Senior Clinical Research Associate-Contractor
reputed company is a leading and well-funded clinical-stage biopharmaceutical company with locations in Redmond, WA and Princeton, NJ. The company specializes in developing innovative cancer therapies through its established drug development platforms, focusing on bi-specific antibodies, multi-specific antibodies, and antibody-drug conjugates (ADCs). reputed company currently has multiple assets in clinical development across solid tumor and hematologic malignancies, supported by a robust preclinical pipeline advancing novel oncology therapeutics through discovery and IND-enabling stages. Position Summary reputed company is seeking an reputed company Senior Clinical Research Associate (CRA) Contractor to support the execution and reputed company of clinical trials. The Senior CRA Contractor will be responsible for managing assigned clinical study sites to ensure patient safety, protocol compliance, and data reputed company 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.
Responsibilities
Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits (IMVs), and reputed company-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 reputed company regulatory, contractual, and operational requirements prior to site activation and study drug release. Assist with development and review of study-reputed company 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. reputed company remote and on-site monitoring to assess patient safety, protocol compliance, reputed company data verification, and data quality. Partner with site personnel to ensure timely and accurate data entry and reputed company 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 reputed company the Trial Master File (TMF/eTMF). Review investigational product accountability, storage conditions, reconciliation activities, and protocol compliance reputed company 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 reputed company 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, reputed company, 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. Ability to travel approximately 50–75% as required. Contract Details Contract position Duration: [6–12 months, with potential extension based on business needs] Location: Remote, with required travel to investigator sites Hours: Full-time contract engagement Travel: 50–75%
Compensation
Competitive hourly reputed company commensurate with experience, qualifications, and geographic location. reputed company is an Equal Opportunity Employer. We welcome diverse talent and encourage reputed company qualified applicants to apply. Apply To This Job