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To manage and support clinical trial regulatory activities for the Pediatric Department, Clinical Research Services. Act as back-up study coordinator for studies as appropriate.
This is a specified term position.

Duties to include:

• Take primary responsibility in collaboration with study lead coordinator to complete regulatory activities to open new clinical trials.

• Serve as a resource and support to study coordinators for regulatory activities required to maintain and close clinical trials.

• Coordinate specific aspects of external review and internal processes. Specifically, oversee the preparation and submission of the appropriate Human Subjects Review forms and application materials to the Institutional Review Board (IRB-01), and central IRB entities. Collaborate with study-specific coordinator to prepare consent forms for research protocols and local and central IRB submissions.

• Prepare and submit application forms and serve as liaison to the Clinical Research Unit (CRU), the Pharmacy and Therapeutics Committee, the Medical Radiation Protection Committee, the Protocol Review and Monitoring Committee, Joint Office of Compliance, Nursing Research Committee, Pathology Committee, and other review committees as necessary. 

• Support the primary study coordinator(s) as needed on additional regulatory tasks (such as annual reviews, modifications, Adverse Events, Safety Reports and other reportable events to IRB).

• Coordinate the regulatory process and document preparation used in the implementation of clinical trials.

• Serve as liaison to clinicians, research investigators, data managers, nursing services staff, pharmacists and medical personnel to ensure sufficient cooperation among participating stakeholders for each clinical research study. Assist in the execution, administration and maintenance of protocols and clinical studies. Provide input into descriptions of research procedures.

• Coordinate specific aspects of external review and align with internal processes. Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions and assist with on-site audits when needed.

• Monitor compliance with regulatory guidelines and ensure proper maintenance of documents. Work with primary coordinator to develop regulatory files and binders, assist as requested in maintenance.

• Assist primary study coordinator(s) with monitoring and auditing issues that relate to regulatory activities, when needed.  

• Enter data for the evaluation of clinical research metrics through our OnCore database as it relates to the initial regulatory review and submission process.

• Assist study staff with compliance of policies and procedures as they relate to regulatory activities.

• Prepare and deliver basic content that enhances knowledge of and compliance with internal and external standards and regulations.

• Attend all appropriate meetings as assigned: this will include but is not limited to with internal and external groups to provide reporting of study updates, educational and training meetings, meetings with team leads and supervisors, and meetings with sponsors or CROs.

• Assist in general coordinator activities as required as a back-up coordinator.  These might include study-specific training, assist with preparing for and completing subject visits, data entry, and other study specific tasks as appropriate.