The Pennsylvania State University
Research Integration Project Manager
The Pennsylvania State University, Hershey, Pennsylvania, United States, 17033
POSITION SPECIFICS
The Research Integration Project Manager position acts as the Liaison for research activities between Penn State Health (PSH) practice sites (excluding Hershey Medical Center) and Penn State University (PSU)/College of Medicine (COM) for the purpose of integrating research into PSU/COM standardized processes and policies. As the research integration liaison, this position works closely with COM research departments including the COM Clinical Trials Office (CTO), COM Office of Research Affairs (ORA), and many other COM research departments. It also works closely with PSH Investigational Drug Services, PSH Heart and Vascular Institute, PSH Cancer Institute, PSH offices of Mission and Ministry, PSH Patient Financial Services, PSH Compliance offices, PSH St. Joseph medical and pharmacy residency programs, and additional Penn State Health offices as clinical enterprise needs dictate. This position also liaises and collaborates directly with various University Park enterprise offices, including the Office of Research Protections (ORP) and the Office of Research Information Systems (ORIS) and others as needed. Serves as facilitator to resolve issues between clinical research department/practice sites, research staff, hospital departments, legal department, administration and external partners. Communicates procedural changes to ensure compliance with COM research requirements and assists clinical and research offices to ensure policies are being followed across the Penn State Health non-Hershey practice sites. In this role the incumbent also serves as a resource for Clinical Research inquiries and education for non-Hershey based practice site staff. As a member of the COM Research Integration team, responsible for assisting the Research Integration Program manager with all aspects of the Research Integration Program including project and operational work. Assists in defining and operationalizing research integration processes and policies. Co-responsibilities include: Onboarding newly integrated practice sites to: Orient and train non-Hershey based research staff to ensure PSU/COM research policies and procedures replace any local research policies Facilitate transfer of Assignment agreements for site research studies and contracts from the practice site to the COM Facilitate access to PSU/COM research systems Interface with external collaborators to direct and facilitate multi-site and collaborative research as needed Co-managing research integration operations including: Collaborating with PSH leadership of clinical units, departments, or centers to develop strategic partnerships, advance the mission of research initiatives and projects and increase the research portfolio Facilitating Intake of new research projects submitted by non-Hershey practice sites Providing leadership and oversight for operationalizing all clinical trials conducted at Penn State Health non-Hershey based sites Communicating with the offices of Mission and Ministry at all Penn State Health Catholic hospitals Working with clinical PSH clinical service lines and COM central research offices to design and implement research integration work-flow processes Building a sustainable research integration program by: Strategically building and operationalizing an enterprise-wide Clinical Research Operations Group (CROG) who serve as Governance for Penn State Health research Analyzing research integration workflow, practices and outcomes to measure alignment with organizational goals and objectives and suggesting process changes to improve expected outcomes as needed The position is mainly a remote position with occasional on-site meetings as required. The incumbent works with relevant COM and PSH research management teams to integrate and provide integration oversight for all clinical trials that include investigational drug, device, procedure and data collection protocols that are conducted at or associated with non-Hershey based Penn State Health practice sites. As the research integration liaison, the preference is that the incumbent should be familiar with: Clinical trial billing regulations, Good Clinical Practices, FDA regulations, Federal Wide Assurance (FWA) and Office of Human Research Protections (OHRP) Policy and Procedure in accordance with Federal and State Law regarding human subject research Familiarity with COM systems such as CATS IRB, SIMS, COINS, MyResearch Portal and others is a plus Some knowledge of PSH systems including Cerner suite of products, Epic, Infonet, and others as needed is preferred MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS Master's Degree 3+ years of relevant experience; or an equivalent combination of education and experience accepted. Certifications: None. Travel to non-Hershey based sites will be occasionally required. APPLICATION INSTRUCTIONS CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. 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. 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. Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants. BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of background checks 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 $68,200.00 - $102,300.00. Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. Includes medical, dental, and vision coverage, retirement plans, paid time off, and a 75% tuition discount for employees and eligible dependents. Detailed information is available on the Benefits Page. EEO & COMPLIANCE Penn State is an equal opportunity 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. Additional university compliance information: Campus Security Crime Statistics (ASR), Federal Contractors Labor Law Poster, PA State Labor Law Poster, Penn State Policies, Copyright Information, and Hotline information are available as part of the university disclosures.
