Senior Clinical Research Associate-Contractor
About The Position
SystImmune is seeking an experienced Senior Clinical Research Associate (CRA) Contractor to support the execution and oversight of clinical trials. The Senior CRA Contractor will be responsible for managing assigned clinical study sites to ensure patient safety, protocol compliance, and data integrity in accordance with ICH-GCP guidelines, applicable regulations, and study requirements. The ideal candidate is a highly organized, self-motivated clinical operations professional with strong oncology monitoring experience who can work independently while collaborating effectively with cross-functional teams and external vendors.
Requirements
- 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.
- Ability to travel approximately 50–75% as required.
Nice To Haves
- Experience supporting early-phase oncology studies is highly preferred.
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.
- Monitor site enrollment activities and proactively identify and escalate recruitment challenges and mitigation strategies.
- Perform remote and on-site monitoring to assess patient safety, protocol compliance, source data verification, and data quality.
- Partner with site personnel to ensure timely and accurate data entry and prompt resolution of data queries.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
