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 highly skilled and motivated
Senior Clinical Research Associate to oversee and support the execution of oncology clinical trials. This role combines hands-on site monitoring with strategic project management responsibilities for approximately 10 clinical trial sites participating in a trial. The ideal candidate will be experienced in clinical trial site monitoring and management, operations and cross-functional coordination to execute clinical trials, with a strong understanding of regulatory requirements and oncology research.
Responsibilities: Clinical Monitoring & Site Oversight:
- Conduct Site Evaluation, Initiation, Interim Monitoring, and Close-Out Visits.
- Ensure site compliance with ICH-GCP, protocol, and regulatory requirements.
- Monitor patient safety, data quality, and recruitment progress via EDC and direct site communication
- Manage patient recruitment strategies, proactively identifying barriers to recruitment while proposing solutions (i.e., study-site webinars, newsletters or other potential creative solutions)
- Continually evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations and escalate issues as appropriate with proposed solution.
- Liaise with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries
- Manage the progress of assigned studies and ensure awareness of regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Manage investigational product (IP) inventory, reconciliation, and protocol adherence.
Project Management & Study Execution:
- Lead planning and execution of clinical trial sites from initial outreach and feasibility to close-out.
- Develop study plans and documents (Monitoring Plan, Cohort Management Plan, etc.).
- Coordinate with CROs, vendors, and internal teams to ensure timely delivery of study materials and milestones.
- Identify and mitigate project risks associated with site performance, manage timelines, and coordinate site payments in alignment with budgets.
Stakeholder Communication & Documentation:
- Maintain essential documents and Trial Master File (TMF).
- Liaise with investigators and site staff to resolve queries and ensure timely and high-quality data entry.
- Support with site submission of regulatory documents; database lock and final reporting.
- Participate in cross functional team meetings and provide updates to stakeholders.
Process Improvement & SOP Development:
- Contribute to internal SOPs and process optimization initiatives.
- Support training and mentoring of junior staff as needed.
Requirements: - Bachelor’s degree in Life Sciences, Nursing, or related field.
- Minimum 5 years of experience in clinical trial monitoring and/or project management, preferably in oncology.
- Strong knowledge of GCP, ICH guidelines, and regulatory requirements.
- Proficiency in Microsoft Office and clinical trial systems (CTMS, EDC, eTMF). Experience in Veeva preferred.
- Excellent organizational, communication, and leadership skills.
- Ability to travel up to 50% depending on project needs.
Preferred qualifications:
- Master’s degree or clinical research certification (ACRP, SOCRA).
- Experience in Sponsor and/or CRO environments.
- Prior experience with multi-center oncology trials.
- Familiarity with electronic data capture and clinical trial management platforms.
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.
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 exceeds 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.
Job Tags
Full time, Interim role, Work at office,