University of Pennsylvania
Clinical Research Coordinator B (Department of Gastroenterology)
University of Pennsylvania, Medicine Lake, Minnesota, United States
Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This Ivy League institution consistently ranks among the top 10 universities in national surveys. Penn has 12 schools offering undergraduate, graduate, and continuing education opportunities, influenced by Penn’s interdisciplinary approach to scholarship and learning. Penn has been recognized as a best large employer in 2023 by Forbes.
Penn offers a unique working environment in Philadelphia with access to a range of educational, cultural, and recreational activities. The university provides a competitive benefits package including healthcare, tuition benefits for employees and families, retirement benefits, professional development opportunities, supportive work and family benefits, health and wellness programs, and more.
Posted Job Title Clinical Research Coordinator B (Department of Gastroenterology)
Job Profile Title Clinical Research Coordinator B
Job Description Summary The Division of Gastroenterology Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement investigator-initiated and industry-sponsored clinical trials of novel therapies or currently available therapies, as well as prospective and retrospective observational studies. This position reports to the Research Nurse Manager and works directly with Physician Investigators on clinical research performed. The CRC will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, follow-up and regulatory documentation. The successful candidate will comply with all Penn policies, Penn Medicine, FDA, GCP and other regulatory standards.
The CRC is an integral member of the Research Team. We seek an enthusiastic, professional and committed team member to help accelerate our program through the conduct of cutting-edge clinical trials.
Job Responsibilities
Coordinate Phase I – IV clinical trials.
Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (i.e., source documentation, case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs.
Recruit, screen and enroll potential study patients as specified per protocol.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.
Process and ship blood, urine, and serum specimens for each trial.
Schedule patient visits and any necessary testing; within the EMR or other tools.
Attend Investigator Initiation meetings.
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
Obtain records required to complete case report forms.
Maintain source documentation.
Ability to communicate and build rapport with subjects.
Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs.
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Coordinate and oversight on time to study start up.
Provide feedback and critical analysis of clinical research protocols.
Participate in CRF testing and potentially design.
Other duties and responsibilities as assigned.
Regulatory Responsibilities
Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and CROs.
Obtain the appropriate signatures for regulatory forms.
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs.
Qualifications
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience required.
This position is contingent upon grant funding.
Job Location - City, State Philadelphia, Pennsylvania
Department / School Perelman School of Medicine
Pay Range $52,500.00 - $56,000.00 Annual Rate
Salary offers are based on the candidate’s qualifications, experience, skills, and education as they relate to the position and aligned with external market data. Internal Penn data and peer data 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 (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any protected class under applicable federal, state, or local law.
Special Requirements Background checks may be required after a conditional job offer. Background check consideration 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, with pre-tax spending options.
Tuition : Tuition assistance for employee, spouse, and dependent children; eligible dependents may receive tuition assistance at other institutions.
Retirement : Generous retirement plans with pre-tax or Roth options, through plans such as TIAA and Vanguard.
Time Away from Work : Substantial paid time off for personal and family needs, vacations, and recovery.
Long-Term Care Insurance : Genworth partnership with no health proof for newly hired employees; eligibility rules apply for family members.
Wellness and Work-life Resources : Programs to support health, family, and work-life balance.
Professional and Personal Development : Resources to advance personal and professional growth.
University Resources : Access to libraries, athletic facilities, museums, and cultural venues with many activities available to Penn community members.
Discounts and Special Services : Discounts on arts, entertainment, transportation, mortgages, cellular plans, theme parks, and more.
Flexible Work Hours : Flexible options to support balance between work and personal commitments.
Penn Home Ownership Services : Forgivable loan for eligible employees for home purchases or improvements.
Adoption Assistance : Reimbursement for qualified adoption expenses for eligible families.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
#J-18808-Ljbffr
Penn offers a unique working environment in Philadelphia with access to a range of educational, cultural, and recreational activities. The university provides a competitive benefits package including healthcare, tuition benefits for employees and families, retirement benefits, professional development opportunities, supportive work and family benefits, health and wellness programs, and more.
