Clinical Research Monitoring (CRA)
Background. The Division of Intramural Research (DIR) of the National Heart Lung and Blood Institute (NHLBI) possess a strong clinical research program whose mission is to advance the detection, diagnosis, and treatment of cardiovascular, pulmonary, and hematologic-related diseases in humans. This mission entails administration of clinical trials that can later be translated into broad clinical practice, thus enabling advances in basic science to impact public health. The DIR takes full advantage of its basic and translational research environment in which patients can be studied intensively to gain valuable pathophysiologic insights coupled with basic, bench research to uncover fundamental mechanisms and functions.
The DIR’s clinical protocol portfolio is comprised of more than 140 active Phase 0/I/II/III interventional therapy, observational/natural history, and cardiovascular imaging protocols. Approximately 30% of these protocols involve Investigational New Drug (IND) or Investigational Device Exceptions (IDE), the majority of which are held by DIR Principal Investigators.
Task 1. Clinical Research Monitors. Contractor shall employ a team of 6 fulltime, qualified Clinical Research Monitors (aka. Monitors) to meet the research monitoring needs of the DIR’s clinical research program. Under the direction of the OCD, Contractor shall assign Monitors to work on specific protocols, research areas, and/or research teams. Monitors shall exhibit the highest level of professionalism in their work and interactions with Federal government employees and other contractor staff. Monitors shall work collaboratively with clinical research staff to meet protocol objectives and further the DIR’s mission. Under the direction of the OCD and in accordance with DIR standard operating procedures, Monitors shall be responsible for all monitoring activities for each protocol. Such activities include but are not limited to the following:
- Provide comprehensive research monitoring for single-site and multi-site clinical research protocols
- Develop comprehensive research monitoring plans for new protocols. Regularly update plans for each protocol as needed.
- Plan, coordinate, and execute in-person visits to sites (i.e. site initiation visits, routine monitoring visits, and close-out visits)
- Assure adherence to International Commission on Harmonization (ICH), Good Clinical Practices (GCP), and Code of Federal Regulations (CFR)
- Assure compliance with institutional Standard Operating Procedures (SOPs) and policies, protocol requirements, and institutional reporting requirements
- Identify and inform Principal Investigators and protocol sponsors of concerns related to quality of protocol conduct. Provide concrete solutions to concerns/problems identified, and assist in the execution of such solutions.
- Perform regular Quality Control and Quality Assurance of clinical data uploaded to a variety of databases
- Assure study time points and regulatory reporting timelines are met
- Track trends in monitoring findings in order to identify potential global issues and work with OCD to educate clinical research staff accordingly
- Maintain awareness of all developments in the field of clinical research including application of new technologies by reading related literature, attending professional seminars, etc.
- Perform other tasks as assigned by OCD
The OCD will ensure adequate space is provided for Monitor staff to perform their assigned duties both on NIH main campus in Bethesda, MD and at partnering sites.