Senior Clinical Research Associate-Contractor
SystImmune · Princeton, NJ · 1 wk ago
On-siteAnalystFull-time
Position Summary
SystImmune is seeking an experienced Senior Clinical Research Associate (CRA) Contractor to support the execution and oversight of clinical trials.
Responsibilities
- Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and Close-Out Visits (COVs)
- Support site management activities to ensure compliance with protocol requirements, GCP, applicable regulations, and study timelines
- Collaborate with CROs, central laboratories, specialty vendors, and internal stakeholders to support study execution and site readiness
- Verify that investigator sites have completed all regulatory, contractual, and operational requirements prior to site activation and study drug release
- Assist with development and review of study-related documents, including Monitoring Plans, eCRF Completion Guidelines, Data Management Plans, and Safety Management Plans
- Maintain study documentation and ensure completeness of site regulatory files and essential documents
- Identify, document, and follow up on Serious Adverse Events (SAEs) in accordance with study and regulatory requirements
- Support database lock activities, data review, patient profile review, and site closeout activities as needed
- Ensure timely submission and maintenance of essential documents within the Trial Master File (TMF/eTMF)
- Review investigational product accountability, storage conditions, reconciliation activities, and protocol compliance related to investigational product management
- Escalate site issues, risks, and compliance concerns to study leadership in a timely manner
Qualifications
- Bachelor's degree in Life Sciences, Health Sciences, Nursing, or a related field
- Minimum of 5 years of independent oncology monitoring experience in industry-sponsored clinical trials
- Demonstrated experience conducting both on-site and remote monitoring visits
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial conduct requirements
- Experience working with CTMS, EDC, eTMF, and other clinical trial management systems
- Proven ability to build productive relationships with investigators and site personnel
- Excellent written, verbal, organizational, and time management skills
- Ability to manage multiple priorities in a fast-paced clinical development environment
- Experience supporting early-phase oncology studies is highly preferred
Contract Details
- Contract position
- Duration: [6–12 months, with potential extension based on business needs]
- Location: Remote, with required travel to investigator sites
- Hrs: Full-time contract engagement
- Travel: 50–75%
- Compensation: Competitive hourly rate commensurate with experience, qualifications, and geographic location.