University of Pennsylvania
Clinical Research Project Manager A/B (Abramson Cancer Center)
University of Pennsylvania, Phila, Pennsylvania, United States, 19117
University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Project Manager A/B (Abramson Cancer Center)
Job Profile Title
Clinical Research Project Manager A
Job Description Summary
The Pennsylvania Hospital Research Program of the University of Pennsylvania seeks a full-time Sr. Clinical Research Coordinator to contribute to a broad portfolio of therapeutic and non-therapeutic studies. This position will be responsible for assisting in the creation and implementation of policies and procedures for the Pennsylvania Hospital Clinical Research Unit (PAH CRU). This position will be responsible for direct oversight of the research personnel in the biospecimen process, shipping and inventory to ensure all regulatory, institutional and PAH CRU policies and procedures is followed. This position will be a resource for best practices of managing clinical trials, will provide guidance to both study trials and device trials. This position may assist in the development of investigator-initiated trials and have responsibilities in writing the protocol, database creation, data collection sheets, anaylsis and participant in presentations.
Job Description
Job Responsibilities
Clinical Research Project Manager A
Create and implement policy and procedures for carrying out the biospecimen and shipping process in accordance with IATA standards within the PAH CRU. Provide direct staff oversight in the biospecimen and shipping process.
Develop an inventory system for the PAH CRU. Implement and train the research personnel of the PAH CRU on the inventory process and provide direct oversight with ongoing inventory activities. Delegates and coordinates tasks based on developed systems and plans. Perform routine quality assurance (QA) checks on the inventory system and make changes as appropriate.
Coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Pennsylvania Hospital Clinical Research Unit (PAH CRU). Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by PAH CRU manager/leadership.
Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Communicate clinical trial patient activity to the Infusion Pharmacist at PAH and/or investigational drug pharmacy (IDS) to ensure adequate drug supply. Coordinate investigational agent supply ordering with sponsor and IDS as needed. Ensure drug accountability and appropriate investigational agent diary completion.
Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.
Act in lead capacity in coordination of PAH CRU research projects and assist Research Team Manager/Associate Director in overseeing execution of project timelines as well as completion of study related activities delegated to research staff who provides study related support (e.g., regulatory submissions and data entry).
May be responsible for writing investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Participate in the development/maintenance of electronic study specific case report form (i.e. REDCap, CRMS etc) and source document
tools. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts, and grant applications. May participate in and support budget preparation for trials as needed. May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team’s PM/PI as required.
Complete relevant training to function in the role including but not limited to electronic databases, processing/shipping specimens, phlebotomy, and ECG completion. Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes.
Other duties and responsibilities as assigned
Qualifications:
BS/BA required preferably in a life science area with a minimum of 3-5 years of job related experience with progressively more complex projects in a healthcare setting or an equivalent combination of education and experience. Ability to handle multiple projects simultaneously. Must have strong interpersonal skills and communication skills (both spoken and written), and be ready to provide examples of each. Must be highly motivated, independent and a self-starter. Proficiency in basic Microsoft Office applications, e.g. Access, Word, Excel, PowerPoint. Experience with oncology is a plus.
Clinical Research Project Manager B
The Clinical Research Project Manager B will have the same duties as A but will also include the following
Assist with the creation and implementation of policy and procedures to ensure streamlined and standardized processes for all research activities within the PAH CRU.
Asist with providing direct supervision for Clinical Research Coordinators, including onboarding and mentoring of new staff. Act as resource to current staff members with study related issues and as a back-up to the Research Manager when required.
Completing feasibility and study start up documents as required by sponsors for study initiation. Completing documents and providing the sponsor with PAH CRU requirements for site monitoring.
Assist in the coordination of grant applications for investigator-initiated trials.
Qualifications:
BS/BA required preferably in a life science area with CRPM-B qualifications Master's and 3-4 years of experience or an equivalent combination of education and experience with progressively more complex projects in a healthcare setting. Ability to handle multiple projects simultaneously. Must have strong interpersonal skills and communication skills (both spoken and written), and be ready to provide examples of each. Must be highly motivated, independent and a self-starter. Proficiency in basic Microsoft Office applications, e.g. Access, Word, Excel, PowerPoint. Experience with oncology is a plus.
Position contingent upon funding
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $89,789.00 Annual Rate
Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America’s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Project Manager A/B (Abramson Cancer Center)
Job Profile Title
Clinical Research Project Manager A
Job Description Summary
The Pennsylvania Hospital Research Program of the University of Pennsylvania seeks a full-time Sr. Clinical Research Coordinator to contribute to a broad portfolio of therapeutic and non-therapeutic studies. This position will be responsible for assisting in the creation and implementation of policies and procedures for the Pennsylvania Hospital Clinical Research Unit (PAH CRU). This position will be responsible for direct oversight of the research personnel in the biospecimen process, shipping and inventory to ensure all regulatory, institutional and PAH CRU policies and procedures is followed. This position will be a resource for best practices of managing clinical trials, will provide guidance to both study trials and device trials. This position may assist in the development of investigator-initiated trials and have responsibilities in writing the protocol, database creation, data collection sheets, anaylsis and participant in presentations.
Job Description
Job Responsibilities
Clinical Research Project Manager A
Create and implement policy and procedures for carrying out the biospecimen and shipping process in accordance with IATA standards within the PAH CRU. Provide direct staff oversight in the biospecimen and shipping process.
Develop an inventory system for the PAH CRU. Implement and train the research personnel of the PAH CRU on the inventory process and provide direct oversight with ongoing inventory activities. Delegates and coordinates tasks based on developed systems and plans. Perform routine quality assurance (QA) checks on the inventory system and make changes as appropriate.