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The Research Integration Project Manager position acts as the Liaison for research activities between Penn State Health (PSH) practice sites (excluding Hershey Medical Center) and Penn State University (PSU)/College of Medicine (COM) for the purpose of integrating research into PSU/COM standardized processes and policies. As the research integration liaison, this position works closely with COM research departments including the COM Clinical Trials Office (CTO), COM Office of Research Affairs (ORA), and many other COM research departments. It also works closely with PSH Investigational Drug Services, PSH Heart and Vascular Institute, PSH Cancer Institute, PSH offices of Mission and Ministry, PSH Patient Financial Services, PSH Compliance offices, PSH St. Joseph medical and pharmacy residency programs, and additional Penn State Health offices as clinical enterprise needs dictate. This position also liaises and collaborates directly with various University Park enterprise offices, including the Office of Research Protections (ORP) and the Office of Research Information Systems (ORIS) and others as needed. Serves as facilitator to resolve issues between clinical research department/practice sites, research staff, hospital departments, legal department, administration and external partners. Communicates procedural changes to ensure compliance with COM research requirements and assists clinical and research offices to ensure policies are being followed across the Penn State Health non-Hershey practice sites. In this role the incumbent also serves as a resource for Clinical Research inquiries and education for non-Hershey based practice site staff. As a member of the COM Research Integration team, responsible for assisting the Research Integration Program manager with all aspects of the Research Integration Program including project and operational work. Assists in defining and operationalizing research integration processes and policies. Co-responsibilities include: Onboarding newly integrated practice sites to: Orient and train non-Hershey based research staff to ensure PSU/COM research policies and procedures replace any local research policies Facilitate transfer of Assignment agreements for site research studies and contracts from the practice site to the COM Facilitate access to PSU/COM research systems Interface with external collaborators to direct and facilitate multi-site and collaborative research as needed Co-managing research integration operations including: Collaborating with PSH leadership of clinical units, departments, or centers to develop strategic partnerships, advance the mission of research initiatives and projects and increase the research portfolio Facilitating Intake of new research projects submitted by non-Hershey practice sites Providing leadership and oversight for operationalizing all clinical trials conducted at Penn State Health non-Hershey based sites Communicating with the offices of Mission and Ministry at all Penn State Health Catholic hospitals Working with clinical PSH clinical service lines and COM central research offices to design and implement research integration work-flow processes Building a sustainable research integration program by: Strategically building and operationalizing an enterprise-wide Clinical Research Operations Group (CROG) who serve as Governance for Penn State Health research Analyzing research integration workflow, practices and outcomes to measure alignment with organizational goals and objectives and suggesting process changes to improve expected outcomes as needed The position is mainly a remote position with occasional on-site meetings as required. The incumbent works with relevant COM and PSH research management teams to integrate and provide integration oversight for all clinical trials that include investigational drug, device, procedure and data collection protocols that are conducted at or associated with non-Hershey based Penn State Health practice sites. As the research integration liaison, the preference is that the incumbent should be familiar with: Clinical trial billing regulations, Good Clinical Practices, FDA regulations, Federal Wide Assurance (FWA) and Office of Human Research Protections (OHRP) Policy and Procedure in accordance with Federal and State Law regarding human subject research Familiarity with COM systems such as CATS IRB, SIMS, COINS, MyResearch Portal and others is a plus Some knowledge of PSH systems including Cerner suite of products, Epic, Infonet, and others as needed is preferred MINIMUM EDUCATION, WORK EXPERIENCE & REQUIRED CERTIFICATIONS Master's Degree 3+ years of relevant experience; or an equivalent combination of education and experience accepted. Certifications: None. Travel to non-Hershey based sites will be occasionally required. APPLICATION INSTRUCTIONS CURRENT PENN STATE EMPLOYEE (faculty, staff, technical service, or student), please login to Workday to complete the internal application process. 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. 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. Approval of remote and hybrid work is not guaranteed regardless of work location. For additional information on remote work at Penn State, see Notice to Out of State Applicants. BACKGROUND CHECKS/CLEARANCES Employment with the University will require successful completion of background checks 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 $68,200.00 - $102,300.00. Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being. Includes medical, dental, and vision coverage, retirement plans, paid time off, and a 75% tuition discount for employees and eligible dependents. Detailed information is available on the Benefits Page. EEO & COMPLIANCE Penn State is an equal opportunity 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. Additional university compliance information: Campus Security Crime Statistics (ASR), Federal Contractors Labor Law Poster, PA State Labor Law Poster, Penn State Policies, Copyright Information, and Hotline information are available as part of the university disclosures.
#J-18808-Ljbffr