University of Pennsylvania
Clinical Research Coordinator B/C (Abramson Cancer Center)
University of Pennsylvania, Medicine Lake, Minnesota, United States
Overview
The University of Pennsylvania is a private employer with a long-standing tradition in education, research, and innovation. Penn offers opportunities for undergraduate, graduate and continuing education, and emphasizes interdisciplinary scholarship. Penn has been recognized as one of America’s Best Large Employers in 2023 by Forbes. Penn provides a competitive benefits package including healthcare, tuition benefits for employees and families, retirement plans, professional development, supportive work and family benefits, wellness programs, and more. Posted Job Title Clinical Research Coordinator B/C (Abramson Cancer Center) Job Profile Title Clinical Research Coordinator B Job Description Summary The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU supports disease/discipline specific medical oncology cancer programs within the ACC and is comprised of 12 Research Teams. The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (“Lymphoma Research Team”) within the ACC CRU seeks a full-time Clinical Research Coordinator B/C (CRC). The successful candidate will (1) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO. This position reports to the Program Manager and works with PIs and clinical research nurses (CRNs). The CRC is an integral and essential member of the ACC CRU Lymphoma Research Team. We seek an enthusiastic, professional, and committed team member to collaborate with investigators, team leaders, CRNs, and other research staff. The ACC has received an exceptional rating from the National Cancer Institute (NCI) and is considered a top cancer center. We aim to accelerate this momentum through cutting-edge clinical trials. Job Description Job Responsibilities
Clinical Research Coordinator B Responsibilities: This individual will work under general supervision. Specific responsibilities include (but are not limited to): Plan, organize, and contribute to study-related meetings, including Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits, and ongoing training sessions; maintain complete and accurate records of meetings/sessions, and ensure action items are completed in a timely manner. Assist with start-up processes for Industry-sponsored, Cooperative Group, and Investigator-initiated studies; review protocols and manuals, pursue corrections or clarifications as needed; coordinate non-therapeutic studies and complex Phase I, II, or III oncology trials. Assist the Regulatory Coordinator by preparing components of submissions and drafting responses to IRB stipulations; monitor regulatory statuses for assigned protocols. Lead or contribute to Informed Consent in accordance with federal and state law. Review inclusion/exclusion criteria and facilitate eligibility review with Sponsor/CRO as required. Provide support to faculty and staff during study-related visits; document visits and testing; coordinate exception requests and deviations; document and report adverse events and other events. Collect, review and report data in accordance with study timelines; resolve data discrepancies and respond to sponsor queries; manage deviations and other events. Coordinate independent central review of end-points (e.g., imaging data); manage transport and processing of biological materials; assist with billing reconciliation and patient stipends; may assist with research scheduling. Maintain complete, organized, audit-ready study and participant files; secure signatures and forward documents; maintain Delegation of Authority log. Participate in research meetings and Sponsor/CRO teleconferences; provide coverage to meet departmental needs; maintain trainings and certifications (e.g., CITI, GCP, IATA, Penn CRC Certificate, Penn Profiler trainings). Perform other duties as reasonably assigned. Clinical Research Coordinator C Responsibilities: The CRC C will work independently under minimal supervision and may act in a lead capacity or as back-up to the Supervisor. Responsibilities are the same as B but with additional duties: Plan, organize, and run study-related meetings and ongoing trainings. Lead Site Feasibility and Qualification Visits; initiate start-up processes for industry-sponsored and Investigator-initiated trials; manage complex Phase I–IV trials including multi-site projects where Penn is the lead site. Prepare submissions to IRB and other entities; monitor regulatory statuses; may edit study protocols and related documents. Develop study-specific Case Report Forms; contribute to study reports, abstracts, posters, manuscripts, and grant applications. Participate in Sponsor teleconferences and Program meetings; mentor new staff and support others as needed; provide coverage to meet staffing needs. Assist Unit Managers with QA processes; lead preparation for inspections and audits as required. Position may involve some work outside usual hours and travel. Position contingent on continued funding. Qualifications: Clinical Research Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. Clinical Research Coordinator C: Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $52,500.00 - $60,813.00 Annual Rate Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin, citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be 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. Flexible spending accounts can be used for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Tuition assistance for employee and eligible family members; spouses and dependent children may also receive support at Penn and other institutions for dependents.
Retirement : Generous retirement plans with pretax or Roth options; access to investment choices through TIAA and Vanguard.
Time Away from Work : Substantial time away from work for personal needs, vacations, illness recovery, or family time.
Long-Term Care Insurance : In partnership with Genworth Financial; eligible employees and family members may receive long-term care insurance with favorable underwriting terms for new hires.
Wellness and Work-life Resources : Programs and resources to balance work and personal life, including health, family, and work-life balance supports.
Professional and Personal Development : Resources to advance professionally and personally.
University Resources : Access to libraries, athletic facilities, and cultural activities; many activities may be enjoyed with family at no or reduced cost.
Discounts and Special Services : Discounts on arts, entertainment, transportation, cars, cellular plans, tickets, and theme parks.
Flexible Work Hours : Flexible options for non-traditional hours, locations, and structures to promote balance.
Penn Home Ownership Services : Forgivable loan for eligible employees in West Philadelphia for home purchase or improvements.
Adoption Assistance : Reimbursement of eligible adoption-related expenses up to two adoptions per household.
