APPLICATION INSTRUCTIONS:

• CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process (https://pennstateoffice365.sharepoint.com/:b:/s/KnowledgeBaseArticlesSharing/EfiwgKReZ4VAjprFZPKWUm0Bq_sU3KzTmERfpryq0esPKQ) . Please do not apply here, apply internally through Workday.

• CURRENT PENN STATE STUDENT (not employed previously at the university) and seeking employment with Penn State, please login to Workday to complete the student application process. (https://pennstateoffice365.sharepoint.com/:b:/s/KnowledgeBaseArticlesSharing/Eeys15Xva4hFokHVtbP1eGIB5i1WFLc-J3k9KHgrFYZ7mg) Please do not apply here, apply internally through Workday.

• If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants (https://hr.psu.edu/sites/hr/files/Application_Process_for_External_Applications_Non-Penn_State_Employees_.pdf) .

JOB DESCRIPTION AND POSITION REQUIREMENTS:

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 educational 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, human resources, 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:

• Directly supervise staff of assigned COM CTO work units. Coordinate team workloads. Provide managerial support for all COM CTO staff. Develop and manage operational and personnel budgets for assigned COM CTO work units, and coordinate with COM CTO financial analyst and Director to manage the overall COM CTO capital, operational, and personnel budgets. Develop COM CTO strategic plan with COM CTO Director.

• Evaluate and review clinical trials for feasibility and logistics. Attend protocol feasibility/budget meeting(s) and assist in any follow up as needed.

• Interview, train, and mentor lower-level COM CTO staff members and teach best practices for oncology and non-oncology clinical research operations and administration. Foster each COM CTO staff members’ personal and professional development goals. Develop and implement performance management strategies and processes that align with office, departmental, and organizational goals. Promote a culture of continuous improvement by encouraging self-assessment and ongoing professional development. Identify training and development needs and create opportunities for professional growth. Monitor performance trends and metrics, providing insights and recommendations for enhancing team effectiveness. Facilitate performance-related discussions and mediate conflicts to maintain a positive and productive work environment. Set clear, measurable performance objectives and expectations for staff in assigned COM CTO work units. Conduct regular performance reviews, provide actionable feedback, and develop performance improvement plans for assigned staff. Align personnel performance appraisal and professional development goals with COM CTO strategic goals. Provide subject matter expertise across the organization in best clinical research practices.

• 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, Clinical Departments, post award Financial Analysts, other units under the Vice Dean of Research and Graduate Studies, and departments as needed to ensure compliance with clinical research regulations, operations, and billing requirements.

• Develop faculty and research staff education programs on specialized research administration topics. Disseminate new knowledge and best practices through various platforms including but not limited to monthly Research Operations and Administrative Rounds, analyst meetings, research skills workshops, and other ad hoc groups. 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.

• Lead office-level process improvement projects and promote a culture of process improvement within the COM CTO. Serve on select committees, task forces, and work groups sponsored by the COM Dean and Vice Dean of Research and Graduate Studies. Maintain business continuity and resilience plan for COM CTO.

This position can be on-site, hybrid, or remote.

Minimum EducationBachelor's Degree

Minimum Experience

• 8+ years of relevant experience, including 3+ years of supervisory experience (Management experience preferred, demonstrable leadership experience will be considered)

• ACRP or SoCRA certification (or will obtain within 6 months) required

• Clinical research study coordination experience required

• 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:

• Clinical research budget development and negotiation

• Clinical research budget and/or finance management

• Medicare coverage analysis

• Training (onboarding and ongoing) of clinical research professionals

• Medical billing and coding

Equivalency

• Or an equivalent combination of education and experience

The following clearances must be successfully completed for this position: 

• Pennsylvania State Police Criminal Background Check 

• Pennsylvania Child Abuse History

• Federal Bureau of Investigation (FBI) Criminal Background Check  

  The Pennsylvania State University is committed to and accountable for advancing diversity, equity, and inclusion in all of its forms. We embrace individual uniqueness, foster a culture of inclusive excellence that supports both broad and specific diversity initiatives, leverage the educational and institutional benefits of diversity, and engage all individuals to help them thrive. We value inclusive excellence as a core strength and an essential element of our public service mission. 

The salary range for this position, including all possible grades is:

$97,100.00 - $145,700.00

Salary Structure (https://hr.psu.edu/current-employee/compensation/staff-salary-grades-and-leveling-matrix) - additional information on Penn State's job and salary structure.

CAMPUS SECURITY CRIME STATISTICS:

Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act and the Pennsylvania Act of 1988, Penn State publishes a combined Annual Security and Annual Fire Safety Report (ASR). The ASR includes crime statistics and institutional policies concerning campus security, such as those concerning alcohol and drug use, crime prevention, the reporting of crimes, sexual assault, and other matters. The ASR is available for review here (https://police.psu.edu/annual-security-reports) .

Employment with the University will require successful completion of background check(s) in accordance with University policies.

EEO IS THE LAW

Penn State is an equal opportunity, affirmative action employer, and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.

Federal Contractors Labor Law Poster (https://affirmativeaction.psu.edu/files/2022/01/Federal-Contractors-Labor-Law-Poster.pdf)

PA State Labor Law Poster

Affirmative Action (https://policy.psu.edu/policies/hr11)

Penn State Policies

Copyright Information (https://www.psu.edu/copyright-information)

Hotlines

Hershey, PA