Sr Regulatory Program Manager

• Temple University's Lewis Katz School of Medicine is searching for a Sr. Regulatory Program Manager!

Salary Grade: T27

• Click here to view some university guidelines regarding internal transfers, lateral moves and promotions.
• Salary Range: $70,000 - $80,000

A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant’s education and experience, all relevant internal equity considerations, department budget, and funding source.

Become a part of the Temple family and you will have access to the following:

Full medical, dental, vision coverage

Paid Time Off

9 Federally Observed Paid Holidays

3 Personal Days

Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE

A generous retirement plan and so much more!

Position Summary:

This position is responsible for managing and coordinating regulatory activities related to clinical research studies under the LKSOM, including the preparation and submission of regulatory documents to IRBs, sponsors, and other governing bodies. The role involves supervision and training of regulatory staff, maintaining compliance with institutional and federal regulations, and supporting quality assurance initiatives. The position serves as a primary liaison between investigators, sponsors, and regulatory agencies to ensure smooth study conduct from initiation through closeout. Additionally, the role includes oversight of electronic document management systems, participation in audits and inspections, and active involvement in departmental process improvements and staff education as well as onsite clinical research suite oversight.

Job Details:

* This position requires the following background checks: criminal history review

Required Education And Experience:

• Bachelor's Degree and 5 years of relevant experience
• An equivalent combination of education and experience may be considered

Required Skills And Abilities:

• Prior experience with IRB submissions both local and central
• Prior research experience in a healthcare setting
• Strong leadership, management, and team-building skills.
• Excellent communication and interpersonal skills. Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants.
• Ability to operate all standard office equipment/software including MS office.
• Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines.

Essential Duties:

• Interviewing, Supervision and training of Regulatory Coordinators
• Ensure all clinical research staff and investigators undergo required trainings, provide support and guidance as needed
• Interviewing of other research staff candidates as requested
• Prepares and processes all regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events. This includes working with different central and single IRBs and completing submissions/downloading from their websites; coordinating between Temple IRB and the sponsor-selected single IRBs.
• Perform on-site assessments to identify gaps in compliance and implement corrective actions where needed·
• Prepares sponsor-required regulatory documents (site questionnaires, regulatory document submissions, regulatory correspondence etc.) and prepares internal data collection documents and study posting for clinics, physician and websites
• Maintaining IRB and consents and staff in OnCore CTMS system
• Oversite of Florence eBinders (when being used), including maintaining records, staff training, physician training and education. Liaison with Florence support team and TUHS leadership as needed to troubleshoot problems.
• Create study binders for LKSOM research teams and provide ongoing assistance and support when needed. Assign roles to new hires.
• Responsible for writing, updating and maintaining the department’s SOPs/Guidance Documents and procedures related to clinical research with research leadership
• Create/manage a library of forms and templates to upload to LKSOM Research Administration website for research teams to utilize
• Create guidance materials for clinical investigators related to performing clinical research at Temple.
• Participates in site visits, such as site initiation, monitoring, audit and close out visits.
• Work with multiple vendor platforms
• Participate in study team meetings, other required group meetings
• Oversee the maintenance of internal documents related to study document organization; maintains study related documents; obtains current C.V.s, licenses, and certification on staff and laboratories; obtains signatures on study documents and for written communications to study patients.
• Coordinates New Employee Orientation/onboarding meetings and other research educational activities.
• Update onboarding materials as appropriate
• Meet regularly with new hires (weekly, then biweekly, then monthly until they are able to work independently)/ review their work to ensure it is being done correctly per the regulations.
• Initiation Performance Improvement/Quality Improvement activities in the department.
• Responsible for the conduct of Audits and Inspections
• Work with Biosafety Committee to streamline processes, completing review requests, preparing application submissions
• Download of safety reports and PI review of the reports.
• Participates in the coordination of active Phase I-IV clinical trials. Interact with sponsors, PIs, research clinical staff as well as Data and Safety Monitors.
• Prepares and processes all required regulatory documentation for pharmaceutical companies, CROs, the NCI, FDA, etc.
• Resolves regulatory and data queries as required by communicating with the PIs, clinical research nurses, sponsors, IRB(s).
• Interacts with IRB, study sponsors and site PI’s to implement marketing goals for clinical trials along with the research leadership
• Assists in the development of Investigator initiated protocols, assists with IND applications and annual reports, development/maintenance of study specific case report forms and source document tools
• Trains research personnel on consent process/forms and the regulatory processes and regulatory documents
• Perform staff assessments to identify gaps in compliance and implement corrective actions where needed
• Ensures research data is logical and appropriate, manages and directs the completion of research documents
• Provide manager-on-duty on-site oversight of suite operations; escalate to research leadership as appropriate.
• Performs other duties as assigned

Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.

Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.

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You may request a copy of the report by calling Temple University’s Department of Public Safety at 215-204-7900.