Assistant Director, College of Medicine Clinical Trials Office

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POSITION SPECIFICS The Penn State College of Medicine Clinical Trials Office (COM CTO), in Hershey, PA, is dedicated to assisting in advancing clinical research through a commitment to excellence in support, compliance, and collaboration. We strive to ensure billing compliance, develop accurate and fair budgets, and provide robust support for the institution’s Clinical Research Management System (CRMS).

Through its oversight of clinical research, the COM CTO ensures that clinical research studies are conducted with integrity, efficiency, and to the highest standards, ultimately contributing to innovative healthcare solutions and improved patient outcomes. By fostering strong partnerships with sponsors and CROs, the COM CTO creates new opportunities that enhance Penn State College of Medicine's ability to have early access to research clinical studies for cutting-edge, novel therapies.

Through

education:

al events, workshops, and workforce development initiatives, the COM CTO empowers our study teams to excel in their research endeavors. The Assistant Director, College of Medicine Clinical Trials Office (CTO Assistant Director) will support the CTO Director who provides management support to the senior management of the Penn State College of Medicine clinical research community including areas such as strategic planning, project management, risk management, compliance assurance, finance/budget, workforce development and planning, facilities/space planning, and information technology.

The CTO Assistant Director will be delegated to lead these activities as well as supervise employees responsible for these areas who are employed within the COM CTO. Primary duties include: Program Leadership and Supervision • Lead the Human Research Quality Assurance (HRQA) program.

• Prepare and submit reports as required to the CTO Director and the Executive Director of the Human Research Protection Program for findings identified through clinical trial reviews.

Make recommendations based on identified gaps in regulatory compliance issues discovered through these reviews.

• Lead reviews of complaints and/or allegations of non-compliance.
• Directly supervise HRQA staff and assigned CTO work units, coordinate workloads, and oversee performance management.
• Review reports written by HRQA staff for directed reviews and routine reviews with reportable findings.
• Mentor, train, and foster professional development of staff.
• Coordinate with Research Integrity and IRB units at University Park to align on compliance and registry

requirements:

Regulatory Compliance and Auditing • Conduct routine and directed compliance audits of clinical trials.

• Draft audit reports, recommend corrective actions, and monitor implementation.
• Develop and review policies and SOPs, and collaborate with the Research Integrity Program to establish institutional standards.
• Provide subject matter expertise across the organization in best clinical research practices.
• Oversee the develop of monitoring plans for IND/IDE and multi-site investigator-initiated trials.

Education:

and Training • Develop and deliver

education:

al programs for faculty, investigators, and research staff.

• Disseminate new knowledge and best practices through various platforms including but not limited to monthly Research Operations and Administrative Rounds, and staff meetings.
• Lead workshops,

skills:

sessions, and one-on-one training.

• Maintain institutional resources such as the Clinical Research Guidebook and coordinate ongoing updates.
• Engage in one-on-one meetings with both faculty and research staff from other departments outside the CTO, as needed, to provide more in-depth generalized clinical research training, as well as project-specific guidance.

Regulatory Representation and Oversight • Review all Investigational New Drug (IND) and Investigational Device Exemption (IDE) submission to the FDA. Serve as the primary institutional liaison to the FDA for IND/IDE submissions, ensuring all communications, responses, and queries are accurate, compliant with institutional policies, and supportive of investigators throughout the regulatory process.

• Advise and provide guidance to IRB regarding applicability of FDA regulations through their Ancillary Review process.
• Provide institutional guidance for high-risk FDA-regulated trials and NIH-mandated trial oversight.
• Serve as the lead Institutional Administrator for ClinicalTrials.gov Protocol Registration System.

Investigator and Study Team Guidance • Provide subject matter expertise in clinical research operations, compliance, and best practices.

• Advise and provide guidance to investigators regarding their role of Sponsor Investigator as defined by the FDA for IND/IDE holders.
• Evaluate and review clinical trials for feasibility and logistics.

Attend protocol feasibility budget meeting(s) and assist in any follow up as needed. Institutional and External Liaison • Communicate and collaborate with the Human Research Protection Program, Office of Research Affairs, College of Medicine Controller’s Office, PSH Finance, Patient Financial Services, PSU Risk Management, Legal counsel, PSU Research Integrity Program, other units under the Vice Dean of Research and Graduate Studies, and clinical departments as needed to ensure compliance with clinical research regulations and operations.

• Provide guidance to external committees and senior leaders across the university and health system.

Strategic and Operational Management • Develop and manage operational and personnel budgets for assigned units.

• Partner with CTO leadership to implement strategic planning and align HRQA objectives with broader research goals.
• Promote a culture of continuous improvement and quality advancement.

This position can be on-site or hybrid. On-site will be required for audits and inspections.

Preferred Qualifications:

Extensive knowledge of federal regulations, policies, and ICH GCP as it relates to monitoring and auditing and/or providing guidance as content expert ACRP, SoCRA, or PRIM&R certification (or will obtain within 6 months) Clinical research study coordination

experience:

Clinical research auditing and/or monitoring Clinical background (e.g., RN, LPN, EMT-P, RT, Pharmacist, etc.) strongly preferred Well-qualified candidates will have

experience:

in at least one of the following areas: Training (onboarding and ongoing) of clinical research professionals Registration and results reporting in ClinicalTrials.gov Protocol Registration System (PRS) Preparation and/or submission of documents to FDA MINIMUM

EDUCATION:

, WORK:

EXPERIENCE:

& REQUIRED CERTIFICATIONS Bachelor's Degree 8+ years of relevant

experience:

, includes 3+ years of supervisory

experience:

; or an equivalent combination of

education:

and

experience:

accepted Required Certifications: None BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of background check(s) in accordance with University policies. Penn State does not sponsor or take over sponsorship of a staff employment Visa. Applicants must be authorized to work in the U.S.

SALARY &:

BENEFITS:

The salary range for this position, including all possible grades, is $97,100.00 - $145,700.00. Salary Structure - Information on Penn State's salary structure Penn State provides a competitive

benefits:

package for full-time employees designed to support both personal and professional well-being. In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time. One of the standout

benefits:

is the generous 75% tuition discount, available to employees as well as eligible spouses and children. For more detailed information, please visit our

Benefits:

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