The Semel Institute is seeking an Assistant Clinical Research Coordinator to contribute to the overall operational management of clinical research / trial / study activities from design, set up, conduct, through closeout. In this role you will have responsibility for the coordination of research activities for one or more studies and you’ll recognize and perform necessary tasks to coordinate projects and prioritizes work to meet necessary deadlines. You would also participate in planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP). As the Study Coordinator you will collaborate with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support. Performance of duties and tasks will vary based on the department operations, the type of study and scope of service but general duties include:
Clinical Research Coordination
Coordinate research studies, identify participants according the IRB approved recruitment plan and Completes role-based training. Attend study initiation meetings and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). Complete protocol required training as needed. Provide ongoing communication to all stakeholders to ensure pertinent information is disseminated. Timely response to and resolution of inquiries, both written and verbal, with the appropriate level of information for the request. Maintain a service centered approach for both internal and external customers, ensuring a high level of quality, communication, and support.
Data and Regulatory Management
Assist in developing the study informed consent form(s) and amending the informed consent form(s) as applicable. Prepare and submit site or study-specific regulatory documents. Track and maintain required case histories/ essential documents as defined by FDA CFR and GCP to ensure regulatory compliance. Assist with routine and audits performed by internal review committees and/or external stakeholders. Ensure timely regulatory reporting and thorough documentation. Develops and implements adequate Corrective and Preventative Action (CAPA) plans as needed.
Training and Development
Completes role-based training. Attend study initiation meetings and participate in team and general staff training events (i.e., teleconferences, webcasts, and/or meetings). Complete protocol required training as neededThis position description is not intended to be a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
*Please note that this limited appointment may convert to career
Pay Range: $27.08 – $43.55