To learn more, please visit: Penn HR Benefits
#J-18808-Ljbffr
The University of Pennsylvania is a private employer with a long-standing tradition in education, research, and innovation. Penn offers opportunities for undergraduate, graduate and continuing education, and emphasizes interdisciplinary scholarship. Penn has been recognized as one of America’s Best Large Employers in 2023 by Forbes. Penn provides a competitive benefits package including healthcare, tuition benefits for employees and families, retirement plans, professional development, supportive work and family benefits, wellness programs, and more. Posted Job Title Clinical Research Coordinator B/C (Abramson Cancer Center) Job Profile Title Clinical Research Coordinator B Job Description Summary The Abramson Cancer Center (ACC) of the University of Pennsylvania is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The mission of the ACC Clinical Research Unit (CRU) is to advance the science of cancer care, serve our patients by improving clinical outcomes, and offer the best available innovative care to trial participants. The ACC CRU supports disease/discipline specific medical oncology cancer programs within the ACC and is comprised of 12 Research Teams. The Clinical and Translational Research Program for Lymphomas and Other Related Diseases (“Lymphoma Research Team”) within the ACC CRU seeks a full-time Clinical Research Coordinator B/C (CRC). The successful candidate will (1) ensure the accurate execution of research protocols in accordance with Good Clinical Practices, HIPAA, and other federal/institutional requirements, and (2) meet required obligations to patients/subjects, Principal Investigator (PI), study team and Sponsor/CRO. This position reports to the Program Manager and works with PIs and clinical research nurses (CRNs). The CRC is an integral and essential member of the ACC CRU Lymphoma Research Team. We seek an enthusiastic, professional, and committed team member to collaborate with investigators, team leaders, CRNs, and other research staff. The ACC has received an exceptional rating from the National Cancer Institute (NCI) and is considered a top cancer center. We aim to accelerate this momentum through cutting-edge clinical trials. Job Description Job Responsibilities
Clinical Research Coordinator B Responsibilities: This individual will work under general supervision. Specific responsibilities include (but are not limited to): Plan, organize, and contribute to study-related meetings, including Investigator Meetings, Site Initiation Visits, Intermediate Monitoring Visits, Close-out Visits, Internal Audits, and ongoing training sessions; maintain complete and accurate records of meetings/sessions, and ensure action items are completed in a timely manner. Assist with start-up processes for Industry-sponsored, Cooperative Group, and Investigator-initiated studies; review protocols and manuals, pursue corrections or clarifications as needed; coordinate non-therapeutic studies and complex Phase I, II, or III oncology trials. Assist the Regulatory Coordinator by preparing components of submissions and drafting responses to IRB stipulations; monitor regulatory statuses for assigned protocols. Lead or contribute to Informed Consent in accordance with federal and state law. Review inclusion/exclusion criteria and facilitate eligibility review with Sponsor/CRO as required. Provide support to faculty and staff during study-related visits; document visits and testing; coordinate exception requests and deviations; document and report adverse events and other events. Collect, review and report data in accordance with study timelines; resolve data discrepancies and respond to sponsor queries; manage deviations and other events. Coordinate independent central review of end-points (e.g., imaging data); manage transport and processing of biological materials; assist with billing reconciliation and patient stipends; may assist with research scheduling. Maintain complete, organized, audit-ready study and participant files; secure signatures and forward documents; maintain Delegation of Authority log. Participate in research meetings and Sponsor/CRO teleconferences; provide coverage to meet departmental needs; maintain trainings and certifications (e.g., CITI, GCP, IATA, Penn CRC Certificate, Penn Profiler trainings). Perform other duties as reasonably assigned. Clinical Research Coordinator C Responsibilities: The CRC C will work independently under minimal supervision and may act in a lead capacity or as back-up to the Supervisor. Responsibilities are the same as B but with additional duties: Plan, organize, and run study-related meetings and ongoing trainings. Lead Site Feasibility and Qualification Visits; initiate start-up processes for industry-sponsored and Investigator-initiated trials; manage complex Phase I–IV trials including multi-site projects where Penn is the lead site. Prepare submissions to IRB and other entities; monitor regulatory statuses; may edit study protocols and related documents. Develop study-specific Case Report Forms; contribute to study reports, abstracts, posters, manuscripts, and grant applications. Participate in Sponsor teleconferences and Program meetings; mentor new staff and support others as needed; provide coverage to meet staffing needs. Assist Unit Managers with QA processes; lead preparation for inspections and audits as required. Position may involve some work outside usual hours and travel. Position contingent on continued funding. Qualifications: Clinical Research Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. Clinical Research Coordinator C: Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $52,500.00 - $60,813.00 Annual Rate Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin, citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be 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. Flexible spending accounts can be used for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Tuition assistance for employee and eligible family members; spouses and dependent children may also receive support at Penn and other institutions for dependents.
Retirement : Generous retirement plans with pretax or Roth options; access to investment choices through TIAA and Vanguard.
Time Away from Work : Substantial time away from work for personal needs, vacations, illness recovery, or family time.
Long-Term Care Insurance : In partnership with Genworth Financial; eligible employees and family members may receive long-term care insurance with favorable underwriting terms for new hires.
Wellness and Work-life Resources : Programs and resources to balance work and personal life, including health, family, and work-life balance supports.
Professional and Personal Development : Resources to advance professionally and personally.
University Resources : Access to libraries, athletic facilities, and cultural activities; many activities may be enjoyed with family at no or reduced cost.
Discounts and Special Services : Discounts on arts, entertainment, transportation, cars, cellular plans, tickets, and theme parks.
Flexible Work Hours : Flexible options for non-traditional hours, locations, and structures to promote balance.
Penn Home Ownership Services : Forgivable loan for eligible employees in West Philadelphia for home purchase or improvements.
Adoption Assistance : Reimbursement of eligible adoption-related expenses up to two adoptions per household.
To learn more, please visit: Penn HR Benefits
#J-18808-Ljbffr