About This Role
Supporting Principal Investigators by managing clinical research projects is the core of this senior role in research administration. The Senior Clinical Research Coordinator gathers patient data according to study protocols and provides complex administrative support to ensure compliance with regulations.
Responsibilities
- Apply knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities
- Supervise and assist with the preparation and submission of all IRB and Regulatory Documents to obtain final approval, under the direction of the PI
- Draft various communications with the Sponsor
- Attend and participate in the Investigator meeting
- Review goals and requirements of any new protocols and coordinate study initiation
- Identify and recruit clinical research subjects for participation in studies, collect data, and monitor enrollment goals
- Assess staffing needs based upon current research activity and implement changes in staffing as needed
- Participate in protocol initiation visits
- Plan and design source documentation for protocol
- Develop assessment tools per protocol for use in clinical research and teach research team and hospital personnel how to use them as allowed per medical practice
- Develop procedures for laboratory collection and storage
- Assist in processing and shipping lab specimens; retrieve and/or send identified research specimens certified if indicated as per regulations
- Maintain accurate source documentation and appropriate forms as per protocol including participant records, drug documentation, and reconciling study drug accountability
- Monitor documentation for quality and accuracy
- Conduct reviews of ongoing studies and oversee quality assurance on ongoing protocols; maintain a productive working relationship with the study monitor
- Precept new clinical research staff and educate research staff regarding scientific aspects of studies
- Provide performance management for staff under the direction of the PI
- Assess communication processes within the Department and/or services required by the protocol
- Elicit relevant data from sources outside of the hospital
- Assist PI in budget development; monitor ledgers
- Assist in processing and shipping lab specimens efficiently and cost effectively
- Maintain supply inventory and equipment; ensure return of test article/clinical supplies; maintain regulatory standards
- Identify and recruit clinical research subjects; monitor enrollment goals and modify recruitment strategies, as necessary
- Mentor all clinical research personnel regarding enrollment/recruitment
