Clinical Research Associate
We are seeking a motivated Clinical Research Associate (CRA) to join our growing team supporting innovative early-phase oncology clinical trials (primarily Phase I). The CRA will assist in site monitoring activities and work closely with senior team members to ensure trial conduct is aligned with ICH-GCP, protocols, and regulatory requirements. This is an excellent opportunity for someone with CRA experience who is ready to take on broader site management responsibilities while being mentored by senior CRAs and clinical project managers. Responsibilities
- Assist with site qualification, initiation, routine monitoring, and closeout visits Monitor patient safety, protocol adherence, and data integrity during on-site and remote visits.
- Perform source data review (SDR) and source data verification (SDV), ensuring timely resolution of data queries.
- Ensure investigator sites maintain compliance with GCP, protocol, and SOPs, and support inspection readiness efforts.
- Collaborate on the review and tracking of essential documents (e.g., ICFs, regulatory binders).
- Support cohort management activities (e.g., dose escalation, enrollment tracking) as assigned.
- Assist in documentation for Trial Master File (TMF) and site files to ensure completeness and accuracy.
- Provide site training and support for EDC and trial systems Contribute to patient recruitment and retention initiatives at the site level.
- Bachelor’s degree in health sciences or related field.
- 1-5 years of total clinical trial experience (e.g., as CRA, CTA, in-house CRA, or CRC).
- Exposure to oncology trials.
- Knowledge of ICH-GCP guidelines and regulatory requirements.
- Strong organizational skills, attention to detail, and ability to work both independently and within a team.
- Willingness to travel regionally (approx. 50%-75%).
- 1–5 years of experience in a CRA role, or at least 1 year in CRA role with 1-5 years in-house CRA, or Clinical Trial Assistant role.
- Someone who has supported Phase I or oncology studies or is eager to grow into that space with guidance.
- Strong foundational knowledge of GCP and site management but still gaining independence in full-site oversight.
Compensation and Benefits:
The expected base salary range for this position is $60,000 - $90,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise align strongly with the requirements of the role.
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.
Recommended Jobs
Locum Neonatal Nurse Practitioner
Now Hiring: Experienced Neonatal NPs & PAs for High-Census Level 3 NICU in Coastal NJ! We are seeking experienced Neonatal Nurse Practitioner (NNPs) and Physician Assistants (PAs) with Neonatal ex…
Sales Consultant
NO AUTOMOTIVE EXPERIENCE NECESSARY! Earning potential can easily exceed $100,000 a year. Planet Honda is the #1 Honda Dealer in NJ and Top 10 in the Country. Our Sales Consultants receive top level …
Coffee Service Route Sales Specialist
Wake up, roll out, and serve great coffee all day Picture this: It’s 7:00 am and you’re loading your truck for a smooth run across your assigned stops. You’re the face of our coffee and tea program…
Guidewire Developer
Role: Guidewire Developer Location - Jersey City (Remote) Position Type: Contract Skill Requirements • Strong expertise in guidewire policy center and guidewire claim center configurati…
Delivery Job
Job Description Job Description Job Description: We are seeking a reliable and motivated Delivery Driver to join our team. The ideal candidate will be responsible for delivering goods safely…
MEDICAL ASSISTANT
Job Description Job Description A medical assistant performs both administrative and clinical tasks. Administratively- manage appointment scheduling, medical records,confirming appointments, p…
Neuroscience Account Representative
Do you have a noticeable passion for results? You are bold, empathetic, and very resourceful, especially when results are at stake. You have what it takes: a competitive drive, a strategic mind…
Remote Insurance Broker
Spieldenner Financial Group is seeking independent, motivated, career-minded individuals to join our Mortgage Protection team. Our team members help American families protect their largest asset: th…
Boxing / Heavy Bag Instructor
The Boxing / Heavy Bag Instructor at Fitometry Health Club is responsible for instructing and guiding individuals of all fitness levels in the discipline of boxing. This versatile role encompasses bo…
BAS/HVAC Controls Technician
Job Details: BAS / HVAC Controls Technician HVAC Controls - BAS – HVAC- Building Automation Systems- DDC Controls Our New Jersey-based full service mechanical contracting/BAS/HVAC Contro…