Scientific Program Manager Vpp

Develops and assists staff implement policies and procedures related to the organizations scientific programs.

• Provide information and support needed for each protocol that includes: o Protocol/IC development: writing and revision assistance Statistical support o Scientific Review submission requirements o IRB submission requirements o FDA/ Regulatory Affairs submission requirements o Safety Monitoring Committee/DSMB oversight o Multi-Site establishment/monitoring o Radiation safety requirements o Ethics clearance o Technology development/ Clinical Trial Agreement (CTA) establishment o Biotechnology Activities/RAC/IBC o Data elements to be collected/identify database used/Third Party Data transmission

Collects analyzes and creates scientific program information.

• Orchestrate meetings with Principal Investigators (PIs) and other key research staff to identify the level of support needed and create timelines and manage protocol start-up logistics including facilitating early discussions among investigators research teams and statisticians to ensure processes are mutually understood and acceptable.

Coordinates workshops and reports their outcomes.

• Work directly with PIs and medical writers on the design plan production and revision of study documents including applying clinical and regulatory knowledge to the review of protocol and informed consent documents including assisting with the writing/revision of clinical research protocols and informed consent forms (ICFs) and completing standard wording for regulatory sections in new protocols and ensuring consistency within protocol and between protocol and ICF.

Evaluates current scientific programs and determines if changes need to be made.

• Review packages for IRB submissions such as initial reviews continuing reviews amendments and problem reports for compliance with regulatory and institution requirements format documents appropriately and ensure the action is complete prior to submission.

Assists with analyzing current scientific programs and developing and proposing new initiatives.

• Monitor key ethical and legal issues related to protection of research participants adherence to policies for the appropriate use of biospecimens and adherence to federal and state regulations surrounding the collection storage dissemination and use of biospecimens.

Collaborates with management and prepares reports to keep them updated on new and ongoing programs and activities.

• Assist research staff in navigating requirements for protocol approval; completes submissions to approving bodies (e.g. scientific review requirements for protocol approval; completes submissions to approving bodies serving as the Point-of-Contact(POC) for the
• Investigator; coordinate with PIs to ensure stipulations are addressed appropriately and on-time; and tracks the required approvals.

Coordinates staff responsible for developing installing and maintaining scientific programs.

• Provide advice and assistance in troubleshooting human subjects protection issues.

Analyzes current policies and procedures and suggests and develops improvements.

• Work closely with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submission for both initial reviews and amendments and shares relevant information with PN/PDP team members.

Assists in preparing and developing future strategic plans.

• Ensure protocol design safety issues are identified early.

Prepares and provides educational materials to staff.

• Ensure required oversight is initiated and outlined in the protocol.

Works closely with management to develop new initiatives that further scientific research.

• Collaborate and communicate with other divisions and individuals to identify the regulatory guidelines and required timelines for Food and Drug Administration (FDA) requisite activities.

Uses scientific expertise to review grant proposals and Interacts with potential grantees to obtain additional information.

• Participate in the preparation of reports for appropriate regulatory and monitoring bodies/boards.
• Prepare program actions that do not go to the IRB such as data sharing plans reliance agreements and technology transfer agreements.- Disseminate expertise and best practices related to Human Protections in clinical research through presentations publications and/or interactions with colleagues.
• Coordinate with investigators to ensure stipulations are appropriately addressed in a timely manner.
• Prepare and compile data from ongoing protocols and drafting annual continuing review reports for distribution to appropriate regulatory agencies
• Prepare all documents for amendment submissions to the IRB including the changes to the protocol and cover memo detailing the changes
• Provide assistance for all aspects of the protocol lifecycle including initial IND submission IRB submission of protocols continuing review applications protocol amendments annual reports to other regulatory bodies such as OBA and IBC and protocol inactivation with IRB and FDA.
• Complete standard forms in Iris for IRB submission and standard forms for submissions to other regulatory bodies such as the FDAIBC and Safety Monitoring Committee.
• Work with the Investigator to ensure DSMB SMC or other safety reviews are completed in a timely manner
• Assist investigators with preparation for FDA audits.
• Assist investigators with drafting and submitting memos to review committees describing requests and actions.
• Track clinical staff training for IRB-approved protocols educating clinical staff about human research protection and FDA policy updates assisting investigators with incorporating suggested changes to protocol documents in response to FDA comments and stipulations.
• Assist investigators with maintaining protocol applications within the protocol management database system.
• Assist investigators with program actions that do not go to the IRB such as data sharing plans Requests for Determination and reliance agreements (OHSRP) and technology transfer agreements (Office of Technology Transfer). 1
• Assist investigators with communication among parties staying on schedule and meeting deadlines associated with clinical program/protocol management. 2
• Track clinical staff training for IRB-approved protocols educate clinical staff about human research protection policy updates. 3