The Perelman School of Medicine
Clinical Research Coordinator B/C
The Perelman School of Medicine, Detroit, Michigan, United States, 48228
Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. 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 with access to a range of educational, cultural, and recreational activities. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, retirement benefits, professional development opportunities, work and family benefits, health and wellness programs and resources, and more. Posted Job Title: Clinical Research Coordinator B/C Job Profile Title: Clinical Research Coordinator B Job Description Summary: Clinical Research Coordinator B and C responsibilities within the Cardiovascular Division of PPMC, including study coordination, recruitment for industry-sponsored studies, direct work with study physicians and staff, patient screening/enrollment, follow-up assessments, data collection, use of EDC systems, adverse event assessment, patient and data safety, sample management, and proactive team communication. The Coordinator C role includes additional duties related to coordinating several investigational device trials in the cath lab and supporting investigators and staff on protocol requirements. Job Responsibilities (Clinical Research Coordinator B)
Assist in coordinating the conduct of assigned clinical trials performed by the physicians of Penn Cardiology and collaborate with principal investigators to assure research activities are conducted according to the currently approved protocol/amendments, Good Clinical Practice (GCP) guidelines, applicable federal and state requirements, and University policies. Provide oversight of administration of medications, study drugs or interventions and monitor subject care and status throughout the course of the study. Create and maintain research data, regulatory files, subject data and patient tracking databases. Ensure reported trial data are accurate, complete and verifiable from source documents; collect data on adverse events and report serious adverse events according to regulatory requirements. Prepare all documents for IRB review including draft informed consents written at subject reading levels. Assist in conducting initiation, monitoring and closeout visits with sponsors. Provide training and education for patient care staff in all aspects of trial initiation, conduct and closure. Serve as primary contact for subjects, sponsors and staff of research related University offices and hospital departments in nursing, pharmacy, billing, medical records related to assigned studies. Travel to attend investigator’s meetings presented by study sponsors. Job Responsibilities (Clinical Research Coordinator C)
Identify and recruit study subjects, screen regularly to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff, and by reviewing medical data. Recruit patients and explain protocol and consent forms. Ensure original signed consent forms are maintained in the study binder. Data entry – complete source documents and worksheets and complete and/or enter all clinical record forms (CRFs) in a timely manner. Obtain records required to complete CRFs. Resolve data queries. Organize and coordinate study procedures – schedule study visits within protocol designated time frames; ensure research orders and billing information are properly entered into the electronic medical record; ensure protocol dictated patient remuneration. Sample processing – process, label, and store human subject blood samples according to study protocol. Help manage sample inventory. Follow-up telephone calls/interviews – conduct study visits, including administering questionnaires, escorting patients to protocol-required tests and procedures. Assist with completing and maintaining regulatory correspondence under the direction of the research director. Participate in monitoring visit/audit preparation and follow-up. Provide subject and family education and support. Ensure subjects are educated regarding the protocol specifics and study drugs/devices. Assist interventionalists in investigational device trials, device dispensing/accountability. Perform additional duties as assigned. Provide in-service training and education to Penn Medicine inpatient/cath lab cardiology nurses. Support and train new research coordinators. Review all new trials in the cath lab to help identify challenges and implement plans to solve them. Qualifications
Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. 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 - $67,046.00 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 (including shared ancestry or ethnic characteristics), 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 may be used for eligible expenses with pre-tax dollars. Tuition : Tuition assistance for employee, spouse, and dependent children; dependent children eligible for tuition assistance at other institutions. Retirement : Generous retirement plans with pre-tax or Roth options; investment options through TIAA and Vanguard. Time Away from Work : Substantial paid time off for vacations, personal matters, illness, or family needs. Long-Term Care Insurance : In partnership with Genworth Financial, long-term care insurance options for employees and eligible family members. Wellness and Work-life Resources : Programs to support health, family, and work-life balance. Professional and Personal Development : Resources to help you advance personally and professionally. University Resources : Access to libraries, athletic facilities, arboretum, art galleries, and more; many activities available to Penn community, often at no or reduced cost. Discounts and Special Services : Discounts on arts, entertainment, transportation, cars, cell plans, tickets, theme parks, and more. Flexible Work Hours : Flexible work options to support balance between work and commitments. Penn Home Ownership Services : Forgivable loan for eligible employees buying a home or in West Philadelphia, usable for closing costs or improvements. Adoption Assistance : Reimbursement for qualified adoption expenses up to two adoptions per household. To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. 