Oncology Sr. CRA

Oncology CRA

Oncology CRA - Early Clinical Development• Conducted site monitoring responsibilities for oncology clinical trials, according to Covance Standard Operating Procedures, ICH guidelines and GCP, including pre-study, site initiation, routine monitoring and close-out visits• Assisted with the implementation of project plans related to the clinical monitoring responsibilities• Ensured the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements• Ensured data integrity by careful source document review, query generation and resolution against established data review guidelines on Covance or client data management systems• Ensured site regulatory documents are complete and current throughout the duration of the trial• Ensured that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements• Participated in site feasibility process in addition to obtaining confidentiality agreements between sponsors and sites as mandated by project team

Oncology Research Coordinator for Breast, Phase 1 and Surgical studies at Levine Cancer Institute• Served as the Data Administrator for all NCTN trials at Levine Cancer Institute.• Participated in protocol development of IIR studies.• Served as the key resource to the Principal Investigator, physicians, and research team and acted as the primary liaison with the sponsors to facilitate study initiation, execution, and termination for breast and lung studies.• Coordinated clinical and regulatory document submissions for clinical trial start up, consent development and amendment, protocol amendment, continuing review, closure to accrual, suspension, termination and other reportable regulatory information.• Collaborated on billing and financial activity with Research Finance.• Ensured understanding of project scope, milestones, budgets, and time codes and strive for high-quality, timely, and efficient delivery.• Previously responsible for planning, conducting and reporting all data management in EDC systems• Oversaw daily operations for all aspects of data and specimen management and regulatory compliance for multiple research studies and sites.• Scheduled patient visits, labs, and diagnostic procedures across multiple sites.• Previously responsible for scheduling, handling and shipping samples, cultures, tissues and other specimens as required by study and according to current regulatory guidelines.• Participated in sponsor study start-up and follow-up meetings as appropriate.

• Coordinated all trial activities for multiple myeloma and NSCLC trials • Supported the cancer research program and maintained appropriate and accurate documentation of patient/study participant data• Entered data into EDC systems and resolved queries as appropriate• Maintained kit inventory and shipping supplies for all studies• Assisted with the maintenance of regulatory documents

• Maintained communication with sponsors and regulatory staff • Processed IRB submissions and approvals in OnCore• Maintained regulatory files for Phase 1 trials• Maintained credentials and training documentation for investigators and clinical protocol staff• Completed and submitted NCI registration documents for investigators • QA regulatory documents for audits and monitoring visits

• Followed GCP guidelines to perform various functions for in-house diabetes and hypertension trials• Performed lab collection and processing for clinical research trials • Performed literature reviews• Recruited potential study candidates • Managed patient source binders and patient database• Data management