Under the direct supervision of the TRIO-US Clinical Trial Manager (CTM), the Monitor for TRIO-US CRO (Monitor) is responsible for oversight and monitoring of assigned studies of all contracted research services of assigned clinical trials. S/He works collaboratively with the CTM, COO, academic faculty and outside partners to monitor clinical research studies under the TRIO-US CRO supported by, but not limited to, pharmaceutical companies, private foundations, and academic medical centers.
The Monitor will ensure the trial(s) is conducted, recorded, and reported in accordance with the protocol, TRIO-US Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), Code of Federal Regulations (CFR), International Conference of Harmonization (ICH), institutional review board (IRB) requirements, and the applicable regulatory requirement(s) ensuring study subject safety, proper use and organization of investigational medicinal product (IMP), and data integrity. The Monitor will serve as the main line of communication between the CRC partner(s) and the site(s).
In accordance with an agreed upon data and safety monitoring plan (DSMP), the Monitor will conduct monitor and quality assurance review.
Monitoring duties include but are not limited to the following:
Oversee the progress of assigned clinical trials and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), IRB requirements, and the applicable regulatory requirement(s) to ensure study subject safety, proper use and management of investigational medicinal product, and data integrity. The Monitor(s) ensures the trial is conducted and documented properly through a combination of remote data review and on-site monitoring visits including a site initiation visit (SIV) interim monitoring visits (IMV) for source data verification (SDV) regulatory compliance and IMP accountability and management, and close out visits. They are to act as the main line of communication between the sponsor and the investigator. Overseeing and performing monitoring of clinical trial(s). Monitoring includes the following:
Verifying the investigator has adequate qualifications and resources and they remain adequate throughout the trial period. Verifying the site facilities, including laboratories, equipment, and staff, are adequate to execute the trial safely and properly; and resources remain adequate throughout the trial period. This includes reviewing calibration and maintenance records as well as meeting
Ensuring the investigator receives the current Investigator's Brochure (IB), protocol, protocol related documents (e.g. letters of clarification or newsletters), and all supplies needed to conduct the trial properly and in compliance with the applicable regulatory requirements.
Storage conditions are acceptable
IMP(s) supplies are sufficient throughout the trial
IMP(s) are dispense and administered only to subjects eligible to receive it according to the protocol and at the protocol specified dose(s)
Subjects are provided with instructions on proper use, handling, storage, and returning the IMP(s). (v) The controlled receipt and accounting of IMP(s) use, and return of the IMP(s) at the trial sites, through documentation
The disposition of unused IMP(s) at the trial sites complies with applicable regulatory requirement(s) and is in accordance with the sponsor proscribed instructions.
Compliance and Progress
Verifying the investigator and the investigator's designee(s) performing the specified trial functions have been properly trained in GCP, the study protocol, and other appropriate regulatory requirements. Ensuring the investigator has not delegated protocol related functions to unauthorized individuals. Ensuring the investigator and/or designee(s) are performing study related functions in accordance with the protocol and any other agreement between the sponsor and the investigator/institution. Verifying the investigator is enrolling only eligible subjects; that written informed consent was obtained before prior to any study-related procedures be subject's participation in the trial and each time information is updated. Verifying that source documents and other trial records are accurate, complete, kept up-to-date and maintained. Ensuring site regulatory binder is maintained appropriately and all IRB requirements are fulfilled. Verifying that all safety information is adequately collected, received, reviewed, reported and maintained, as appropriate, including Serious Adverse Event reports, reference safety information and Informed Consent documents.
Case Report Forms (CRFs) and Source Data Verification
TRIO-US will verify the CRFs are:
Consistent with corresponding source documents
Completed by only authorized persons; and
Corrections are timely and signed, dated and backed by accurate source documents.
The Monitor will provide written reports of completed visits or meetings. These reports include monitor and audit reports and meeting minutes.
The Monitor develops and maintains productive relationships with the research and clinical community and other important stakeholders in TRIO-US, TRIO-Global, UCLA, and external partners. S/He supports high quality research, customer service excellence and fiscal responsibility while serving as a direct link between the clinical research site staff, TRIO-US and sponsors. The Monitor practices a high level of integrity and honesty in maintaining confidentiality and performs other related duties as assigned or requested.
Bachelor’s degree or high school diploma or GED with nursing license.
Five years of experience in oncology clinical research and a management with a focus on early phase clinical trials and operations
Experience with monitoring and quality control processes.
Working knowledge of policies and procedures that govern clinical research, including but not limited to FDA regulations, Good Clinical Practices, Health Insurance Portability and Accountability Act (HIPAA).
Skills & Abilities
· Knowledge and experience in managing clinical trials.
· Knowledge of regulatory guidelines and requirements for the conduct of clinical trials and research subject protection.
· Knowledge and experience in the clinical research environment.
· Skilled in communicating effectively, facilitating group processes and training staff; preparing data analysis
· Ability to establish and maintain effective and productive working relationships with all employees, public and private organizations
· Ability to work under pressure and to maintain efficiency and composure
· Exceptional customer service and interpersonal skills
· Good judgment and decision-making abilities
· Excellent verbal and written communication skills
· Talent for leading and facilitating group and team meetings
· Attention to detail and analytical skills
· Ability to work independently within a defined strategy
· Comfortable in handling challenging situations that may involve adverse outcomes
· Strong record of leadership, project management, and collaboration
· Demonstrated analytic and computer skills including use of statistical control charts with strong writing, problem solving and communication skills
The Translational Research in Oncology-US, Network (TRIO-US) is an organization with a long-standing history of providing innovative cancer research in the community, beyond the walls of large academic medical centers and big cities. TRIO-US is a site management organization (SMO) of committed oncologists across the United States interested in offering their patients opportunities to participate in research of novel cancer therapies, while staying close to home. TRIO-US has more than 14 participating community oncology practices from California to Florida
We base our research efforts on therapies targeted to cancer to minimize side effects and focus more directly on the cancer. We work to get early phase studies to patients in their communities to reduce the burden on traveling to large cities or academic medical centers. This helps not only the patients but allows for the faster progress of cancer research by quickly reaching more people. It also allows for us to offer research in a more inclusive way, by extending research to communities that may be underserved or underrepresented in clinical trials, offering potentially better cancer care options.
It is because of th...e participation of the thousands of patients, their committed clinicians and support systems that TRIO-US has been able to develop and offer important research that led to many new therapies for breast, kidney, lung, and colorectal cancers.