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 with access to a range of educational, cultural, and recreational activities. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, retirement benefits, professional development opportunities, work and family benefits, health and wellness programs and resources, and more. Posted Job Title: Clinical Research Coordinator B/C Job Profile Title: Clinical Research Coordinator B Job Description Summary: Clinical Research Coordinator B and C responsibilities within the Cardiovascular Division of PPMC, including study coordination, recruitment for industry-sponsored studies, direct work with study physicians and staff, patient screening/enrollment, follow-up assessments, data collection, use of EDC systems, adverse event assessment, patient and data safety, sample management, and proactive team communication. The Coordinator C role includes additional duties related to coordinating several investigational device trials in the cath lab and supporting investigators and staff on protocol requirements. Job Responsibilities (Clinical Research Coordinator B)
Assist in coordinating the conduct of assigned clinical trials performed by the physicians of Penn Cardiology and collaborate with principal investigators to assure research activities are conducted according to the currently approved protocol/amendments, Good Clinical Practice (GCP) guidelines, applicable federal and state requirements, and University policies. Provide oversight of administration of medications, study drugs or interventions and monitor subject care and status throughout the course of the study. Create and maintain research data, regulatory files, subject data and patient tracking databases. Ensure reported trial data are accurate, complete and verifiable from source documents; collect data on adverse events and report serious adverse events according to regulatory requirements. Prepare all documents for IRB review including draft informed consents written at subject reading levels. Assist in conducting initiation, monitoring and closeout visits with sponsors. Provide training and education for patient care staff in all aspects of trial initiation, conduct and closure. Serve as primary contact for subjects, sponsors and staff of research related University offices and hospital departments in nursing, pharmacy, billing, medical records related to assigned studies. Travel to attend investigator’s meetings presented by study sponsors. Job Responsibilities (Clinical Research Coordinator C)
Identify and recruit study subjects, screen regularly to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff, and by reviewing medical data. Recruit patients and explain protocol and consent forms. Ensure original signed consent forms are maintained in the study binder. Data entry – complete source documents and worksheets and complete and/or enter all clinical record forms (CRFs) in a timely manner. Obtain records required to complete CRFs. Resolve data queries. Organize and coordinate study procedures – schedule study visits within protocol designated time frames; ensure research orders and billing information are properly entered into the electronic medical record; ensure protocol dictated patient remuneration. Sample processing – process, label, and store human subject blood samples according to study protocol. Help manage sample inventory. Follow-up telephone calls/interviews – conduct study visits, including administering questionnaires, escorting patients to protocol-required tests and procedures. Assist with completing and maintaining regulatory correspondence under the direction of the research director. Participate in monitoring visit/audit preparation and follow-up. Provide subject and family education and support. Ensure subjects are educated regarding the protocol specifics and study drugs/devices. Assist interventionalists in investigational device trials, device dispensing/accountability. Perform additional duties as assigned. Provide in-service training and education to Penn Medicine inpatient/cath lab cardiology nurses. Support and train new research coordinators. Review all new trials in the cath lab to help identify challenges and implement plans to solve them. Qualifications
Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required. 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 - $67,046.00 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 (including shared ancestry or ethnic characteristics), 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 may be used for eligible expenses with pre-tax dollars. Tuition : Tuition assistance for employee, spouse, and dependent children; dependent children eligible for tuition assistance at other institutions. Retirement : Generous retirement plans with pre-tax or Roth options; investment options through TIAA and Vanguard. Time Away from Work : Substantial paid time off for vacations, personal matters, illness, or family needs. Long-Term Care Insurance : In partnership with Genworth Financial, long-term care insurance options for employees and eligible family members. Wellness and Work-life Resources : Programs to support health, family, and work-life balance. Professional and Personal Development : Resources to help you advance personally and professionally. University Resources : Access to libraries, athletic facilities, arboretum, art galleries, and more; many activities available to Penn community, often at no or reduced cost. Discounts and Special Services : Discounts on arts, entertainment, transportation, cars, cell plans, tickets, theme parks, and more. Flexible Work Hours : Flexible work options to support balance between work and commitments. Penn Home Ownership Services : Forgivable loan for eligible employees buying a home or in West Philadelphia, usable for closing costs or improvements. Adoption Assistance : Reimbursement for qualified adoption expenses up to two adoptions per household. To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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