The clinical research associate/monitor performs and coordinates all aspects of the clinical monitoring and site management processes in accordance with the Clinical Monitoring Plan, ICH/GCP, FDA guidelines, local and federal regulatory requirements and Standard Operating Procedures. The monitor is responsible for multiple clinical sites and must be able to work both independently and in a team environment.
· Ensure that the conduct of the trial(s) are in compliance with the currently approved protocol/amendment(s), with ICH current GCP, FDA, CFR along with other applicable Sponsor and regulatory requirements.
· Conduct on-site clinical monitoring that includes but is not limited to; protocol training as required, trial document review, ensuring accurate data acquisition and recording, monitoring adverse events, concomitant medications and verifies they are reported in accordance with the protocol on the electronic Case Report Form (eCRF), verification of subject data, ensuring adherence to the clinical protocol, site and Sponsor SOPs,
· Monitor and complete regular investigational product accountability, verification of product shipping/storage conditions.
· Verify and ensure that the rights and well-being of the human subjects enrolled in the clinical trials are protected and that the reported trial data are accurate, complete, and verifiable from source documents.
· Complete monitoring reports and written documentation adhering to the stated requirements and expected timelines in a timely fashion.
· Assists in establishing and maintaining the Trial Master File (TMF) independently and as documents are received from Study Sites to ensure that required documentation is accessible, searchable, and retained in accordance with quality and regulatory requirements.
· Work effectively and efficiently as part of the clinical monitoring team and act as the Sponsor’s liaison to resolve site related issues quickly and effectively.
· Maintain written trial documentation and/or email communications as well as telephone communication with assigned clinical sites.
· Participate in reviewing protocols, amendments, investigator brochures, Informed Consent Forms (ICFs) and CFRs and facilitate Institutional Review Board (IRB) submission, queries, and approval.
· Identify and report potential clinical trial risks and any significant issues impacting the clinical trial. Work with management team to develop and execute an appropriate corrective course of action for risk mitigation.
· Utilize effective tools for management, monitoring, and reporting on status of clinical sites.
· Provides oversight of clinical studies to ensure adverse events are identified, tracked, and reviewed with appropriate responses developed, documented per procedure, and communicated, as required.
· Monitor and track regulatory review progress for assigned clinical sites, including but not limited to Scientific Committee Review, IRB/EC, particularly tracking submission/approval, continuing review reports, DMC/Safety reports and other study documentation as required.
· Supports input to data monitoring committee (DMC), and investigator meetings, as requested.
· Conduct closeout site visits, including reviewing record retention requirements, investigational product reconciliation and securing and reviewing investigator’s final report.
· A degree in health care, biological sciences, or equivalent along with 3 years in the medical device and/or pharmaceutical environment monitoring clinical sites and working with clinical professionals within a team.
· Must possess 3 years of on-site monitoring experience including Electronic Data Capture (EDC) studies.
· Must have a minimum of 2 years oncology experience. Experience in solid tumors, interventional oncology and/or radiation oncology preferred.
· Excellent oral, written, analytical, and interpersonal skills along with solid computer tracking capabilities to manage and meet project goals within expected timelines and study metrics.
· Strong attention to detail.
· Effective and proven clinical monitoring skills.
· Demonstrated understanding of medical/therapeutic area knowledge and medical terminology.
· Excellent understanding and demonstrated application of GCP and applicable SOP’s.
· Effective organizational and time management skills.
· Proven flexibility and adaptability, willingness to travel 75-85%.
· Ability to work independently as required.
· Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software.