Coordinate the conduct of complex (i.e., multi-drug regimens, high toxicity potential, multiple random assignments, or immunotherapies, etc.) Phase I – IV clinical trials and registries within the Pennsylvania Hospital Clinical Research Unit (PAH CRU). Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes. Organize, participate and assist in the preparation of documents needed for initiation, monitoring, internal and external auditing, and study close-out visits. Interface with regulatory authorities, Sponsors and cooperative groups as directed by PAH CRU manager/leadership.
Develop, schedule and oversee participant visits and any necessary testing and appointment coverage according to protocol and in accordance with Good Clinical Practice (GCP) (e.g. scheduling participant visits within the appropriate window, ensuring all tests and assessments at each visit are performed, reporting adverse events and ensuring review and appropriate follow-up by investigator, monitoring patient care and treatment side effects in concert with investigators, detailed documentation of study activities).
Monitor subjects per protocol requirements and ensure adherence to protocol. Show vigilance in patient safety, protocol compliance and data quality. Communicate clinical trial patient activity to the Infusion Pharmacist at PAH and/or investigational drug pharmacy (IDS) to ensure adequate drug supply. Coordinate investigational agent supply ordering with sponsor and IDS as needed. Ensure drug accountability and appropriate investigational agent diary completion.
Be actively involved in planning and implementation of patient recruitment into studies (involves deciding which strategies are best, reviewing medical records of upcoming new and return patient clinic visits and discussing with investigators, reaching out to potential referring physicians, approaching potential subjects in the office or speaking to them by phone, asking pre-screening eligibility questions, etc.). May participate in the clinic to explain a trial and conduct informed consent with the patient and family.
Act in lead capacity in coordination of PAH CRU research projects and assist Research Team Manager/Associate Director in overseeing execution of project timelines as well as completion of study related activities delegated to research staff who provides study related support (e.g., regulatory submissions and data entry).
May be responsible for writing investigator-initiated IND/IDE clinical trials in collaboration with faculty supervisor. Speak at investigator meetings or site initiation visits for IITs where collaborating physician is the Principal Investigator. Participate in the development/maintenance of electronic study specific case report form (i.e. REDCap, CRMS etc) and source document
tools. Assist in analyzing clinical data to determine response and clinical outcomes; contribute to the preparation of study abstracts, posters, manuscripts, and grant applications. May participate in and support budget preparation for trials as needed. May support a clinical trial budget through each phase of development, resolving issues and queries with input from the Research Team’s PM/PI as required.
Complete relevant training to function in the role including but not limited to electronic databases, processing/shipping specimens, phlebotomy, and ECG completion. Coordinate completion and appropriate documentation of new study staff training during any staffing transitions or for coverage purposes.
Other duties and responsibilities as assigned
Qualifications:
BS/BA required preferably in a life science area with a minimum of 3-5 years of job related experience with progressively more complex projects in a healthcare setting or an equivalent combination of education and experience. Ability to handle multiple projects simultaneously. Must have strong interpersonal skills and communication skills (both spoken and written), and be ready to provide examples of each. Must be highly motivated, independent and a self-starter. Proficiency in basic Microsoft Office applications, e.g. Access, Word, Excel, PowerPoint. Experience with oncology is a plus.
Clinical Research Project Manager B
The Clinical Research Project Manager B will have the same duties as A but will also include the following
Assist with the creation and implementation of policy and procedures to ensure streamlined and standardized processes for all research activities within the PAH CRU.
Asist with providing direct supervision for Clinical Research Coordinators, including onboarding and mentoring of new staff. Act as resource to current staff members with study related issues and as a back-up to the Research Manager when required.
Completing feasibility and study start up documents as required by sponsors for study initiation. Completing documents and providing the sponsor with PAH CRU requirements for site monitoring.
Assist in the coordination of grant applications for investigator-initiated trials.
Qualifications:
BS/BA required preferably in a life science area with CRPM-B qualifications Master's and 3-4 years of experience or an equivalent combination of education and experience with progressively more complex projects in a healthcare setting. Ability to handle multiple projects simultaneously. Must have strong interpersonal skills and communication skills (both spoken and written), and be ready to provide examples of each. Must be highly motivated, independent and a self-starter. Proficiency in basic Microsoft Office applications, e.g. Access, Word, Excel, PowerPoint. Experience with oncology is a plus.
Position contingent upon funding
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$51,824.00 - $89,789.00 Annual Rate
Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, as well as internal and market factors and grade profile.
Affirmative Action Statement Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits
Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family’s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.
Retirement: Penn offers generous retirement plans to help you save for your future. Penn’s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family—whatever your personal needs may be.
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you’re newly hired, you won’t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.
Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That’s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University’s libraries and athletic facilities, or visit our arboretum and art galleries. There’s always something going on at Penn, whether it’s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you’re right in the middle of the excitement—and you and your family can enjoy many of these activities for free.
Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
The University of Pennsylvania's special character is reflected in the diversity of the Penn community. We seek talented faculty and staff who will constitute a vibrant community that draws on the strength that comes with a substantive institutional commitment to diversity along dimensions of race, ethnicity, gender, sexual orientation, age, religion, disability, veteran status, interests, perspectives, and socioeconomic status. Grounded in equal opportunity, nondiscrimination, and affirmative action, Penn's robust commitment to diversity is fundamental to the University's mission of advancing knowledge, educating leaders for all sectors of society, and public service. The University of Pennsylvania prohibits unlawful discrimination based on race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.