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  3. Clinical Research Associate II
Systimmune logo

Clinical Research Associate II

Systimmune·Princeton, New Jersey

$80,000 - $110,000/yr·Full Time·Remote Ok·Remote friendly·
2-5 yrs
·Posted 2 months ago
Practice for this role

About the role

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

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 $80,000 - $110,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.

Requirements

Candidates must have a Bachelor's degree in health science and at least 2 years of experience independently monitoring Oncology trials. Proficiency in clinical trial systems like EDC and eTMF, along with the ability to travel 50-75%, is required.

  • bachelor degree
  • Time Management
  • Multi-tasking
  • Communication Skills
  • Microsoft Office
  • Patient Recruitment
  • Data Quality Oversight
  • ICH-GCP Guidelines
  • CTMS
  • EDC Systems
  • Site Management
  • Clinical Monitoring
  • Oncology Trial Management
  • TMF Maintenance
  • IP Inventory Management
  • SAE Follow-up
  • eCRF Management

Posting details

Employment type
Full Time
Work arrangement
Remote Ok
Experience
2-5 yrs
Salary
$80,000 - $110,000/yr
Location
Princeton, New Jersey
Posted
May 21, 2026
Closes
Aug 19, 2026
Application
Employer website
Systimmune logo

Hiring organization

Systimmune

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...

Salary listed on 4 jobs
IndustryBiotechnology Research
TypePrivately Held
Size51-200 employees
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Market context

Oncology CRA roles stay competitive

In New Jersey, Clinical Research Associate II roles in oncology are often driven by active trial pipelines and the need for monitors who can work independently. This category is competitive because employers look for candidates with oncology monitoring experience, strong EDC and eTMF skills, and the flexibility to travel 50-75%. Review the AI-summarized requirements and benefits here to save time, then tailor your application to show direct oncology monitoring experience and system proficiency.

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