motivated, independent, and able to work in a small team environment

a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities

Bachelor's degree in health science or related field

2+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits

Excellent verbal and written communication skills

Excellent organizational, multi-tasking and time management skills

Demonstrated experience developing/maintaining site relationships and securing compliance

Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines

Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC and eTMF)

High quality, ambitious and experienced

Self-motivated, independent, and able to work in a small team environment

A highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities

Required skills

Oncology Clinical Trial Monitoring, ICH-GCP, Clinical Trial Monitoring Systems CTMS, Clinical Trial Monitoring Systems EDC, Clinical Trial Monitoring Systems eTMF, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft SharePoint, Microsoft Teams, Clinical Site Relationship Management

Experience

2+ years