Posted Job Title Clinical Research Coordinator B (Department of Gastroenterology)
Job Profile Title Clinical Research Coordinator B
Job Description Summary The Division of Gastroenterology Research Team seeks a full-time Clinical Research Coordinator to organize, coordinate and implement investigator-initiated and industry-sponsored clinical trials of novel therapies or currently available therapies, as well as prospective and retrospective observational studies. This position reports to the Research Nurse Manager and works directly with Physician Investigators on clinical research performed. The CRC will be responsible for all aspects of clinical trial coordination including subject recruitment, detailed data entry, subject visits, follow-up and regulatory documentation. The successful candidate will comply with all Penn policies, Penn Medicine, FDA, GCP and other regulatory standards.
The CRC is an integral member of the Research Team. We seek an enthusiastic, professional and committed team member to help accelerate our program through the conduct of cutting-edge clinical trials.
Job Responsibilities
Coordinate Phase I – IV clinical trials.
Coordinate, organize and maintain all documentation required by sponsor or Clinical Research Organizations (i.e., source documentation, case report forms, study and regulatory binders, and patient binders).
Resolve data queries with sponsor and CROs.
Recruit, screen and enroll potential study patients as specified per protocol.
Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required.
Process and ship blood, urine, and serum specimens for each trial.
Schedule patient visits and any necessary testing; within the EMR or other tools.
Attend Investigator Initiation meetings.
Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.
Obtain records required to complete case report forms.
Maintain source documentation.
Ability to communicate and build rapport with subjects.
Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs.
Show vigilance in patient safety, protocol compliance, and data quality.
Adhere to all University of Pennsylvania, ICF, and FDA guidelines.
Coordinate and oversight on time to study start up.
Provide feedback and critical analysis of clinical research protocols.
Participate in CRF testing and potentially design.
Other duties and responsibilities as assigned.
Regulatory Responsibilities
Prepare and process all Institutional Review Board (IRB) documentation through the IRB, including submissions, continuing reviews, amendments, and adverse event reporting.
Prepare and process all regulatory documentation with pharmaceutical companies and CROs.
Obtain the appropriate signatures for regulatory forms.
Organize and maintain all documentation required by sponsor or CRO (institutional forms, FDA Form 1572, deviation memos, physicians and coordinators’ CVs and medical licenses, record of IRB certification and compliance).
Resolve regulatory related queries with IRB, study sponsors and CROs.
Qualifications
Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience required.
This position is contingent upon grant funding.
Job Location - City, State Philadelphia, Pennsylvania
Department / School Perelman School of Medicine
Pay Range $52,500.00 - $56,000.00 Annual Rate
Salary offers are based on the candidate’s qualifications, experience, skills, and education as they relate to the position and aligned with external market data. Internal Penn data and peer data 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 (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any protected class under applicable federal, state, or local law.
Special Requirements Background checks may be required after a conditional job offer. Background check consideration 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, with pre-tax spending options.
Tuition : Tuition assistance for employee, spouse, and dependent children; eligible dependents may receive tuition assistance at other institutions.
Retirement : Generous retirement plans with pre-tax or Roth options, through plans such as TIAA and Vanguard.
Time Away from Work : Substantial paid time off for personal and family needs, vacations, and recovery.
Long-Term Care Insurance : Genworth partnership with no health proof for newly hired employees; eligibility rules apply for family members.
Wellness and Work-life Resources : Programs to support health, family, and work-life balance.
Professional and Personal Development : Resources to advance personal and professional growth.
University Resources : Access to libraries, athletic facilities, museums, and cultural venues with many activities available to Penn community members.
Discounts and Special Services : Discounts on arts, entertainment, transportation, mortgages, cellular plans, theme parks, and more.
Flexible Work Hours : Flexible options to support balance between work and personal commitments.
Penn Home Ownership Services : Forgivable loan for eligible employees for home purchases or improvements.
Adoption Assistance : Reimbursement for qualified adoption expenses for eligible families.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
#J-18808-Ljbffr