Clinical Research Associate II - Oncology

SystImmune, Inc.; Los Angeles (CA); On-site; USD 90,000 - 115,000; Full time

Benefits offered by this job

Premium health benefits

401(k) plan with company match

15 PTO days per year

11 paid holidays

Job summary

SystImmune, Inc. is seeking a Clinical Research Associate II (CRA II) to support its clinical trials. The CRA II will manage and oversee assigned study sites to ensure data quality and patient safety in accordance with ICH-GCP, local regulations, and SOPs.

The role requires strong organization, multitasking, and communication skills with 2+ years of Oncology trial monitoring and travel up to 50–75%. This position offers a base salary range of $90,000–$115,000 per year, plus comprehensive

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%)

Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits
• Prepare the study reference manual, including liaising with the CRO team 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
• 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.

Skills

Communication skills

Organizational skills

Site relationship management

ICH-GCP knowledge

Office & trial systems

Travel readiness

Education

Bachelor's degree in health science or related field

Tools

CTMS

EDC

eTMF

Microsoft Office

SharePoint

Teams

Job description

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.

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.

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.