Senior CRA - Oncology Biotech

SystImmune, Inc.; Redmond (WA); Sur place; USD 90 000 - 140 000; Plein temps

Avantages offerts par ce poste

Medical/dental/vision premiums paid

Short-term disability

Long-term disability

401(k) company match (50% up to 3%)

Vesting in 5 years

15 PTO days per year

Sick leave

11 paid holidays

Résumé du poste

SystImmune, Inc. in Redmond, WA seeks a Senior Clinical Research Associate (CRA) to manage trial sites, ensure data quality and patient safety per ICH‑GCP. The role requires independence, strong organization, and ability to adapt to changing project priorities within a small team.

The Sr CRA will lead site visits, assist in study plans, manage recruitment strategies, monitor data and safety, and maintain essential trial documents. Occasional travel is required.

Qualifications

• 5+ years monitoring Oncology trials with on-site and remote visits.
• Excellent verbal and written communication skills.
• Strong organizational, multi-tasking and time management abilities.
• Experience developing/maintaining site relationships and ensuring regulatory compliance.
• Working knowledge of ICH-GCP guidelines.
• Proficient in Microsoft Office and clinical trial systems (CTMS, EDC, eTMF).

Responsabilités

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits.
• Ensure investigator sites meet contractual and regulatory requirements for site initiation and first release of study drug.
• Assist in the collection of key documents to enable site activation timely.
• Assist in development of study/program plans and SOP updates as directed by the Clinical Project Manager.
• Manage patient recruitment strategies and address barriers to recruitment.
• Monitor recruitment, data quality and patient safety on-site and remotely via EDC.
• Liaise with study site personnel for timely data entry into eCRF and resolution of data queries.
• Maintain project files including ethics approvals, investigator CVs, and study documents.
• Identify and complete follow-up of SAEs at study sites.
• Ensure timely submission of documents to the Trial Master File.
• Perform IP inventory, reconciliation and ensure proper storage and security.

Connaissances

On-site monitoring

Remote monitoring

Verbal and written communication

Organizational skills

Multi-tasking

Time management

Site relationships and compliance

ICH-GCP knowledge

Microsoft Office & CTMS/EDC/eTMF

Formation

Bachelor’s degree in health science or related field

Outils

CTMS

EDC

eTMF

SharePoint/Teams

Description du poste

Systimmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi‑specific antibodies, and antibody‑drug conjugates (ADCs). Systimmune has several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Systimmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND‑enabling stages, representing cutting‑edge biologics development.

Summary:

SystImmune is seeking a high quality, ambitious and experienced Senior Clinical Research Associate (CRA) to support SystImmune’s clinical trials. The Sr. CRA is responsible for the management and oversight of their assigned clinical study sites to ensure document collection, data quality and patient safety in accordance with ICH‑GCP guidelines, local regulations, and applicable SOPs. The Sr CRA must be self‑motivated, independent, and able to work in a small team environment. The successful candidate will be a highly organized individual who can also multitask and adjust direction based on changing project/corporate priorities.

Essential Duties and Responsibilities:

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
• Responsible for ensuring investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug
• Assist and support the collection of key documents from sites to enable site activation timely
• Assist in the development of study/program plans and or SOP Development/updates as directed by the Clinical Project Manager
• 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
• 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.

Required Skills & Qualifications:

• Bachelor’s degree in health science or related field
• 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits
• Excellent verbal and written communication skills required
• Excellent organizational, multi‑tasking and time management skills required
• 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)
• Ability to travel as required (50-75%)

SystImmune is a stable, well‑funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also 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, plus 11 paid holidays and MORE