Senior Clinical Research Associate -Oncology

SystImmune, Inc.; Los Angeles (CA); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

100% paid medical/dental/visionPremium

STD (Short-Term Disability)

LTD (Long-Term Disability)

401(k) match up to 3%

5 year vesting

15 PTO days

11 paid holidays

Job summary

SystImmune, Inc. is seeking a Senior Clinical Research Associate (CRA) to support our clinical trials. The Sr.

CRA will oversee assigned sites to ensure data quality and patient safety in accordance with ICH-GCP, local regulations, and SOPs. The role requires self-motivation, independence and the ability to work in a small team. We value highly organized individuals who can multitask, manage site relationships, and adapt to changing priorities.

Qualifications

• Bachelor’s degree in health science or related field.
• 5+ years monitoring Oncology trials with on-site and remote visits.
• Excellent verbal and written communication skills.
• Strong organizational and time-management abilities.
• Experience maintaining site relationships and ensuring compliance.
• Knowledge of ICH-GCP guidelines.
• Proficient with CTMS, EDC, eTMF and MS Office; willing to travel 50–75%.

Responsibilities

• Perform Site Evaluation Visits, Site Initiation Visits, Interim monitoring visits and Close Out Visits.
• Coordinate with CROs and labs to ensure delivery of study materials to investigator sites.
• Ensure regulatory requirements for site initiation and first release of study drug.
• Assist in development of study/program plans (Monitoring Plan, eCRF Guidelines, Data Management Plan, Safety Plan).
• Manage patient recruitment strategies and address barriers to recruitment.
• Monitor recruitment, data quality and patient safety on-site and remotely.
• Liaise with site personnel for timely and correct entry of data into eCRF.
• Maintain project files and essential regulatory documents.
• Identify and complete follow-up of SAEs at sites.
• Assist with data listings, coding, and database lock.
• Ensure submission to Trial Master File.
• Perform IP inventory, reconciliation and storage security.

Skills

Oncology monitoring

Communication skills

Organizational skills

Travel readiness

Regulatory compliance

Education

Bachelor’s degree in health science

Tools

CTMS

EDC

eTMF

MS Office

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. 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 multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

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 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.

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.
• 5+ years monitoring Oncology trials independently conducting on-site & 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

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.

• Expected base salary range: $110,000 - $145,000 annually.
• 100% paid employee premiums for medical/dental/vision
• also STD
• LTD
• 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.

SystImmune offers 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.