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Jobs at SystImmune (Now Hiring) — 12 open

SystImmune logoSystImmune

Sr. Clinical Research Associate

Princeton, New Jersey, United States · Remote OK

$90k–$130k/yr

Senior

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 …

Skills: Oncology Trial Monitoring, ICH-GCP Guidelines, Site Management, Patient Recruitment, EDC Systems

SystImmune logoSystImmune

Senior Project Manager

Redmond, Washington, United States · On-site

$60k–$85k/yr

Senior+

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 …

Skills: Project Management, Cross-functional Leadership, Drug Development, Oncology Biologics, IND Submission

SystImmune logoSystImmune

Scientist, Immuno-Oncology

Redmond, Washington, United States · On-site

$90k–$110k/yr

Entry level

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 …

Skills: Cellular Biology, Molecular Biology, Immunology, Assay Development, Mammalian Cell Culture

SystImmune logoSystImmune

Medical Writer

Princeton, New Jersey, United States · Remote OK

$80k–$130k/yr

Mid level

Located in Redmond WA, SystImmune, Inc. is a biopharmaceutical company focused on treating cancer through developing novel therapeutic multi-specific antibodies and antibody-drug conjugates (ADCs). Our objective is to cr…

Skills: Medical Writing, Clinical Study Protocols, Clinical Study Reports, IND Applications, Investigator Brochures

SystImmune logoSystImmune

Manager/Senior Manager, Clinical Finance Business Partner

Redmond, Washington, United States · On-site

$90k–$140k/yr

Senior

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 …

Skills: Financial Planning And Analysis, Budgeting, Forecasting, Financial Modeling, Data Analysis

SystImmune logoSystImmune

Clinical Accountant

Redmond, Washington, United States · On-site

$60k–$90k/yr

Mid level

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 …

Skills: Financial Accounting, Clinical Trial Cost Tracking, Invoice Processing, Financial Reporting, Variance Analysis

SystImmune logoSystImmune

PV Operations Specialist

Princeton, New Jersey, United States · Hybrid

$85k–$115k/yr

Mid level

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 …

Skills: Pharmacovigilance Case Processing, Regulatory Submissions, Safety Database Management, CAPA Management, ICSR Triage

SystImmune logoSystImmune

Clinical Supplies Manager

Princeton, New Jersey, United States · On-site

$80k–$120k/yr

Senior

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 …

Skills: Clinical Supply Chain Management, Pharmaceutical Operations, GMP Compliance, GCP Compliance, Vendor Management

SystImmune logoSystImmune

Clinical Data Manager

Redmond, Washington, United States · On-site

$100k–$170k/yr

Mid level

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, m…

Skills: Clinical Data Management, SAS Programming, R Programming, EDC Systems, CDISC Standards

SystImmune logoSystImmune

Director, Clinical Data Management

Redmond, Washington, United States · On-site

$190k–$250k/yr

Senior+

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 …

Skills: Clinical Data Management, Strategic Leadership, CDISC Standards, EDC Systems, Regulatory Submissions

SystImmune logoSystImmune

Senior Clinical Research Associate-Contractor

Princeton, New Jersey, United States · Remote OK

Senior

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA and Princeton, NJ. The company specializes in developing innovative cancer therapies through its established …

Skills: Oncology Monitoring, ICH-GCP, Site Management, Source Data Verification, Clinical Trial Oversight

SystImmune logoSystImmune

PV Operations Specialist

Princeton, New Jersey, United States · Hybrid

$85k–$115k/yr

Mid level

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 …

Skills: Pharmacovigilance Case Processing, Regulatory Submissions, Safety Database Management, CAPA Management, ICSR Triage

SystImmune logo

Sr. Clinical Research Associate

SystImmune

Princeton, New Jersey, United States • Remote OK

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Senior

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  • $90k–$130k/yr
  • Full-time
  • bachelor degree
  • Medical Insurance, Dental Insurance, Vision Insurance, Short Term Disability, Long Term Disability, 401(k) Plan With Company Match
  • Posted 2d ago
  • Apply by Sep 24
  • ~40 hrs/week
  • Remote in Princeton, New Jersey, United States

Responsibilities

The Sr. CRA manages and oversees clinical study sites to ensure data quality and patient safety in compliance with ICH-GCP guidelines. Key duties include performing site visits, managing patient recruitment, and maintaining the Trial Master File.

Requirements

Requires a Bachelor's degree in health science and over 5 years of experience independently monitoring oncology trials. Candidates must be proficient in clinical trial systems and capable of traveling 50-75% of the time.

Full 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 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 - $130,000 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.

Related keywords

OncologyClinical Research AssociateICH-GCPBiopharmaceuticalsAntibody-Drug ConjugatesEDCeCRFCTMSeTMFTrial Master FileSAESite Initiation VisitInterim Monitoring VisitClose Out VisitPatient RecruitmentClinical Operations

About SystImmune

LinkedInVisit site
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2014
Headquarters
Redmond, Washington
LinkedIn followers
24,700

Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.

Offices: 15318 NE 95th St, Redmond, Washington, US

Health CareBiopharmaProfessional ServicesBiotechnologyTherapeutics
View all jobs at SystImmune

About SystImmune

LinkedInVisit site
Industry
Biotechnology Research
Company size
51-200 employees
Founded
2014
Headquarters
Redmond, Washington
LinkedIn followers
24,700

Located in Redmond WA, founded in 2014, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor. We are a group of highly experienced immuno-oncology scientists utilizing several technology platforms to develop world class advanced antibody-based drug therapies.

Offices: 15318 NE 95th St, Redmond, Washington, US

Health CareBiopharmaProfessional ServicesBiotechnologyTherapeutics
View all jobs at SystImmune

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