Research Project Manager 1 - Pediatrics Hematology Oncology

• 
  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.
  

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  If you are NOT a current employee or student, please click “Apply” and complete the application process for external applicants .
  

JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Pediatric Hematology/Oncology Experimental Therapeutics program at the Penn State College of Medicine in Hershey, PA is seeking an experienced Research Project Manager. This position’s main responsibility is regulatory/compliance clinical trial support for the Experimental Therapeutics Research and Clinical Team (ExTRaCT). 

Responsibilities include, but not limited to, aiding in study feasibility determination, study start-up (such as site initiation visits, collection of essential documents, contract and budget facilitation, drafting of documents for scientific review, and preparation of IRB submission documents), regulatory study maintenance (such as IRB study binder creation and management of clinical study, reporting to IRB adverse events, safety reports, continuing review documents as well as IRB submission of protocol modifications and amendments),  and study closure (such as preparation, labeling, and filing of all study closure documentation from the IRB and study sponsor).

This person will assist the team in the preparation, facilitation and participation of monitoring visits and audits. This person will be a liaison regarding regulatory issues between ExTRaCT and study sponsors and relevant internal administrative departments, such as the CTO, HRPP, IDS and ORA. Additional responsibilities include assisting in identifying, screening, and enrolling eligible participants; participate in electronic data collection and organization; perform proper study specimen collection; and create and maintain SOPs.

This position involves working independently (with minimal supervision) on complex work assignments, perform clinical research in collaboration with other medical and nursing personnel and ancillary departments.  Familiarity with REDCAP and Microsoft Excel are necessary. Proficiency in time management, attention to detail and organization is critical to ensure effective and efficient data management. Excellent verbal and written communication skills are required. Prior oncology and/or pediatric clinical research experience is strongly preferred.
 

Bachelor's Degree or higher with 2+ years of related experience, or an equivalent of education and experience, is required.

This is a limited-term position funded for one year from date of hire, with excellent possibility of re-funding.

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. 

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 .

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 applications without regards to race, color, religion, age, sex, sexual orientation, gender identify, 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.

Affirmative Action

Penn State Policies

Copyright Information

Hotlines

Hershey, PA

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 .
  

JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Pediatric Hematology/Oncology Experimental Therapeutics program at the Penn State College of Medicine in Hershey, PA is seeking an experienced Research Project Manager. This position’s main responsibility is regulatory/compliance clinical trial support for the Experimental Therapeutics Research and Clinical Team (ExTRaCT). 

Responsibilities include, but not limited to, aiding in study feasibility determination, study start-up (such as site initiation visits, collection of essential documents, contract and budget facilitation, drafting of documents for scientific review, and preparation of IRB submission documents), regulatory study maintenance (such as IRB study binder creation and management of clinical study, reporting to IRB adverse events, safety reports, continuing review documents as well as IRB submission of protocol modifications and amendments),  and study closure (such as preparation, labeling, and filing of all study closure documentation from the IRB and study sponsor).

This person will assist the team in the preparation, facilitation and participation of monitoring visits and audits. This person will be a liaison regarding regulatory issues between ExTRaCT and study sponsors and relevant internal administrative departments, such as the CTO, HRPP, IDS and ORA. Additional responsibilities include assisting in identifying, screening, and enrolling eligible participants; participate in electronic data collection and organization; perform proper study specimen collection; and create and maintain SOPs.

This position involves working independently (with minimal supervision) on complex work assignments, perform clinical research in collaboration with other medical and nursing personnel and ancillary departments.  Familiarity with REDCAP and Microsoft Excel are necessary. Proficiency in time management, attention to detail and organization is critical to ensure effective and efficient data management. Excellent verbal and written communication skills are required. Prior oncology and/or pediatric clinical research experience is strongly preferred.
 

Bachelor's Degree or higher with 2+ years of related experience, or an equivalent of education and experience, is required.

This is a limited-term position funded for one year from date of hire, with excellent possibility of re-funding.

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. 

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 .

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 applications without regards to race, color, religion, age, sex, sexual orientation, gender identify, 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.

Affirmative Action

Penn State Policies

Copyright Information

Hotlines

Hershey, PA