Systimmune

Develops bispecific antibodies and ADCs

Clinical Research Associate 2 - Oncology

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeLos Angeles, CA, USA$90k - $115k /yrIn-person

About the Job

Requirements

A bachelor's degree in health science or a related field.
At least 2 years of independently monitoring oncology trials, including conducting on-site and remote monitoring visits.
Demonstrated experience developing and maintaining site relationships and securing compliance.
Working knowledge of International Council for Harmonisation Good Clinical Practice guidelines.
Experience with Microsoft Office products (Word, Excel, PowerPoint, SharePoint, and Teams) and clinical trial systems such as CTMS, EDC, and eTMF.
Ability to travel as required, 50–75%.
Strong verbal and written communication skills.
Strong organizational, multitasking, and time-management skills.

Responsibilities

Conduct Site Evaluation Visits, Site Initiation Visits, interim monitoring visits, and Close Out Visits.
Prepare the study reference manual and coordinate with the Contract Research Organization team, including central and specialty laboratories and vendors, to prepare and deliver study materials to investigator sites.
Ensure investigator sites meet contractual and regulatory requirements for site initiation and first release of study drug.
Assist in developing study and program plans, including the Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, and Safety Management Plan.
Manage patient recruitment strategies by identifying recruitment barriers and proposing solutions, such as study-site webinars and newsletters.
Monitor recruitment, data quality, and patient safety on site and remotely through EDC systems and direct site communication.
Liaise with study-site personnel to ensure timely and accurate eCRF data entry, including timely resolution of data queries.
Maintain project files, including ethics committee approvals, investigator and study-personnel curricula vitae, the clinical investigators brochure, protocols, case report form instructions, consent documents, clinical-trial material shipping orders, start-up meeting attendance documentation, letters of agreement, laboratory reference ranges, and investigator and site correspondence.
Identify and complete follow-up of serious adverse events at study sites.
Assist with data listings, data coding, patient profile reviews, database lock, and site close-out activities.
Ensure timely and appropriate submission of documents to the Trial Master File.
Conduct investigational product inventory and reconciliation, and review storage and security. Verify investigational product is dispensed and administered according to protocol, and verify issues or risks related to blinded or randomized investigational product information.

SystImmune is seeking a high quality, ambitious and experienced Clinical Research Associate II (CRA II) to support SystImmune’s clinical trials. The CRA II is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient safety in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs. The CRA II 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.

Job 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.

Qualifications:

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 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%)

Compensation and Benefits:

The expected base salary range for this position is $90,000 - $115,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

SystImmune is a leading and 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.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

About the Company

Systimmune

Develops bispecific antibodies and ADCs

Systimmune is a biopharmaceutical company that develops antibody-based cancer therapies, including bispecific and trispecific antibodies and antibody-drug conjugates (ADCs). These products are designed to act on the solid tumor micro-environment to directly attack tumors and/or to activate the immune system to fight cancer. The company uses multiple immuno-oncology platforms and experienced scientists to create biologics that intervene in the tumor environment in systematic ways. Compared with competitors, Systimmune emphasizes integrating several antibody-based modalities (bispecifics, trispecifics, and ADCs) and a deep focus on the solid tumor micro-environment, aiming to translate biological insight into targeted, immune-engaging therapies. The goal is to produce biologics that effectively modulate the tumor environment and mobilize the body's own immune response to destroy cancer cells.

Company size: 11-50
Company stage: Not listed
Total funding: Not listed
Headquarters: Redmond, WA
Founded: 2014

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